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Obana A, Akabane M, Chi H, Ladd N, Yoder M, Kaufman L, Punjala R, Shah K, Hamilton M, Limkemann A, Schenk A, Singh N, Slyvester B, Mumtaz K, Washburn K, Alebrahim M. Does Weekend Discharge Affect Readmission and Survival in Liver Transplant Patients? Insights From a Cohort Study. Clin Transplant 2025; 39:e70081. [PMID: 39792580 DOI: 10.1111/ctr.70081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2024] [Revised: 11/21/2024] [Accepted: 01/01/2025] [Indexed: 01/12/2025]
Abstract
BACKGROUND Weekend hospital discharges are often associated with reduced staffing, potentially impacting the quality of patient care. We studied the effects of weekend discharge after liver transplantation (LT) on early readmission rates, overall survival (OS), and graft survival (GS). METHOD We analyzed data from the Ohio State University Wexner Medical Center database (January 2016 to December 2023). The study included initial LT recipients (LTRs) including donation after brain death (DBD) and donation after cardiac death (DCD). Primary outcomes encompassed early readmission rates, and secondary outcomes included OS and GS. RESULTS The cohort comprised 915 LTRs (645 DBD, 270 DCD), with 156 (17.0%) weekend and 759 (83.0%) weekday discharges. Regarding discharge disposition, 681 (74.4%) patients were discharged home, 210 (22.9%) were discharged to healthcare facilities. No significant differences were identified in the length of hospital stay (8 days vs. 9 days, weekend vs. weekday, respectively, p = 0.22) or 30-day readmission (29.5% vs. 32.5%, weekend vs. weekday, respectively, p = 0.75). There were no significant differences in OS (90.9% vs. 92.7% at 1-year, 84.4% vs. 88.0% at 3-year, weekend vs. weekday, p = 0.27) and GS (90.9% vs. 91.5% at 1-year, 84.0% vs. 86.6% at 3-year, weekend vs. weekday, p = 0.50). Multivariate logistic analysis showed no significant impact of weekend discharge (OR: 0.84 [0.57-1.22], p = 0.35) or discharge disposition (OR: 1.00 [0.75-1.33], p = 1.00) on 30-day readmission. Multivariate Cox regression analysis found no significant impact of weekend discharge or discharge disposition on OS and GS (all p > 0.05). CONCLUSION Weekend discharge does not impact early readmission, OS, or GS in LTRs. These findings are a testament to our multidisciplinary team efforts and suggest that with appropriate discharge planning and follow-up care, the timing of discharge may be less critical than previously assumed.
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Affiliation(s)
- Ayato Obana
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Miho Akabane
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Hannah Chi
- Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Nolan Ladd
- Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Matthew Yoder
- Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Lily Kaufman
- Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Rithin Punjala
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Kejal Shah
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Matthew Hamilton
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Ashley Limkemann
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Austin Schenk
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Navdeep Singh
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Black Slyvester
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Khalid Mumtaz
- Department of Hepatology, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Kenneth Washburn
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Musab Alebrahim
- Department of Surgery, Comprehensive Transplant Center, Ohio State University Wexner Medical Center, Columbus, Ohio, USA
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Berg T, Aehling NF, Bruns T, Welker MW, Weismüller T, Trebicka J, Tacke F, Strnad P, Sterneck M, Settmacher U, Seehofer D, Schott E, Schnitzbauer AA, Schmidt HH, Schlitt HJ, Pratschke J, Pascher A, Neumann U, Manekeller S, Lammert F, Klein I, Kirchner G, Guba M, Glanemann M, Engelmann C, Canbay AE, Braun F, Berg CP, Bechstein WO, Becker T, Trautwein C. [Not Available]. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2024; 62:1397-1573. [PMID: 39250961 DOI: 10.1055/a-2255-7246] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 09/11/2024]
Affiliation(s)
- Thomas Berg
- Bereich Hepatologie, Medizinischen Klinik II, Universitätsklinikum Leipzig, Leipzig, Deutschland
| | - Niklas F Aehling
- Bereich Hepatologie, Medizinischen Klinik II, Universitätsklinikum Leipzig, Leipzig, Deutschland
| | - Tony Bruns
- Medizinische Klinik III, Universitätsklinikum Aachen, Aachen, Deutschland
| | - Martin-Walter Welker
- Medizinische Klinik I Gastroent., Hepat., Pneum., Endokrin. Universitätsklinikum Frankfurt, Frankfurt, Deutschland
| | - Tobias Weismüller
- Klinik für Innere Medizin - Gastroenterologie und Hepatologie, Vivantes Humboldt-Klinikum, Berlin, Deutschland
| | - Jonel Trebicka
- Medizinische Klinik B für Gastroenterologie und Hepatologie, Universitätsklinikum Münster, Münster, Deutschland
| | - Frank Tacke
- Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Hepatologie und Gastroenterologie, Campus Virchow-Klinikum (CVK) und Campus Charité Mitte (CCM), Berlin, Deutschland
| | - Pavel Strnad
- Medizinische Klinik III, Universitätsklinikum Aachen, Aachen, Deutschland
| | - Martina Sterneck
- Medizinische Klinik und Poliklinik I, Universitätsklinikum Hamburg, Hamburg, Deutschland
| | - Utz Settmacher
- Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Universitätsklinikum Jena, Jena, Deutschland
| | - Daniel Seehofer
- Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig, Deutschland
| | - Eckart Schott
- Klinik für Innere Medizin II - Gastroenterologie, Hepatologie und Diabetolgie, Helios Klinikum Emil von Behring, Berlin, Deutschland
| | | | - Hartmut H Schmidt
- Klinik für Gastroenterologie und Hepatologie, Universitätsklinikum Essen, Essen, Deutschland
| | - Hans J Schlitt
- Klinik und Poliklinik für Chirurgie, Universitätsklinikum Regensburg, Regensburg, Deutschland
| | - Johann Pratschke
- Chirurgische Klinik, Charité Campus Virchow-Klinikum - Universitätsmedizin Berlin, Berlin, Deutschland
| | - Andreas Pascher
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Münster, Münster, Deutschland
| | - Ulf Neumann
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen, Deutschland
| | - Steffen Manekeller
- Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Bonn, Bonn, Deutschland
| | - Frank Lammert
- Medizinische Hochschule Hannover (MHH), Hannover, Deutschland
| | - Ingo Klein
- Chirurgische Klinik I, Universitätsklinikum Würzburg, Würzburg, Deutschland
| | - Gabriele Kirchner
- Klinik und Poliklinik für Chirurgie, Universitätsklinikum Regensburg und Innere Medizin I, Caritaskrankenhaus St. Josef Regensburg, Regensburg, Deutschland
| | - Markus Guba
- Klinik für Allgemeine, Viszeral-, Transplantations-, Gefäß- und Thoraxchirurgie, Universitätsklinikum München, München, Deutschland
| | - Matthias Glanemann
- Klinik für Allgemeine, Viszeral-, Gefäß- und Kinderchirurgie, Universitätsklinikum des Saarlandes, Homburg, Deutschland
| | - Cornelius Engelmann
- Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Hepatologie und Gastroenterologie, Campus Virchow-Klinikum (CVK) und Campus Charité Mitte (CCM), Berlin, Deutschland
| | - Ali E Canbay
- Medizinische Klinik, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Deutschland
| | - Felix Braun
- Klinik für Allgemeine Chirurgie, Viszeral-, Thorax-, Transplantations- und Kinderchirurgie, Universitätsklinikum Schlewswig-Holstein, Kiel, Deutschland
| | - Christoph P Berg
- Innere Medizin I Gastroenterologie, Hepatologie, Infektiologie, Universitätsklinikum Tübingen, Tübingen, Deutschland
| | - Wolf O Bechstein
- Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt, Deutschland
| | - Thomas Becker
- Klinik für Allgemeine Chirurgie, Viszeral-, Thorax-, Transplantations- und Kinderchirurgie, Universitätsklinikum Schlewswig-Holstein, Kiel, Deutschland
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Lhermitte R, Le Daré B, Laval F, Lemaitre F, Troussier B, Morin MP, Vigneau C, Chemouny JM, Bacle A. A pharmacist-led intervention to improve kidney transplant recipient outcomes and identify patients at risk of highly variable trough tacrolimus levels: a cohort study. Eur J Hosp Pharm 2024; 31:314-320. [PMID: 36737230 PMCID: PMC11265551 DOI: 10.1136/ejhpharm-2022-003625] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2022] [Accepted: 01/23/2023] [Indexed: 02/05/2023] Open
Abstract
OBJECTIVES Given the positive impact of appropriate medication management on graft outcome and therefore of patient survival and graft function, the pharmacist's role in the kidney transplantation team has evolved over recent decades. The primary objective of this study was to determine whether pharmacist-led intervention after kidney transplantation is associated with a lower graft rejection rate and intra-patient variation in tacrolimus trough concentrations (Cmin). The study's secondary objective was to develop a questionnaire to identify patients at risk for highly variable Cmin. METHODS We retrospectively analysed kidney transplant recipients at Rennes University Hospital (France) between January 2013 and December 2020. Patients who received pharmacist-led education (intervention group, n=139) were compared with patients who did not (control group, n=131), according to graft survival at 1 year post-transplant, coefficient of variation (%CV) for the tacrolimus Cmin, age, sex, length of hospital stay post-transplantation, body mass index, and Charlson Comorbidity Index. In the intervention group, a questionnaire assessing patient knowledge was introduced to compare scores with the %CV. RESULTS In the intervention group, 1 year post-transplant graft survival was higher (95.7% vs 88.5%, p=0.0289) and patients had fewer variabilities in Cmin. The %CV was correlated with questionnaire scores (r=-0.9758, p<0.0001). CONCLUSIONS Pharmacist-led interventions may have contributed to improved graft survival and patient management of immunosuppressants. Because %CV correlates with the patient questionnaire score, its introduction could be useful in identifying kidney transplant patients who would benefit most from a pharmacist-led patient education.
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Affiliation(s)
| | - Brendan Le Daré
- Service Hospitalo-Universitaire de Pharmacie, Rennes, France
- NuMeCan, Rennes, France
| | - Florian Laval
- Service Hospitalo-Universitaire de Pharmacie, Rennes, France
| | - Florian Lemaitre
- Department of Clinical and Biological Pharmacology and Pharmacovigilance, Clinical Investigation Center CIC-P 1414, Rennes, France
| | | | | | - Cécile Vigneau
- Univ Rennes, CHU Rennes, INSERM, EHESP, Irset-UMR_S 1085, 35000, Rennes, France, Rennes, France
| | - Jonathan M Chemouny
- Univ Rennes, CHU Rennes, INSERM, EHESP, Irset-UMR_S 1085, 35000, Rennes, France, Rennes, France
| | - Astrid Bacle
- Service Hospitalo-Universitaire de Pharmacie, Rennes, France
- Univ Rennes, CHU Rennes, INSERM, EHESP, Irset-UMR_S 1085, 35000, Rennes, France, Rennes, France
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Jibai N, Koch A, Ulmer TF, Erdmann P, Koeck JA, Eisert A. Pharmaceutical Interventions for Inpatients with Liver Cirrhosis and Liver Transplantation: A Systematic Review of Experimental Studies. J Clin Med 2023; 12:7030. [PMID: 38002644 PMCID: PMC10671912 DOI: 10.3390/jcm12227030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2023] [Revised: 10/29/2023] [Accepted: 11/08/2023] [Indexed: 11/26/2023] Open
Abstract
Liver cirrhosis, which is considered one of the leading causes of death in the world, can lead to severe complications, and is often followed by a liver transplantation. These patients take an average of nine medications daily. If not managed adequately, it can be accompanied by serious drug-related problems. To reduce this risk, a clinical pharmacist may be included as part of the healthcare team to optimize medication therapy in this population. This study aimed to systematically identify the pharmaceutical interventions which reduced drug-related problems and improved medication therapy for adult hospitalized liver cirrhotic and liver transplant patients when compared to standard care. Three databases (PubMed, Embase, and CENTRAL) were systematically searched from the inception of each database to 25 October 2023, and interventional studies in the English language were included. The risk of bias was assessed according to RoB-I for the UBA study and RoB2 for the identified RCT. The detected interventions to reduce drug-related problems in liver cirrhotic and liver transplant patients were extracted and classified according to a "Hierarchy of Controls" model. Two studies from Germany and the USA met our inclusion criteria, respectively. In these studies, we identified two interventions that included education, expert consultation, and the monitoring of the immunosuppressive medications serum level. The main objective of the two included studies was improving patients' compliance through adherence. These pharmaceutical interventions identified were classified as administrative controls, which is one of the lowest levels in the "Hierarchy of Controls" with which to address a potential risk. Pharmaceutical interventions to optimize medication therapy were found to be rare in the examined population, and were limited to "administrative controls". These interventions were limited to transplant patients' education and the monitoring of the immunosuppressive medication serum levels. No interventional studies were found to have investigated pharmaceutical interventions in patients with liver cirrhosis. Especially regarding this patient group, future studies to reduce DRPs using pharmaceutical interventions are needed. This study received no external funding and its PROSPERO registration number is CRD42022309122.
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Affiliation(s)
- Nagham Jibai
- Hospital Pharmacy, RWTH Aachen University Hospital, 52074 Aachen, Germany; (N.J.); (P.E.)
| | - Alexander Koch
- Department of Internal Medicine III, RWTH Aachen University Hospital, 52074 Aachen, Germany;
| | - Tom Florian Ulmer
- Department of General, Visceral and Transplantation Surgery, RWTH Aachen University Hospital, 52074 Aachen, Germany;
| | - Pia Erdmann
- Hospital Pharmacy, RWTH Aachen University Hospital, 52074 Aachen, Germany; (N.J.); (P.E.)
| | | | - Albrecht Eisert
- Hospital Pharmacy, RWTH Aachen University Hospital, 52074 Aachen, Germany; (N.J.); (P.E.)
- Institute of Clinical Pharmacology, RWTH Aachen University Hospital, 52074 Aachen, Germany
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Serper M, Burdzy A, Schaubel DE, Mason R, Banerjee A, Goldberg DS, Martin EF, Mehta SJ, Russell LB, Cheung AC, Ladner DP, Yoshino Benavente J, Wolf MS. Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial. BMJ Open 2023; 13:e075172. [PMID: 37723108 PMCID: PMC10510935 DOI: 10.1136/bmjopen-2023-075172] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/28/2023] [Accepted: 08/25/2023] [Indexed: 09/20/2023] Open
Abstract
BACKGROUND AND AIMS Liver transplantation is a life-saving procedure for end-stage liver disease. However, post-transplant medication regimens are complex and non-adherence is common. Post-transplant medication non-adherence is associated with graft rejection, which can have long-term adverse consequences. Transplant centres are equipped with clinical staff that monitor patients post-transplant; however, digital health tools and proactive immunosuppression adherence monitoring has potential to improve outcomes. METHODS AND ANALYSIS This is a patient-randomised prospective clinical trial at three transplant centres in the Northeast, Midwest and South to investigate the effects of a remotely administered adherence programme compared with usual care. The programme monitors potential non-adherence largely levering text message prompts and phenotypes the nature of the non-adhere as cognitive, psychological, medical, social or economic. Additional reminders for medications, clinical appointments and routine self-management support are incorporated to promote adherence to the entire medical regimen. The primary study outcome is medication adherence via 24-hour recall; secondary outcomes include additional medication adherence (ASK-12 self-reported scale, regimen knowledge scales, tacrolimus values), quality of life, functional health status and clinical outcomes (eg, days hospitalised). Study implementation, acceptability, feasibility, costs and potential cost-effectiveness will also be evaluated. ETHICS AND DISSEMINATION The University of Pennsylvania Review Board has approved the study as the single IRB of record (protocol # 849575, V.1.4). Results will be published in peer-reviewed journals and summaries will be provided to study funders. TRIAL REGISTRATION NUMBER NCT05260268.
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Affiliation(s)
- Marina Serper
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Alexander Burdzy
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Douglas E Schaubel
- Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Richard Mason
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Arpita Banerjee
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - David S Goldberg
- Division of Digestive Health and Liver Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA
| | - Eric F Martin
- Division of Digestive Health and Liver Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA
| | - Shivan J Mehta
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Louise B Russell
- Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Amanda C Cheung
- Division of Gastroenterology and Hepatology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Daniela P Ladner
- Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Julia Yoshino Benavente
- Center for Applied Health Research on Aging, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Michael S Wolf
- Center for Applied Health Research on Aging, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
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de Zwaan M, Erim Y, Kröncke S, Vitinius F, Buchholz A, Nöhre M. Psychosocial Diagnosis and Treatment Before and After Organ Transplantation. DEUTSCHES ARZTEBLATT INTERNATIONAL 2023; 120:413-416. [PMID: 37101343 PMCID: PMC10437037 DOI: 10.3238/arztebl.m2023.0087] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/26/2023] [Revised: 01/06/2023] [Accepted: 03/29/2023] [Indexed: 04/28/2023]
Abstract
BACKGROUND This new clinical practice guideline concerns the psychosocial diagnosis and treatment of patients before and after organ transplantation. Its objective is to establish standards and to issue evidence-based recommendations that will help to optimize decision making in psychosocial diagnosis and treatment. METHODS For each key question, the literature was systematically searched in at least two databases (Medline, Ovid, Cochrane Library, and CENTRAL). The end date of each search was between August 2018 and November 2019, depending on the question. The literature search was also updated to capture recent publications, by using a selective approach. RESULTS Lack of adherence to immunosuppressant drugs can be expected in 25-30% of patients and increases the odds of organ loss after kidney transplantation (odds ratio 7.1). Psychosocial interventions can significantly improve adherence. Metaanalyses have shown that adherence was achieved 10-20% more frequently in the intervention group than in the control group. 13-40% of patients suffer from depression after transplantation; mortality in this group is 65% higher. The guideline group therefore recommends that experts in psychosomatic medicine, psychiatry, and psychology (mental health professionals) should be involved in patient care throughout the transplantation process. CONCLUSION The care of patients before and after organ transplantation should be multidisciplinary. Nonadherence rates and comorbid mental disorders are common and associated with poorer outcomes after transplantation. Interventions to improve adherence are effective, although the pertinent studies display marked heterogeneity and a high risk of bias.
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Affiliation(s)
- Martina de Zwaan
- Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover
| | - Yesim Erim
- Department of Psychosomatic Medicine and Psychotherapy, University Hospital of Erlangen, Friedrich-Alexander University Erlangen-Nürnberg
| | - Sylvia Kröncke
- Department of Medical Psychology at the Universitätsklinikum Hamburg-Eppendorf, Hamburg
| | - Frank Vitinius
- Department of Psychosomatics and Psychotherapy, University Hospital Cologne
| | - Angela Buchholz
- Department of Medical Psychology at the Universitätsklinikum Hamburg-Eppendorf, Hamburg
| | - Mariel Nöhre
- Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover
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Fuochi E, Anastasio L, Lynch EN, Campani C, Dragoni G, Milani S, Galli A, Innocenti T. Main factors influencing long-term outcomes of liver transplantation in 2022. World J Hepatol 2023; 15:321-352. [PMID: 37034235 PMCID: PMC10075010 DOI: 10.4254/wjh.v15.i3.321] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/18/2022] [Revised: 11/24/2022] [Accepted: 02/22/2023] [Indexed: 04/11/2023] Open
Abstract
Liver transplant (LT) outcomes have markedly improved in the recent decades, even if long-term morbidity and mortality are still considerable. Most of late deaths are independent from graft function and different comorbidities, including complications of metabolic syndrome and de novo neoplasms, seem to play a key role in determining long-term outcomes in LT recipients. This review discusses the main factors associated with late mortality and suggests possible strategies to improve long-term management and follow-up after liver transplantation. In particular, the reduction of drug toxicity, the use of tools to identify high-risk patients, and setting up a multidisciplinary team also for long-term management of LT recipients may further improve survival after liver transplantation.
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Affiliation(s)
- Elisa Fuochi
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
| | - Lorenzo Anastasio
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
| | - Erica Nicola Lynch
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
| | - Claudia Campani
- Department of Experimental and Clinical Medicine, University of Florence, Florence 50134, Italy
| | - Gabriele Dragoni
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
- Department of Medical Biotechnologies, University of Siena, Siena 53100, Italy
| | - Stefano Milani
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
| | - Andrea Galli
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
| | - Tommaso Innocenti
- Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence 50134, Italy
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Clinical pharmacy services are reimbursed in Germany: challenges of real world implementation remain. Int J Clin Pharm 2023; 45:245-249. [PMID: 36394784 PMCID: PMC9938802 DOI: 10.1007/s11096-022-01492-7] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2022] [Accepted: 09/19/2022] [Indexed: 11/18/2022]
Abstract
Over the last two decades, community pharmacy has experienced major changes as the role of pharmacists is evolving from a product to a service and a patient focus. As part of this change, new and innovative clinical pharmacy services aimed at improving medicines use and patient outcomes have been designed, both nationally and internationally. Since June 2022, five services are reimbursed by all statutory health insurance funds and private insurance companies in Germany: medication review for patients with polymedication; blood pressure control in hypertension; assuring proper inhalation techniques for patients receiving a new device or a device change; medication review including a follow-up for patients taking oral anticancer drugs or immunosuppressants post-transplantation. Beyond reimbursement, the upscaling and sustainable provision of these professional services are now the main challenges. Implementation research will provide important information for the further development of pharmaceutical care programs.
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Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev 2022; 9:CD012854. [PMID: 36094829 PMCID: PMC9466987 DOI: 10.1002/14651858.cd012854.pub2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/17/2023]
Abstract
BACKGROUND Non-adherence to immunosuppressant therapy is a significant concern following a solid organ transplant, given its association with graft failure. Adherence to immunosuppressant therapy is a modifiable patient behaviour, and different approaches to increasing adherence have emerged, including multi-component interventions. There has been limited exploration of the effectiveness of interventions to increase adherence to immunosuppressant therapy. OBJECTIVES This review aimed to look at the benefits and harms of using interventions for increasing adherence to immunosuppressant therapies in solid organ transplant recipients, including adults and children with a heart, lung, kidney, liver and pancreas transplant. SEARCH METHODS We searched the Cochrane Kidney and Transplant Register of Studies up to 14 October 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA All randomised controlled trials (RCTs), quasi-RCTs, and cluster RCTs examining interventions to increase immunosuppressant adherence following a solid organ transplant (heart, lung, kidney, liver, pancreas) were included. There were no restrictions on language or publication type. DATA COLLECTION AND ANALYSIS Two authors independently screened titles and abstracts of identified records, evaluated study quality and assessed the quality of the evidence using the GRADE approach. The risk of bias was assessed using the Cochrane tool. The ABC taxonomy for measuring medication adherence provided the analysis framework, and the primary outcomes were immunosuppressant medication initiation, implementation (taking adherence, dosing adherence, timing adherence, drug holidays) and persistence. Secondary outcomes were surrogate markers of adherence, including self-reported adherence, trough concentration levels of immunosuppressant medication, acute graft rejection, graft loss, death, hospital readmission and health-related quality of life (HRQoL). Meta-analysis was conducted where possible, and narrative synthesis was carried out for the remainder of the results. MAIN RESULTS Forty studies involving 3896 randomised participants (3718 adults and 178 adolescents) were included. Studies were heterogeneous in terms of the type of intervention and outcomes assessed. The majority of studies (80%) were conducted in kidney transplant recipients. Two studies examined paediatric solid organ transplant recipients. The risk of bias was generally high or unclear, leading to lower certainty in the results. Initiation of immunosuppression was not measured by the included studies. There is uncertain evidence of an association between immunosuppressant medication adherence interventions and the proportion of participants classified as adherent to taking immunosuppressant medication (4 studies, 445 participants: RR 1.09, 95% CI 0.95 to 1.20; I² = 78%). There was very marked heterogeneity in treatment effects between the four studies evaluating taking adherence, which may have been due to the different types of interventions used. There was evidence of increasing dosing adherence in the intervention group (8 studies, 713 participants: RR 1.14, 95% CI 1.03 to 1.26, I² = 61%). There was very marked heterogeneity in treatment effects between the eight studies evaluating dosing adherence, which may have been due to the different types of interventions used. It was uncertain if an intervention to increase immunosuppressant adherence had an effect on timing adherence or drug holidays. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on persistence. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on secondary outcomes. For self-reported adherence, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants classified as medically adherent to immunosuppressant therapy (9 studies, 755 participants: RR 1.21, 95% CI 0.99 to 1.49; I² = 74%; very low certainty evidence). Similarly, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the mean adherence score on self-reported adherence measures (5 studies, 471 participants: SMD 0.65, 95% CI -0.31 to 1.60; I² = 96%; very low certainty evidence). For immunosuppressant trough concentration levels, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants who reach target immunosuppressant trough concentration levels (4 studies, 348 participants: RR 0.98, 95% CI 0.68 to 1.40; I² = 40%; very low certainty evidence). It is uncertain whether an intervention to increase adherence to immunosuppressant medication may reduce hospitalisations (5 studies, 460 participants: RR 0.67, 95% CI 0.44 to 1.02; I² = 64%; low certainty evidence). There were limited, low certainty effects on patient-reported health outcomes such as HRQoL. There was no clear evidence to determine the effect of interventions on secondary outcomes, including acute graft rejection, graft loss and death. No harms from intervention participation were reported. AUTHORS' CONCLUSIONS Interventions to increase taking and dosing adherence to immunosuppressant therapy may be effective; however, our findings suggest that current evidence in support of interventions to increase adherence to immunosuppressant therapy is overall of low methodological quality, attributable to small sample sizes, and heterogeneity identified for the types of interventions. Twenty-four studies are currently ongoing or awaiting assessment (3248 proposed participants); therefore, it is possible that findings may change with the inclusion of these large ongoing studies in future updates.
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Affiliation(s)
- Lisa Mellon
- Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Frank Doyle
- Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Anne Hickey
- Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Kenneth D Ward
- School of Public Health, University of Memphis, Memphis, Tennessee, USA
| | - Declan G de Freitas
- Department of Nephrology and Kidney Transplantation, Beaumont Hospital, Dublin, Ireland
| | - P Aiden McCormick
- Irish Liver Transplant Unit, St Vincent's University Hospital, Dublin, Ireland
| | - Oisin O'Connell
- Irish National Lung and Heart Transplant Program, Mater Misericordiae University, Dublin, Ireland
| | - Peter Conlon
- Department of Nephrology and Kidney Transplantation, Beaumont Hospital, Dublin, Ireland
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10
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Bailey P, Vergis N, Allison M, Riddell A, Massey E. Psychosocial Evaluation of Candidates for Solid Organ Transplantation. Transplantation 2021; 105:e292-e302. [PMID: 33675318 DOI: 10.1097/tp.0000000000003732] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
Transplant candidates should undergo an assessment of their mental health, social support, lifestyle, and behaviors. The primary aims of this "psychosocial evaluation" are to ensure that transplantation is of benefit to life expectancy and quality of life, and to allow optimization of the candidate and transplant outcomes. The content of psychosocial evaluations is informed by evidence regarding pretransplant psychosocial predictors of transplant outcomes. This review summarizes the current literature on pretransplant psychosocial predictors of transplant outcomes across differing solid organ transplants and discusses the limitations of existing research. Pretransplant depression, substance misuse, and nonadherence are associated with poorer posttransplant outcomes. Depression, smoking, and high levels of prescription opioid use are associated with reduced posttransplant survival. Pretransplant nonadherence is associated with posttransplant rejection, and nonadherence may mediate the effects of other psychosocial variables such as substance misuse. There is evidence to suggest that social support is associated with likelihood of substance misuse relapse after transplantation, but there is a lack of consistent evidence for an association between social support and posttransplant adherence, rejection, or survival across all organ transplant types. Psychosocial evaluations should be undertaken by a trained individual and should comprise multiple consultations with the transplant candidate, family members, and healthcare professionals. Tools exist that can be useful for guiding and standardizing assessment, but research is needed to determine how well scores predict posttransplant outcomes. Few studies have evaluated interventions designed to improve psychosocial functioning specifically pretransplant. We highlight the challenges of carrying out such research and make recommendations regarding future work.
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Affiliation(s)
- Pippa Bailey
- Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
- Renal and Transplant Service, Southmead Hospital, North Bristol NHS Trust, Bristol, UK
| | - Nikhil Vergis
- Liver Services Department, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK
- Department of Metabolism Digestion and Reproduction, Imperial College London, UK
| | - Michael Allison
- Cambridge Liver Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Amy Riddell
- Renal and Transplant Service, Southmead Hospital, North Bristol NHS Trust, Bristol, UK
- University of Exeter Medical School, Exeter, UK
| | - Emma Massey
- Department of Internal Medicine, Nephrology and Transplantation, Erasmus Medical Center, Rotterdam, The Netherlands
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11
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Park L, Kim JH, Waldman G, Marks CR, Clark JE. Impact analysis of virtual ambulatory transplant pharmacists during COVID-19. JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY 2021; 4:978-987. [PMID: 34518815 PMCID: PMC8427059 DOI: 10.1002/jac5.1488] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2021] [Revised: 05/22/2021] [Accepted: 05/25/2021] [Indexed: 01/26/2023]
Abstract
INTRODUCTION During the coronavirus disease 2019 (COVID-19) pandemic, transplant centers were challenged to meet the demand for new telemedicine strategies. The ability of lung transplant providers (LTP) to conduct face-to-face clinic visits for high-risk immunocompromised patients, such as lung transplant recipients (LTR), was limited. Through the implementation of comprehensive medication management visits, pharmacists were able to assist LTP in the transition to telemedicine. METHODS A retrospective chart review of telephone encounters from cardiothoracic (CT) transplant pharmacists at our center from March to September 2020 was completed. LTR scheduled for clinic visits with LTP were called prior to the visit by CT transplant pharmacists who conducted medication list reviews, adherence assessments, and medication access assistance. Clinical recommendations were communicated directly to the LTP and documented in patient electronic medical records. The primary outcome was the number of pharmacist-driven clinical interventions. Secondary endpoints included the clinical severity and value of service of each intervention, percentage of accepted recommendations, patient cost savings interventions, prevention of adverse events, and avoidance of inappropriate doses. RESULTS From March to September 2020, the CT transplant pharmacists conducted 385 virtual visits on 157 LTR with a median of 20 minutes spent per visit. There were 891 total interventions made by CT transplant pharmacists, including 778 medication discrepancies identified. Over 60% of encounters demonstrated some form of medication error and over 55% of encounters exhibited value of pharmacy services. CONCLUSION Implementation of CT transplant pharmacist telehealth visits has potential for increased patient access to pharmacy care and improved accuracy of medication lists. When focusing on the severity of errors and value of services, most demonstrated a level of significance. Further investigation is needed to analyze the impact of this service on patient outcomes as well as cost-effectiveness.
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Affiliation(s)
- Lindsay Park
- Department of Pharmacy, Massachusetts General HospitalBostonMassachusettsUSA
| | - Ju Hee Kim
- Department of Pharmacy, Massachusetts General HospitalBostonMassachusettsUSA
| | - Georgina Waldman
- Department of Pharmacy, Massachusetts General HospitalBostonMassachusettsUSA
| | | | - Jacqueline E. Clark
- Department of Pharmacy, Massachusetts General HospitalBostonMassachusettsUSA
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12
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Deutsch-Link S, Weinberg EM, Bittermann T, McDougal M, Dhariwal A, Jones LS, Weinrieb RM, Banerjee AG, Addis S, Serper M. The Stanford Integrated Psychosocial Assessment for Transplant Is Associated With Outcomes Before and After Liver Transplantation. Liver Transpl 2021; 27:652-667. [PMID: 33320417 PMCID: PMC9531321 DOI: 10.1002/lt.25975] [Citation(s) in RCA: 35] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2020] [Revised: 11/27/2020] [Accepted: 12/02/2020] [Indexed: 12/07/2022]
Abstract
The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) is a standardized psychosocial evaluation tool used in liver transplantation (LT) evaluation. We assessed the impact of the SIPAT score and subdomains on transplant waitlisting decisions and post-LT outcomes including immunosuppression (IS) nonadherence, biopsy-proven rejection, andmortality/graft failure. We conducted a single-center observational cohort study of 1430 patients evaluated for LT. Patients were divided in 2 groups based on a SIPAT cutoff score of <21 or ≥21 (higher SIPAT scores indicate higher psychosocial risk). Regression models assessed relationships between total SIPAT score and domain scores and waitlisting decisions, IS nonadherence, allograft rejection, and death/graft failure. Elevated total SIPAT and SIPAT domain scores were associated not being added to the waitlist (total SIPAT core ≥21 adjusted odds ratio [aOR], 1.78 [95% confidence interval, CI, 1.36-2.33]; readiness score ≥5 aOR, 2.01 [95% CI, 1.36-2.76]; social support score ≥4aOR, 1.50 [95% CI, 1.15-1.94]; psychopathology score ≥7 aOR, 1.45 [95% CI, 1.07-1.94]; lifestyle/substance abuse score ≥12 aOR, 1.72 [95%CI, 1.23-2.39]) and were more likely to experience IS nonadherence as measured by the tacrolimus coefficient of variation (CoV) (total SIPAT score ≥21 aOR, 2.92 [95% CI, 1.69-5.03]; readiness score ≥5 aOR, 3.26 [95% CI, 1.63-6.52]; psychopathology score ≥7 aOR, 1.88 [95% CI, 1.00-3.50]; lifestyle substance abuse score ≥12 aOR, 3.03 [95% CI, 1.56-5.86]). SIPAT readinessscore ≥5 was associated with biopsy-proven allograft rejection (aOR, 2.66; 95% CI, 1.20-5.91). The SIPAT score was independently associated with LT listing decisions and IS nonadherence, and the readiness domain was associated with the risk of allograft rejection. These findings offer insights into higher risk recipients who require additional support before and aftertransplantation.
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Affiliation(s)
- Sasha Deutsch-Link
- Department of Gastroenterology & Hepatology, University of North Carolina–Chapel Hill, Chapel Hill, NC
| | - Ethan M. Weinberg
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Therese Bittermann
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Mackenzie McDougal
- Department of Medicine, Drexel University College of Medicine, Philadelphia, PA
| | - Aniket Dhariwal
- Department of Medicine, University of Pennsylvania, Philadelphia, PA
| | - Lauren S. Jones
- Philadelphia College of Osteopathic Medicine, Philadelphia, PA
| | - Robert M. Weinrieb
- Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Arpita G. Banerjee
- Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Senayish Addis
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Marina Serper
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA,Leonard Davis Institute of Health Economics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
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13
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Jones LS, Serper M. Medication non-adherence among liver transplant recipients. CURRENT HEPATOLOGY REPORTS 2020; 19:327-336. [PMID: 33816051 PMCID: PMC8011544 DOI: 10.1007/s11901-020-00545-7] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 10/07/2020] [Indexed: 01/30/2023]
Abstract
PURPOSE OF REVIEW We provide an overview of the recent evidence on the prevalence, risk factors, and consequences of medication non-adherence (NA) in liver transplant (LT) recipients. RECENT FINDINGS NA in LT is associated with socio-demographic and medication-related factors, low social support, and poor health literacy. Patient-reported adherence is one of the most common methods to measure NA using validated assessments; immunosuppression (IS) drug levels and electronic monitoring may also be used. Simplification of IS regimens such as the conversion from twice daily to once daily has been shown to be safe, effective, and improves adherence. Relatively few studies have prospectively investigated NA predictors or interventions to reduce NA in LT. SUMMARY Medication non-adherence is a multi-faceted issue that is common among LT recipients and associated with adverse outcomes. NA in LT recipients warrants further study as only a few interventions have been published focused on reducing NA in LT.
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Affiliation(s)
- Lauren S. Jones
- Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine
- Philadelphia College of Osteopathic Medicine, Philadelphia, PA
| | - Marina Serper
- Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine
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14
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Shi YX, Liu CX, Liu F, Zhang HM, Yu MM, Jin YH, Shang SM, Fu YX. Efficacy of Adherence-Enhancing Interventions for Immunosuppressive Therapy in Solid Organ Transplant Recipients: A Systematic Review and Meta-Analysis Based on Randomized Controlled Trials. Front Pharmacol 2020; 11:578887. [PMID: 33192520 PMCID: PMC7606769 DOI: 10.3389/fphar.2020.578887] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2020] [Accepted: 09/07/2020] [Indexed: 01/06/2023] Open
Abstract
Background Immunosuppressant non-adherence is a widespread problem among solid organ recipients. With the newly published clinical trials, the randomized controlled trials (RCTs) based systematic review of adherence-enhancing interventions on immunosuppressant adherence in solid organ recipients has not been completed. In this systematic review and meta-analysis, we compared the efficacy of adherence-enhancing interventions versus routine intervention, as performed with RCTs, on immunosuppressant adherence in solid organ transplantation recipients. Methods PubMed, Embase, Cochrane Library, CINAHL full text, and PsycINFO were searched from database inception to December 2019. This review was conducted following the PRISMA’s reporting guidelines and according to the principles recommended by Cochrane Handbook for Systematic Review. Results The search yielded 10,479 articles. A total of 27 articles (26 studies) with 715 participants were included in our analysis. Results from the meta-analysis revealed that as compared with that of the routine intervention group, the rates of overall adherence, dosing adherence, and timing adherence were significantly increased within the adherence-enhancing intervention group, with the pooled risk ratio (RR) of overall adherence = 1.17, [95% confidence interval (CI): 1.07 to 1.28; p = 0.0006]; RR of dosing adherence = 1.21 (95% CI: 1.08 to 1.36, p = 0.001); RR of timing adherence = 1.16 (95% CI: 1.03 to 1.29, p = 0.01). There was a significantly increased adherence score in the adherence-enhancing intervention group; however, no statistical significance on the immunosuppressant blood concentration was found between the two study groups. Results obtained from a subgroup analysis shown interventions led by a multidisciplinary team, both the assessment time at 6 months and 12 months demonstrated a significantly increased adherence rate in the intervention group compared with the control group. Conclusions The findings of this report indicate that clinicians (doctors and nurses) should maintain a long-term intervention protocol to ensure immunosuppressant adherence within solid organ transplant recipients. To accomplish this goal, we recommend a multidisciplinary team-led, comprehensive intervention approach combined with mobile health monitoring for the administration of an effective immunosuppressive therapy regimen.
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Affiliation(s)
- Yue-Xian Shi
- School of Nursing, Peking University, Beijing, China
| | - Chun-Xia Liu
- Department of Urinary Surgery, Peking University Third Hospital, Beijing, China
| | - Fei Liu
- School of Public Health, Peking University, Beijing, China
| | - Hai-Ming Zhang
- Liver Transplantation Center, Clinical Center for Pediatric Liver Transplantation, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Ming-Ming Yu
- School of Nursing, Peking University, Beijing, China
| | - Yin-Hui Jin
- Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.,Center for Evidence-Based and Translational Medicine, Wuhan University, Wuhan, China
| | | | - Ying-Xin Fu
- Department of Kidney Transplantation, Tianjin First Center Hospital, Tianjin, China
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15
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Russell CL, Hathaway D, Remy LM, Aholt D, Clark D, Miller C, Ashbaugh C, Wakefield M, Ye S, Staggs VS, Ellis RJ, Goggin K. Improving medication adherence and outcomes in adult kidney transplant patients using a personal systems approach: SystemCHANGE™ results of the MAGIC randomized clinical trial. Am J Transplant 2020; 20:125-136. [PMID: 31291507 PMCID: PMC7179766 DOI: 10.1111/ajt.15528] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2018] [Revised: 06/27/2019] [Accepted: 07/07/2019] [Indexed: 01/25/2023]
Abstract
This study determined if a SystemCHANGE™ intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and subsequent 6-month (no intervention) maintenance phase. The SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. Eighty-nine patients (average age 51.8 years, 58% male, 61% African American) completed the 6-month intervention phase. Using an intent-to-treat analysis, at 6 months, medication adherence for SystemCHANGE™ (median 0.91, IQR 0.76-0.96) and attention control (median 0.67, IQR 0.52-0.72) patients differed markedly (difference in medians 0.24, 95% CI 0.13-0.30, P < .001). At the conclusion of the subsequent 6-month maintenance phase, the gap between medication adherence for SystemCHANGE™ (median 0.77, IQR 0.56-0.94) and attention control (median 0.60, IQR 0.44-0.73) patients remained large (difference in medians 0.17, 95% CI 0.06-0.33, P = .004). SystemCHANGE™ patients evidenced lower mean creatinine and BUN at 12 months and more infections at 6 and 12 months. This first fully powered RCT testing SystemCHANGE™ to improve and maintain medication adherence in kidney transplant recipients demonstrated large, clinically meaningful improvements in medication adherence. Clinical Trial Registration: NCT02416479.
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Affiliation(s)
- Cynthia L. Russell
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Donna Hathaway
- College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Laura M. Remy
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Dana Aholt
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Debra Clark
- College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Courtney Miller
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Catherine Ashbaugh
- University of Missouri Renal Transplant Program, University of Missouri Health Care, Columbia, Missouri
| | - Mark Wakefield
- University of Missouri Renal Transplant Program, University of Missouri Health Care, Columbia, Missouri
| | - Sangbeak Ye
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Vincent S. Staggs
- Health Services & Outcomes Research, Children’s Mercy Kansas City, Kansas City, Missouri
| | - Rebecca J. Ellis
- Indiana University School of Nursing, Indiana University-Purdue University, Indianapolis, Indiana
| | - Kathy Goggin
- Health Services & Outcomes Research, Children’s Mercy Kansas City, Kansas City, Missouri
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Maldonado AQ, Hall RC, Pilch NA, Ensor CR, Anders S, Gilarde JA, Tichy EM. ASHP Guidelines on Pharmacy Services in Solid Organ Transplantation. Am J Health Syst Pharm 2019; 77:222-232. [DOI: 10.1093/ajhp/zxz291] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Affiliation(s)
| | - Reed C Hall
- University Health System, San Antonio, TX
- Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, Austin, TX
| | | | | | - Stephanie Anders
- Transplant Pharmacy Services, Ochsner Clinic Foundation, New Orleans, LA
| | | | - Eric M Tichy
- Supply Chain Management, Mayo Clinic, Rochester, MN
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17
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Tsapepas DS, Salerno D, Jandovitz N, Hammad S, Jordan P, Mohan S, Hardy M, Kotchoubey H, Vawdrey D, Fleischut PM. Using technology to enhance medication regimen education after solid organ transplantation. Am J Health Syst Pharm 2019; 75:1930-1937. [PMID: 30463868 DOI: 10.2146/ajhp170799] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
PURPOSE The design and implementation of a tool that combines clinical teaching with cutting-edge, simplified technology for providing medication education to solid organ transplant (SOT) recipients are described. METHODS In a retrospective study of adults who received kidney transplants from February 2015 through May 2017, patients were educated about their medications using a tablet computer application, Medication Regimen Education (MRxEd), that presented concise videos describing the name, indication, dose, adverse effects, and associated interactions of all medications received, as well as special considerations applicable to each agent. Assessment questions were used to reinforce key concepts and identify knowledge gaps. RESULTS The digital educational intervention was provided to 282 kidney transplant recipients. Patients were predominantly white (48%) and/or male (63%), with a median age of 51 years (interquartile range, 37-61 years). Patients came from a variety of education backgrounds. Most patients (81%) were educated on dual maintenance immunosuppression (with tacrolimus and mycophenolate) and 3 infection prophylaxis agents (nystatin, sulfamethoxazole-trimethoprim, and valganciclovir). Most patients (90%) correctly answered questions related to medication indications, dosing, and special rules, but many (61%) had difficulty correctly answering questions about adverse effects. CONCLUSION An innovative approach for interactive and engaging medication teaching with the MRxEd application enhanced the education process for SOT recipients.
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Affiliation(s)
- Demetra S Tsapepas
- NewYork-Presbyterian Hospital, New York, NY, and Department of Surgery, Columbia University, New York, NY
| | | | | | | | | | - Sumit Mohan
- NewYork-Presbyterian Hospital, New York, NY, and Department of Medicine, Columbia University, New York, NY
| | - Mark Hardy
- Department of Surgery, Columbia University, New York, NY
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Tohidinezhad F, Aliakbarian M, Abu-Hanna A, Eslami S. Development and Psychometric Testing of Liver Transplant Therapeutic Adherence Questionnaire in a Triphasic Mixed-Method Study. Prog Transplant 2019; 29:122-128. [PMID: 30961420 DOI: 10.1177/1526924819835824] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
INTRODUCTION Due to the high nonadherence rate to posttransplant regimen and medical indications among liver transplant recipients, systematic patient-centered interventions are needed to improve the medium- and long-term graft and patient survival outcomes. OBJECTIVE The aim of this study was to develop and test the psychometric properties of Liver Transplant Therapeutic Adherence Questionnaire. DESIGN A mixed-method instrument design was conducted in 3 phases: (1) initial item collection was generated by inductive content analysis on internationally available resources, (2) item screening was carried out by a 3-member committee and 25 domain experts including nurses and physicians aiming to establish content validity, and (3) data were collected from 247 liver transplant recipients in May 2016 for psychometric testing. RESULTS A total of 221 knowledge statements were extracted as potential adherence assessment items. The qualitative screening phase resulted in top 35 important items. The second screening phase was performed quantitatively by 25 experts (n = 14 nurses, n = 7 gastroenterologists and hepatologists, and n = 4 transplant surgeons). A total of 16 items were associated with statistically significant content validity ratio values (≥0.37) to be included in the final questionnaire. Exploratory factor analysis revealed a distinct 4-factor structure that was labeled as: daily activities (α = .93), immunization (α = .93), nutrition (α = .92), and major complications (α = .79). DISCUSSION Our results reveal evidence of acceptable reliability and validity for Liver Transplant Therapeutic Adherence Questionnaire. This instrument makes it possible to measure recipients' therapeutic adherence in both domains of research and practice.
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Affiliation(s)
- Fariba Tohidinezhad
- 1 Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Mohsen Aliakbarian
- 2 Surgical Oncology Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Ameen Abu-Hanna
- 3 Department of Medical Informatics, University of Amsterdam, Amsterdam, the Netherlands
| | - Saeid Eslami
- 4 Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
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Tan PS, Muthiah MD, Koh T, Teoh YL, Chan A, Kow A, Zheng Q, Kwon CHD, Lee GH, Lesmana CRA, de Villa V, Fung J, Lim K. Asian Liver Transplant Network Clinical Guidelines on Immunosuppression in Liver Transplantation. Transplantation 2019; 103:470-480. [PMID: 30422953 DOI: 10.1097/tp.0000000000002532] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Most management guidelines and much of the available clinical trial evidence for immunosuppressants in liver transplantation (LT) pertain to Western practice. While evidence from Western studies may not translate to Asian settings, there is a paucity of Asian randomized controlled trials of immunosuppression in liver recipients. Nonetheless, there are notable differences in the indications and procedures for LT between Western and Asian settings. The Asian Liver Transplant Network held its inaugural meeting in Singapore in November 2016 and aimed to provide an Asian perspective on aspects of immunosuppression following LT. Because of their importance to outcome following LT, the meeting focused on (1) reducing the impact of renal toxicity, (2) hepatocellular carcinoma recurrence, and (3) nonadherence with immunosuppressant therapy.
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Affiliation(s)
- Poh Seng Tan
- Division of Gastroenterology and Hepatology, National University Hospital, National University Health System, Singapore
- National University Centre for Organ Transplantation, National University Hospital, National University Health System, Singapore
| | - Mark D Muthiah
- Division of Gastroenterology and Hepatology, National University Hospital, National University Health System, Singapore
- National University Centre for Organ Transplantation, National University Hospital, National University Health System, Singapore
| | - Tsingyi Koh
- Department of Pharmacy, National University Hospital, National University Health System, Singapore
| | | | - Albert Chan
- Division of Hepatobiliary and Pancreatic Surgery, and Liver Transplantation, Department of Surgery, Queen Mary Hospital, Hong Kong
| | - Alfred Kow
- National University Centre for Organ Transplantation, National University Hospital, National University Health System, Singapore
- Division of Hepatopancreatobiliary Surgery and Division of Liver Transplantation, Department of Surgery, University Surgical Cluster, National University Health System, National University of Singapore, Singapore
| | - Qishi Zheng
- Singapore Clinical Research Institute, Singapore
| | - Choon Hyuck David Kwon
- Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
| | - Guan Huei Lee
- Division of Gastroenterology and Hepatology, National University Hospital, National University Health System, Singapore
- National University Centre for Organ Transplantation, National University Hospital, National University Health System, Singapore
| | - Cosmas Rinaldi A Lesmana
- Hepatobiliary Division, Department of Internal Medicine, Cipto Mangunkusumo Hospital, Universitas Indonesia, Jakarta, Indonesia
- Digestive Disease & GI Oncology Center, Medistra Hospital, Jakarta, Indonesia
| | - Vanessa de Villa
- Department of Surgery and Center for Liver Disease Management and Transplantation, The Medical City, Pasig City, Philippines
| | - James Fung
- Department of Medicine, Queen Mary Hospital, Hong Kong
| | - Kieron Lim
- Division of Gastroenterology and Hepatology, National University Hospital, National University Health System, Singapore
- National University Centre for Organ Transplantation, National University Hospital, National University Health System, Singapore
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20
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Schulz M, Klopp-Schulze L, Keilhack S, Meyer S, Botermann L, Kloft C. Adherence to tamoxifen in breast cancer patients: What role does the pharmacist play in German primary care? Can Pharm J (Ott) 2018; 152:28-34. [PMID: 30719195 DOI: 10.1177/1715163518815720] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/12/2023]
Affiliation(s)
- Madlene Schulz
- Department of Clinical Pharmacy and Biochemistry (all authors), Institute of Pharmacy, Freie Universitaet Berlin
| | - Lena Klopp-Schulze
- Department of Clinical Pharmacy and Biochemistry (all authors), Institute of Pharmacy, Freie Universitaet Berlin
| | - Stefanie Keilhack
- Department of Clinical Pharmacy and Biochemistry (all authors), Institute of Pharmacy, Freie Universitaet Berlin
| | - Sandra Meyer
- Department of Clinical Pharmacy and Biochemistry (all authors), Institute of Pharmacy, Freie Universitaet Berlin
| | - Lea Botermann
- Department of Clinical Pharmacy and Biochemistry (all authors), Institute of Pharmacy, Freie Universitaet Berlin
| | - Charlotte Kloft
- Department of Clinical Pharmacy and Biochemistry (all authors), Institute of Pharmacy, Freie Universitaet Berlin
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21
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Shneider C, Dunphy C, Shemesh E, Annunziato RA. Assessment and Treatment of Nonadherence in Transplant Recipients. Gastroenterol Clin North Am 2018; 47:939-948. [PMID: 30337042 DOI: 10.1016/j.gtc.2018.07.015] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
Stable intake of an immunosuppressant medication regimen is essential for posttransplant survival in the vast majority of cases. And yet, many patients are nonadherent (do not take their medications as prescribed), and suffer consequences ranging from rejection to morbidity and mortality. We review the evidence related to monitoring of adherence to medications, and intervention strategies. Our aim is to provide a baseline from which readers may approach behavioral aspects of posttransplant care. This review may also help readers in designing clinical programs for routine monitoring of adherence, and inform the choice of intervention when adherence falls below a certain threshold.
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Affiliation(s)
- Caitlin Shneider
- Center for Translational Science, Children's National Medical Center, 111 Michigan Avenue Northwest, 5th Floor Main, Suite 5500, Office 5533, Washington, DC 20010, USA
| | - Claire Dunphy
- Clinical Psychology, Department of Psychology, Fordham University, 441 East Fordham Road, Dealy Hall, Bronx, NY 10458, USA
| | - Eyal Shemesh
- Division of Behavioral and Developmental Health, The Department of Pediatrics, Kravis Children's Hospital, Icahn School of Medicine at Mount Sinai, Box 1198, 1 Gustave L Levy Place, New York, NY 10029, USA.
| | - Rachel A Annunziato
- Psychology, Fordham College at Rose Hill, Fordham University, 441 East Fordham Road, Dealy Hall, Bronx, NY 10458, USA
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22
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Xu XF, Feng YT, Tian YF, Wang HY. Pharmaceutical Care in Kidney Transplant Recipients: Behavioral and Physiologic Outcomes at 12 Months. Transplant Proc 2018; 50:2451-2456. [PMID: 30316377 DOI: 10.1016/j.transproceed.2018.04.049] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/04/2018] [Revised: 04/06/2018] [Accepted: 04/24/2018] [Indexed: 10/17/2022]
Abstract
BACKGROUND A variety of complex drug regimens are offered to kidney transplant recipients after transplantation. This study aimed to evaluate the behavioral and physiological outcomes of pharmaceutical care in this population. METHODS A cross-sectional prospective study was conducted, which collected and categorized kidney transplant recipients according to pharmaceutical care. In the IR group, patients had received irregular pharmaceutical care after transplantation, and in the RE group, patients had received regular intervention. Intervention included face-to-face interview, checkup for laboratory examinations, discovery of drug-related problems, and pharmaceutical consultation. Baseline knowledge for self-care was tested for patients in both groups. Correct concepts and medication guidance were consistently provided to enable patients to understand the importance of rejection prevention and knowledge for medication and renal care after transplantation. After 12 months, the same test was used to evaluate the outcomes for pharmaceutical care and a satisfaction questionnaire was used to assess for pharmacy service. RESULTS The study results revealed that patients in the RE group possessed better knowledge for self-care (P < .001); however, the differences at 12 months became insignificant (P = .72) after patients in the IR group had also received routine pharmaceutical care. Besides, serum creatinine level of the RE patients was stable without significant variation (P = .93), but it demonstrated a rising trend in IR patients (P < .01). Patients were greatly satisfactory with the intervention. CONCLUSIONS A consistent post-transplantation pharmaceutical care service is effective to substantially improve knowledge of post-transplantation self-care. Pharmaceutical care should be started as early as possible during the pre-transplant period and continue in a long-term follow-up.
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Affiliation(s)
- X F Xu
- Department of Pharmacy, Shanghai Second People's Hospital, Shanghai, China
| | - Y T Feng
- Graduate Institute of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung, Taiwan, ROC
| | - Y F Tian
- Department of General Surgery, Chi-Mei Medical Center, Tainan, Taiwan, ROC
| | - H Y Wang
- Department of Pharmacy, Chi-Mei Medical Center, Tainan, Taiwan, ROC; School of Pharmacy, Chia Nan University of Pharmacy & Science, Tainan, Taiwan, ROC.
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23
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Sam S, Guérin A, Rieutord A, Belaiche S, Bussières JF. Roles and Impacts of the Transplant Pharmacist: A Systematic Review. Can J Hosp Pharm 2018; 71:324-337. [PMID: 30401999 PMCID: PMC6209508] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
BACKGROUND Pharmacists have been involved in the care of transplant recipients for several decades, and a growing body of literature shows the beneficial effects of clinical pharmacist care on important outcomes for these patients. OBJECTIVES The primary objective was to describe the roles and impacts of pharmacists in a solid organ transplant setting. The secondary objective was to describe and rate the pharmacists' interventions. DATA SOURCES Three databases-PubMed, Embase, and Evidence-Based Medicine Reviews-were searched from January 1, 1990, to June 16, 2015. STUDY SELECTION AND DATA EXTRACTION All studies addressing the roles of pharmacists and the impacts of clinical pharmacy services on the care of solid organ transplant recipients were considered. Only studies providing a statistical analysis were included. Design, setting, sample size, patient characteristics, pharmacists' interventions, study bias, and outcomes were extracted for analysis. DATA SYNTHESIS Four randomized controlled trials, 4 cohort studies, 3 pre-post studies, and 1 quasi-randomized controlled trial were included in the review, representing a total of 1837 patients. Of the 12 studies included, 8 specifically focused on renal transplant, and 1 each focused on liver, lung, abdominal organ, and general solid organ transplant. The pivotal pharmacist activities leading to the main patient outcomes were medication counselling (n = 8 studies), medication reconciliation (n = 5), and reviewing and optimizing drug therapy (n = 3). Improvements to medication adherence (n = 6 studies), morbidity (n = 4), costs (n = 2), and medication errors (n = 2) were reported. CONCLUSION Currently available evidence suggests that pharmacists can improve patient outcomes in the solid organ transplant setting. Adherence, morbidity, costs, and medication errors were identified as the main outcomes that were improved by pharmaceutical interventions. Transplant programs need to invest more in this resource.
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Affiliation(s)
- Sébastien Sam
- , PharmD, is with the Pharmacy Practice Research Unit, Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec
| | - Aurélie Guérin
- , PharmD, is with the Pharmacy Practice Research Unit, Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec
| | - André Rieutord
- , PharmD, PhD, is with the Pharmacy Department, Hôpital Antoine-Bédère, Clamart, France
| | - Stéphanie Belaiche
- , PharmD, is with the Pharmacy Department, Centre hospitalier universitaire Lille, Lille, France
| | - Jean-François Bussières
- , BPharm, MSc, MBA, FCSHP, is with the Pharmacy Practice Research Unit, Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, and the Faculty of Pharmacy, Université de Montréal, Montréal, Quebec
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24
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Khorassani F, Tellier S, Tsapepas D. Pharmacist's Role in Improving Medication Adherence in Transplant Recipients With Comorbid Psychiatric Disorders. J Pharm Pract 2018; 32:568-578. [PMID: 29554846 DOI: 10.1177/0897190018764074] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
Abstract
Medication nonadherence rates are high in both the transplant and psychiatric populations. The consequence of medication nonadherence posttransplant is graft rejection and psychiatric decompensation, highlighting the importance of optimizing adherence to medication regimens. Pharmacists may work with transplant patients with psychiatric comorbidity to improve medication adherence through identifying patient-specific barriers and recommending an appropriate intervention. Multiple evidence-based practices for improving nonadherence have been detailed in the transplant and psychiatric population. Medication adherence aids, medication management, patient education, and motivational interviewing are all strategies that may be used to improve adherence. Selecting which interventions to make will be based on the reasons for a patient's nonadherence. Most patients benefit from medication management, patient education, and medication adherence aids. Selection of medication adherence aids may be based on patient demographics, technology literacy, and preference. Motivational interviewing may be considered in patients with intentional nonadherence relating to a lack of insight into their illness or the importance of taking medication. Pharmacists may promote adherence and potentially improve patient outcomes in transplant recipients with comorbid psychiatric disorders through assisting patients with designing a tailored medication adherence plan.
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Affiliation(s)
- Farah Khorassani
- Department of Clinical Health Professions, St John's University College of Pharmacy and Health Sciences, Queens, NY, USA.,Department of Pharmacy, Bellevue Hospital Center, New York, NY, USA
| | - Shannon Tellier
- Department of Pharmacy Practice and Clinical Sciences, Stony Brook University School of Pharmacy and Pharmaceutical Sciences, Stony Brook, NY, USA
| | - Demetra Tsapepas
- Department of Transplantation Surgery, Columbia University Medical Center, NewYork-Presbyterian Hospital, New York, NY, USA
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25
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Hartono JL, Koh T, Lee GH, Tan PS, Muthiah M, Aw MM, Madhavan K, Kow A, Lim KB. Predictors of Non-adherence to Immunosuppressive Therapy in Asian Liver Transplant Recipients. Transplant Proc 2018; 49:1419-1424. [PMID: 28736016 DOI: 10.1016/j.transproceed.2017.02.049] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2017] [Accepted: 02/23/2017] [Indexed: 10/19/2022]
Abstract
BACKGROUND Adherence to immunosuppressive medications has been shown to affect post-transplant outcomes. We aimed to determine the level of adherence to immunosuppressive therapy in liver transplant (LT) recipients and to elucidate factors associated with it, as well as patient preferences on the dosing schedule. METHODS LT recipients were recruited during transplant clinic follow-up. A validated Morisky 8-item questionnaire was completed by patients to assess their adherence to immunosuppressive therapy. Adherence was determined by the sum of the responses to the questionnaire. Low, medium, and high adherence were defined by a Morisky score of >2, 1 to 2, and 0, respectively. Data on the patient's socio-economic and clinical background, dosing schedule of immunosuppressant medications, and patient preferences were included in the questionnaire. RESULTS A total of 107 LT recipients were approached and 75 completed the questionnaire. The majority of patients (48/74, 64.9%) preferred a once-daily medication regimen. The proportion of high adherence was 24/75 (32.0%), medium adherence was 51/75 (42.7%), and low adherence was 19/75 (25.3%). Multivariate analysis showed younger age and post-transplant duration >5 years as independent predictors for low adherence. Among low-adherence patients, 16/19 (84.2%) patients were on a twice-daily regimen, and, of these, 14/16 (87.5%) preferred their medications to be reduced to once daily. CONCLUSIONS A significant proportion (68%) of LT recipients had low to moderate adherence to medications, with younger age and longer post-transplant duration of >5 years as independent predictors. Early identification of at-risk patients is essential to allow implementation of measures to improve adherence. Simplifying medication regimens to once daily is a potential way to improve adherence.
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Affiliation(s)
- J L Hartono
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Gastroenterology and Hepatology, National University Health System, Singapore
| | - T Koh
- Department of Pharmacy, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore
| | - G H Lee
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Gastroenterology and Hepatology, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore
| | - P S Tan
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Gastroenterology and Hepatology, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore
| | - M Muthiah
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Gastroenterology and Hepatology, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore
| | - M M Aw
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Department of Pediatrics, Khoo Teck Puat-National University Children's Medical Institute, National University Health System, Singapore
| | - K Madhavan
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Hepatobiliary and Pancreatic Surgery, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore
| | - A Kow
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Hepatobiliary and Pancreatic Surgery, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore
| | - K B Lim
- Yong Yoo Lin School of Medicine, National University of Singapore, Singapore; Division of Gastroenterology and Hepatology, National University Health System, Singapore; National University Centre for Organ Transplantation, National University Health System, Singapore.
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26
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Russell CL, Miller C, Remy LM, Wessol JL, Andrews AM, Aholt D, Clark D, Hardinger K, O'Brien T, Hathaway D, Goggin K. Improvement of Immunosuppressive Medication Adherence Using a SystemCHANGE Intervention: Case Study of an Older Adult Kidney Transplant Recipient. Nephrol Nurs J 2018; 45:171-223. [PMID: 30303638 PMCID: PMC6456040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
This article reports a case study of an older adult kidney transplant recipient with poor medication adherence enrolled in an innovative six-month SystemCHANGE intervention that seeks to systematically improve medication adherence by identifying and shaping routines, involving others in routines, and using medication-taking feedback through small, patient-led experiments. Medication adherence increased immediately and was sustained throughout the intervention and maintenance phases. This is the first case study to demonstrate effectiveness of the SystemCHANGE intervention for promoting medication adherence in a kidney transplant recipient. The intervention improved the timing of doses by linking them to a regularly occurring behavior and providing feedback. The SystemCHANGE intervention represents a systems-thinking approach for both provider and patients, and gives healthcare providers the tools needed to assist patients in using habits and routines, and feedback to improve medication taking and timing.
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Affiliation(s)
- Cynthia L Russell
- Professor, University of Missouri - Kansas City, School of Nursing and Health Studies, Kansas City, MO
| | - Courtney Miller
- Research Assistant, University of Missouri - Kansas City, School of Nursing and Health Studies, Kansas City, MO
| | - Laura M Remy
- Research Assistant, University of Missouri - Kansas City, School of Nursing and Health Studies, Kansas City, MO
| | - Jennifer L Wessol
- PhD Student and Jonas Nurse Leader Scholar 2016-2018, University of Missouri - Kansas City, School of Nursing and Health Studies, Kansas City, MO
| | - Angela M Andrews
- PhD Student, University of Missouri - Kansas City, School of Nursing and Health Studies, Kansas City, MO
| | - Dana Aholt
- Research Assistant, University of Missouri - Kansas City, School of Nursing and Health Studies, Kansas City, MO
- Member of ANNA's Central Missouri Chapter
| | - Debra Clark
- Research Nurse Coordinator, University of Tennessee Health Science Center, College of Nursing, Memphis, TN
| | - Karen Hardinger
- Assistant Professor, Ohio State University, Columbus, OH
- Member of ANNA's Bluff city Chapter
| | - Tara O'Brien
- Assistant Professor, Ohio State University, Columbus, OH
- Member of ANNA's Bluff city Chapter
| | - Donna Hathaway
- University Distinguished Professor, University of Tennessee Health Science Center, College of Nursing, Memphis, TN
- member of ANNA's Bluff City Chapter
| | - Kathy Goggin
- Ernest L. Glasscock Chair of Pediatric Education and Research, Associate Chair for Research, Department of Pediatrics, Deputy Director, Children's Research Institute, Director, Health Services and Outcomes Research, Children's Mercy Hospital
- Professor of Medicine and Pharmacy, University of Missouri - Kansas City, School of Medicine Pharmacy, Kansas City, MO
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27
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Ettenger R, Albrecht R, Alloway R, Belen O, Cavaillé-Coll MW, Chisholm-Burns MA, Dew MA, Fitzsimmons WE, Nickerson P, Thompson G, Vaidya P. Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients. Am J Transplant 2018; 18:564-573. [PMID: 29288623 DOI: 10.1111/ajt.14635] [Citation(s) in RCA: 36] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2017] [Revised: 11/16/2017] [Accepted: 12/18/2017] [Indexed: 01/25/2023]
Abstract
The Food and Drug Administration (FDA) held a public meeting and scientific workshop in September 2016 to obtain perspectives from solid organ transplant recipients, family caregivers, and other patient representatives. The morning sessions focused on the impact of organ transplantation on patients' daily lives and the spectrum of activities undertaken to maintain grafts. Participants described the physical, emotional, and social impacts of their transplant on daily life. They also discussed their posttransplant treatment regimens, including the most burdensome side effects and their hopes for future treatment. The afternoon scientific session consisted of presentations on prevalence and risk factors for medication nonadherence after transplantation in adults and children, and interventions to manage it. As new modalities of Immunosuppressive Drug Therapy are being developed, the patient perceptions and input must play larger roles if organ transplantation is to be truly successful.
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Affiliation(s)
- Robert Ettenger
- Department of Pediatrics, UCLA Mattel Children's Hospital, Los Angeles, CA, USA
| | - Renata Albrecht
- Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Rita Alloway
- Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Ozlem Belen
- Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Marc W Cavaillé-Coll
- Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Marie A Chisholm-Burns
- Colleges of Pharmacy and Medicine, University of Tennessee Health Science Center, Memphis, TN, USA
| | - Mary Amanda Dew
- Departments of Psychiatry, Psychology, Epidemiology, Biostatistics, and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA, USA
| | | | - Peter Nickerson
- Department of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Graham Thompson
- Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Pujita Vaidya
- Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
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28
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Duncan S, Annunziato RA, Dunphy C, LaPointe Rudow D, Shneider BL, Shemesh E. A systematic review of immunosuppressant adherence interventions in transplant recipients: Decoding the streetlight effect. Pediatr Transplant 2018; 22:10.1111/petr.13086. [PMID: 29218760 PMCID: PMC5811374 DOI: 10.1111/petr.13086] [Citation(s) in RCA: 43] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/23/2017] [Indexed: 12/23/2022]
Abstract
Non-adherence to immunosuppressant medications is an important risk factor for graft dysfunction. To evaluate the effectiveness of adherence-enhancing interventions, we reviewed adherence intervention studies in solid organ transplant recipients (all ages). Using the following databases: PsycINFO, PubMed, Scopus, and ScienceDirect, we identified 41 eligible studies. Only three non-randomized trials showed a possible positive effect on objective indicators of transplant outcomes (such as rejection, liver enzyme levels, kidney function). None of the 21 RCTs showed an improvement in transplant outcomes. Three studies showed a higher rate of adverse events in the intervention group as compared with controls, although this may be related to ascertainment bias. Improvement in adherence as measured indirectly (eg, with electronic monitoring devices) was not aligned with effects on transplant outcomes. We conclude that adherence interventions, to date, have largely been ineffective in improving transplant outcomes. To improve this track record, intervention efforts may wish to concentrate on non-adherent patients (rather than use convenience sampling, which excludes many of the patients who need the intervention), use direct measures of adherence to guide the interventions, and employ strategies that are intensive and yet engaging enough to ensure that non-adherent patients are able to participate.
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Affiliation(s)
- S Duncan
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - R A Annunziato
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - C Dunphy
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - D LaPointe Rudow
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
| | - B L Shneider
- Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA
| | - E Shemesh
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
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29
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Serper M, Reese PP, Patzer RR, Levitsky J, Wolf MS. The prevalence, risk factors, and outcomes of medication trade-offs in kidney and liver transplant recipients: a pilot study. Transpl Int 2017; 31:870-879. [PMID: 29178601 DOI: 10.1111/tri.13098] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2017] [Revised: 07/03/2017] [Accepted: 11/19/2017] [Indexed: 11/30/2022]
Abstract
High out-of-pocket medication costs negatively impact adherence in transplantation. We evaluated the association of "medication trade-offs"-defined as choosing to spend money on other expenses over medications-with medication nonadherence and transplant outcomes. From 2011 to 2012, we performed a prospective study of 201 transplanted recipients (n = 103 liver, n = 98 kidney and) at two large US transplant centers. Structured interviews assessed socio-demographics, medication adherence, and medication trade-offs. Multivariable models assessing risk factors for medications trade-offs and the association between medications trade-offs and post-transplant hospital admissions were performed. A total of 17% of patients reported medication trade-offs; the most common trade-offs were inability to afford a prescription in the past 12 months and making choices between prescriptions and food. In multivariable analysis, insurance type (RR: 2.97, 95% CI: 1.19-7.40), limited health literacy (RR: 2.64, 95% CI: 1.23-5.64), and ≥3 comorbid conditions (RR: 2.48, 95% CI: 1.09-5.62; all P < 0.05) were associated with trade-offs. Patients with trade-offs were more likely to report nonadherence to medications (mean adherence: 77 ± 23% with trade-offs vs. 89 ± 19% without trade-offs, P < 0.01). The presence of medication trade-offs was associated with post-transplant hospital admissions (RR 1.64, 95% CI 1.14-2.35, P < 0.01). Assessments of financial barriers are warranted in clinical practice to identify nonadherence and improve post-transplant outcomes.
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Affiliation(s)
- Marina Serper
- Division of Gastroenterology, Department of Medicine, School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Peter P Reese
- Department of Medicine, Renal Electrolyte and Hypertension Division, University of Pennsylvania, Philadelphia, Pennsylvania, USA.,Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Rachel R Patzer
- Division of Transplantation, Department of Surgery, Emory University School of Medicine, Atlanta, GA, USA.,Department of Epidemiology, Rollins School of Public Health, Emory University School of Medicine, Atlanta, GA, USA
| | - Josh Levitsky
- Comprehensive Transplant Center (CTC), Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Michael S Wolf
- Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA.,Health Literacy and Learning Program, Division of General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
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30
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Whitsett M, Levitsky J. Medication nonadherence in liver transplantation. Clin Liver Dis (Hoboken) 2017; 10:157-160. [PMID: 30992778 PMCID: PMC6467125 DOI: 10.1002/cld.680] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/13/2017] [Revised: 10/17/2017] [Accepted: 11/05/2017] [Indexed: 02/04/2023] Open
Affiliation(s)
| | - Josh Levitsky
- Division of Gastroenterology & HepatologyMcGaw Medical Center of Northwestern UniversityChicagoIL
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31
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Thrall SA, Fominaya CE, Chiasson JM, Castle S, Taber DJ. Improvement in immunosuppression therapy monitoring in organ transplant recipients. Am J Health Syst Pharm 2017; 74:S67-S74. [PMID: 28842520 DOI: 10.2146/ajhp160872] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
PURPOSE The results of a study to determine whether a technology-enabled pharmacist intervention improved immunosuppression monitoring in organ transplant recipients are presented. METHODS This was a retrospective, longitudinal cohort study. Eligible patients included veteran solid organ transplant recipients receiving immunosuppression therapy from a Veterans Affairs Medical Center (VAMC) between July 1, 2013, and July 1, 2015. A clinical pharmacist used an electronic surveillance system to determine need for laboratory monitoring and engaged the recipients to obtain regular laboratory monitoring at the VAMC or an outside facility. The primary aim was to determine whether the intervention improved immunosuppression monitoring using an interrupted time series inquiry with segmented regression analysis. The secondary aim was to assess care coordination using descriptive statistics. RESULTS A total of 110 veteran transplant recipients were included; 96% were male, 50% received kidney transplants, 36% received liver transplants, and 14% received thoracic transplants. During the 6-month initial intervention period, the rate of patients meeting minimum immunosuppression monitoring criteria increased by 4.7% per month (p < 0.001). The monthly rate of patients meeting immunosuppressant monitoring for tacrolimus, cyclosporine, and antimetabolites increased by 4.1% (p = 0.0013), 9.5% (p = 0.0442), and 1.5% (p = 0.0077), respectively. The clinical pharmacist performed 126 medication reconciliations, documented 259 outside laboratory values, and referred 9 patients to other providers. CONCLUSION Clinical pharmacist intervention resulted in an increased number of patients with solid organ transplant meeting minimum immunosuppressant monitoring recommendations.
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Affiliation(s)
- Stephanie A Thrall
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC, and College of Pharmacy, Medical University of South Carolina, Charleston, SC.
| | - Cory E Fominaya
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC
| | - Jordan M Chiasson
- College of Pharmacy, Medical University of South Carolina, Charleston, SC
| | - Sharon Castle
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC
| | - David J Taber
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC, and Division of Transplant Surgery and College of Medicine, Medical University of South Carolina, Charleston, SC
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Nevins TE, Nickerson PW, Dew MA. Understanding Medication Nonadherence after Kidney Transplant. J Am Soc Nephrol 2017; 28:2290-2301. [PMID: 28630231 PMCID: PMC5533244 DOI: 10.1681/asn.2017020216] [Citation(s) in RCA: 100] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023] Open
Abstract
Alloimmunity remains a barrier to long-term graft survival that necessitates lifelong immunosuppressive therapy after renal transplant. Medication nonadherence has been increasingly recognized as a major impediment to achieving effective immunosuppression. Electronic medication monitoring further reveals that nonadherence manifests early after transplant, although the effect is delayed. The etiology of nonadherence is multifactorial, with the strongest risk factors including past nonadherence and being an adolescent or young adult. Other risk factors with smaller but consistently important effects include minority race/ethnicity, poor social supports, and poor perceived health. In children, risk factors related to parental and child psychologic and behavioral functioning and parental distress and burden are also important. Qualitative systematic reviews highlight the need to tailor interventions to each transplant recipient's unique needs, motivations, and barriers rather than offer a one size fits all approach. To date, relatively few interventions have been studied, and most studies conducted were underpowered to allow definitive conclusions. If the kidney transplant community's goal of "one transplant for life" is to become a reality, then solutions for medication nonadherence must be found and implemented.
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Affiliation(s)
- Thomas E. Nevins
- Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota
| | - Peter W. Nickerson
- Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; and
| | - Mary Amanda Dew
- Department of Psychiatry, University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania
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Dew MA, DeVito Dabbs AJ, DiMartini AF. Gaining ground in efforts to promote medication adherence after organ transplantation. J Heart Lung Transplant 2017; 36:488-490. [PMID: 28318746 DOI: 10.1016/j.healun.2017.02.019] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2017] [Accepted: 02/19/2017] [Indexed: 10/20/2022] Open
Affiliation(s)
- Mary Amanda Dew
- Department of Psychiatry, University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania, USA; Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA; Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA; Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA; Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
| | - Annette J DeVito Dabbs
- Department of Acute and Tertiary Care, University of Pittsburgh School of Nursing, Pittsburgh, Pennyslvania, USA
| | - Andrea F DiMartini
- Department of Psychiatry, University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania, USA; Department of Surgery, University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania, USA
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Zanetti-Yabur A, Rizzo A, Hayde N, Watkins AC, Rocca JP, Graham JA. Exploring the usage of a mobile phone application in transplanted patients to encourage medication compliance and education. Am J Surg 2017; 214:743-747. [PMID: 28256241 DOI: 10.1016/j.amjsurg.2017.01.026] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2016] [Revised: 01/11/2017] [Accepted: 01/19/2017] [Indexed: 10/20/2022]
Abstract
BACKGROUND Medication non-adherence in transplant patients is a grave problem that results in increased rejection episodes, graft loss and significant morbidity. METHODS The efficacy of users and non-users of a mobile phone application (mobile app) in promoting medication adherence was investigated. The Beliefs about Medicine Questionnaire (BMQ) and Morisky Medication Adherence Scale (MMAS-8) were used in these cohorts to assess the predilection for poor adherence. Serum tacrolimus, creatinine levels, and rejection episodes were also recorded. Lastly, the patients were tested on their recall of their immunosuppression. RESULTS Overall, patients had extremely negative beliefs about medication reflected in their tendency toward higher predicted rates of non-adherence. Interestingly, though not significant, app users had higher rates of medication recollection. CONCLUSIONS The high-risk nature of this population demands efforts to abrogate non-adherence. Caregivers are charged with the responsibility to offer patients a feasible option to safeguard treatment compliance. Mobile apps are a potentially powerful tool, which can be used to decrease non-adherence.
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Affiliation(s)
- Alana Zanetti-Yabur
- Montefiore - Einstein Center for Transplantation, Montefiore Medical Center, Bronx, NY, USA.
| | - Amanda Rizzo
- Albert Einstein College of Medicine, Bronx, NY, USA
| | - Nicole Hayde
- Division of Pediatric Nephrology, Montefiore Medical Center, Bronx, NY, USA
| | - Anthony C Watkins
- New York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA
| | - Juan P Rocca
- Montefiore - Einstein Center for Transplantation, Montefiore Medical Center, Bronx, NY, USA
| | - Jay A Graham
- Montefiore - Einstein Center for Transplantation, Montefiore Medical Center, Bronx, NY, USA
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Dobbels F, De Bleser L, Berben L, Kristanto P, Dupont L, Nevens F, Vanhaecke J, Verleden G, De Geest S. Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. J Heart Lung Transplant 2017; 36:499-508. [PMID: 28162931 DOI: 10.1016/j.healun.2017.01.007] [Citation(s) in RCA: 83] [Impact Index Per Article: 10.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2016] [Revised: 12/22/2016] [Accepted: 01/04/2017] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND Well-designed randomized controlled trials (RCTs) testing efficacy of post-transplant medication adherence enhancing interventions and clinical outcomes are scarce. METHODS This randomized controlled trial enrolled adult heart, liver, and lung transplant recipients who were >1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3-month run-in period, patients were randomly assigned 1:1 to intervention group (IG) or control group (CG) (visit 2), followed by a 6-month intervention (visits 2-4) and a 6-month adherence follow-up period (visit 5). All patients used electronic monitoring for 15 months for adherence measurement, generating a daily binary adherence score per patient. Post-intervention 5-year clinical event-free survival (mortality or retransplantation) was evaluated. The IG received staged multicomponent tailored behavioral interventions (visits 2-4) building on social cognitive theory and trans-theoretical model (e.g., electronic monitoring feedback, motivational interviewing). The CG received usual care and attended visits 1-5 only. Intention-to-treat analysis used generalized estimating equation modeling and Kaplan-Meier survival analysis. RESULTS Of 247 patients, 205 were randomly assigned (103 IG, 102 CG). At baseline, average daily proportions of patients with correct dosing (82.6% IG, 78.4% CG) and timing adherence (75.8% IG, 72.2% CG) were comparable. The IG had a 16% higher dosing adherence post-intervention (95.1% IG, 79.1% CG; p < 0.001), resulting in odds of adherence being 5 times higher in the IG than in the CG (odds ratio 5.17, 95% confidence interval 2.86-9.38). This effect was sustained at end of follow-up (similar results for timing adherence). In the IG, 5-year clinical event-free survival was 82.5% vs 72.5% in the CG (p = 0.18). CONCLUSION Our intervention was efficacious in improving adherence and sustainable. Further research should investigate clinical impact, cost-effectiveness, and scalability.
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Affiliation(s)
- Fabienne Dobbels
- Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland.
| | - Leentje De Bleser
- Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium
| | - Lut Berben
- Institute of Nursing Science, University of Basel, Basel, Switzerland
| | | | - Lieven Dupont
- Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Frederik Nevens
- Liver Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Johan Vanhaecke
- Heart Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Geert Verleden
- Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Sabina De Geest
- Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland
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Russell CL, Moore S, Hathaway D, Cheng AL, Chen G, Goggin K. MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients. BMC Nephrol 2016; 17:84. [PMID: 27421884 PMCID: PMC4947243 DOI: 10.1186/s12882-016-0285-8] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2016] [Accepted: 06/24/2016] [Indexed: 11/20/2022] Open
Abstract
BACKGROUND Among adult kidney transplant recipients, non-adherence to immunosuppressive medications is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of kidney transplant patients experience medication non-adherence even though the problem is preventable. Existing adherence interventions have proven marginally effective for those with acute and chronic illnesses and ineffective for adult kidney transplant recipients. Our purpose is to describe the design and methods of the MAGIC (Medication Adherence Given Individual SystemCHANGE™) trial METHODS/DESIGN We report the design of a randomized controlled trial with an attention-control group to test an innovative 6-month SystemCHANGE™ intervention designed to enhance immunosuppressive medication adherence in adult non-adherent kidney transplant recipients from two transplant centers. Grounded in the Socio-Ecological Model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-led experiments to change and maintain behavior. After a 3-month screening phase of 190 eligible adult kidney transplant recipients, those who are <85 % adherent as measured by electronic monitoring, will be randomized into a 6-month SystemCHANGE™ intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention. Differences in adherence between the two groups will be assessed at baseline, 6 months (intervention phase) and 12 months (maintenance phase). Adherence mediators (social support, systems-thinking) and moderators (ethnicity, perceived health) are examined. Patient outcomes (creatinine/blood urea nitrogen, infection, acute/chronic rejection, graft loss, death) and cost effectiveness are to be examined. DISCUSSION Based on the large effect size of 1.4 found in our pilot study, intervention shows great promise for increasing adherence. Grounded in the socio-ecological model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. Medication adherence will be measured by electronic monitoring. Medication adherence persistence will be examined by evaluating differences between the two groups at the end of the 6-and 12- month phases. Mediators and moderators of medication adherence will be examined. Patient outcomes will be compared and a cost-effectiveness analysis will be conducted. TRIAL REGISTRATION ClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.
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Affiliation(s)
- Cynthia L. Russell
- />School of Nursing and Health Studies, University of Missouri-Kansas City, Health Sciences Building 2407, Kansas City, MO 64108 USA
| | - Shirley Moore
- />Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH 44106 USA
| | - Donna Hathaway
- />Department of Advanced Practice and Doctoral Studies, 920 Madison, #924, Memphis, TN 38163 USA
| | - An-Lin Cheng
- />School of Nursing and Health Studies, University of Missouri-Kansas City, Health Sciences Building 2407, Kansas City, MO 64108 USA
| | - Guoqing Chen
- />Department of Internal Medicine, University of Kansas Medical Center, 4043 Wescoe, MS 1037 3901 Rainbow Blvd, Kansas City, KS 66160 USA
| | - Kathy Goggin
- />Health Services and Outcomes Research, Children’s Mercy Hospitals and Clinics, University of Missouri - Kansas City Schools of Medicine and Pharmacy, 2401 Gillham Road, Kansas City, MO 64108 USA
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Corrêa PM, Zuckermann J, Fischer GB, Castro MS. Immunosuppressive serum levels in allogeneic hematopoietic stem cell transplantation: pharmaceutical care contribution. Pharm Pract (Granada) 2016; 14:683. [PMID: 27382420 PMCID: PMC4930854 DOI: 10.18549/pharmpract.2016.02.683] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2015] [Accepted: 06/04/2016] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND Cyclosporine and tacrolimus are limited by a narrow therapeutic window. Maintaining immunosuppressive drugs at desired levels may be difficult. Pharmaceutical care emerges as a philosophy of practice that enhances medication use and leads to a better control of serum concentration. OBJECTIVE This study aims to evaluate the impact of pharmaceutical care in the maintaining of proper serum levels of immunosuppressive medications in patients who have undergone allo-HSCT. METHODS The study had a quasi-experimental design that included a comparison group. The service model used was pharmacotherapy follow-up, according to an adaptation of the Dader method. The pharmacist consultation was carried out at a day-hospital or at the outpatient hematology clinic as needed. The intervention group consisted of 22 patients seen by a clinical pharmacist. The control group consisted of 44 patients that received standard care. This study aims to evaluate the impact of pharmaceutical care on keeping patient serum levels of cyclosporine and tacrolimus within the desired range. RESULTS Control group displayed 65% of the proper serum levels of immunosuppressive agents. While In intervention group, the figure was 82% (p = 0.004). CONCLUSION The role of the pharmacist in the multidisciplinary team may contribute to a greater success in attaining the patients' therapeutic targets with regard to the use of immunosuppressant.
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Affiliation(s)
- Paulo M Corrêa
- Professor of Pharmaceutical Sciences at Universidade Federal do Amazonas . Itacoatiara ( Brazil ).
| | | | - Gustavo B Fischer
- Physician at Hospital de Clínicas de Porto Alegre. Porto Alegre ( Brazil ).
| | - Mauro S Castro
- Professor at School of Pharmacy at Universidade Federal do Rio Grande do Sul Brazil . Porto Alegre ( Brazil ).
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38
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Value of solid organ transplant-trained pharmacists in transplant infectious diseases. Curr Infect Dis Rep 2015; 17:475. [PMID: 25870143 DOI: 10.1007/s11908-015-0475-8] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
Advances in organ transplantation have led to improved graft and patient survival. Transplant pharmacist's education and training uniquely position them to contribute knowledge and skills to the management of these highly complex patients. In 2004, the United Network for Organ Sharing bylaws added requirements that all transplant programs identify one or more pharmacists with experience in transplant pharmacotherapy to be responsible for providing pharmaceutical care to solid organ transplant recipients. These bylaws also delineated the transplant pharmacist's roles and responsibilities. To further support these efforts, in 2007 the Centers for Medicare and Medicaid Services accreditation standards for transplant centers also mandated that a center have a designated, qualified expert in transplant pharmacology as a multidisciplinary team member. The transplant pharmacist is a consistent member of the transplant team that can add value to the multidisciplinary approach of prevention and treatment of transplant infectious diseases through all phases of transplant care.
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Serper M, Patzer RE, Reese PP, Przytula K, Koval R, Ladner DP, Levitsky J, Abecassis MM, Wolf MS. Medication misuse, nonadherence, and clinical outcomes among liver transplant recipients. Liver Transpl 2015; 21:22-8. [PMID: 25312406 PMCID: PMC5831120 DOI: 10.1002/lt.24023] [Citation(s) in RCA: 73] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2014] [Revised: 09/05/2014] [Accepted: 09/11/2014] [Indexed: 12/31/2022]
Abstract
Medication nonadherence after liver transplantation (LT) is associated with adverse clinical outcomes such as graft rejection and graft loss. Few studies have examined nonadherence and its impact on clinical outcomes in LT. The study objectives were (1) to evaluate medication understanding (with treatment knowledge and demonstrated regimen use scores) and medication adherence or nonadherence to entire regimens among LT recipients and (2) to examine associations of these exposures with clinical outcomes. We conducted a 2-site study of 105 recipients between 2011 and 2012 at 2 transplant centers in Chicago, IL and Atlanta, GA. Data were collected via detailed, in-person interviews and medical record reviews. Study participants were middle-aged and predominantly male; 15% of the sample had limited literacy. On average, patients were taking 11 medications [standard deviation (SD) = 4], and 39% had undergone a medication change within the last month. The average scores for the entire medication regimen were 86% (SD = 22%) for treatment knowledge and 78% (SD = 22%) for demonstrated regimen use. The mean score for self-reported nonadherence to the entire regimen was 14% (SD = 20%), whereas 32% of the patients were nonadherent according to tacrolimus levels. In multivariate analyses, lower income, less time since transplantation, a higher number of medications, and limited literacy were inversely associated with treatment knowledge scores (all P < 0.05), whereas limited literacy was associated with nonadherence according to tacrolimus levels (P < 0.05). In multivariate models, higher scores for treatment knowledge [incidence rate ratio (IRR) = 0.85, 95% confidence interval (CI) = 0.74-0.97] and demonstrated regimen use (IRR = 0.87, 95% confidence interval = 0.77-0.98) were independently associated with 15% and 13% reductions in the number of posttransplant rehospitalizations, respectively. Inadequate treatment knowledge and improper regimen use may be significant determinants of unintentional nonadherence among LT recipients and are associated with adverse clinical outcomes.
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Affiliation(s)
- Marina Serper
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
| | - Rachel E. Patzer
- Division of Transplantation, Department of Surgery, Emory University School of Medicine, Atlanta, GA,Department of Epidemiology, Rollins School of Public Health, Atlanta, GA
| | - Peter P. Reese
- Renal-Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
| | - Kamila Przytula
- Health Literacy and Learning Program, Division of General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL
| | - Rachel Koval
- Division of Transplantation, Department of Surgery, Emory University School of Medicine, Atlanta, GA
| | - Daniela P. Ladner
- Northwestern University Transplant Outcomes Research Collaborative, Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
| | - Josh Levitsky
- Northwestern University Transplant Outcomes Research Collaborative, Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
| | - Michael M. Abecassis
- Northwestern University Transplant Outcomes Research Collaborative, Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
| | - Michael S. Wolf
- Health Literacy and Learning Program, Division of General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL,Northwestern University Transplant Outcomes Research Collaborative, Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL,Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL
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Abstract
Poor adherence to immunosuppressive medications may be the most important barrier to long term graft survival. An understanding of medication adherence and its determinants is critical to addressing this important problem. In this paper, we will review the different ways in which adherence may be compromised, summarize the evidence that young people constitute a particularly high risk group, and consider the consequences and impact of poor adherence. We will also review the determinants of adherence, including characteristics of the patient and family, the treatment regimen, the healthcare team and its organization, and the healthcare system. We will highlight the most common barriers to adherence identified by young people, and consider different methods of measuring adherence, along with the advantages and limitations of each. Finally, we will consider possible intervention strategies to improve adherence in young people.
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Tichy EM, Pilch NA, Smith LD, Maldonado AQ, Taber DJ. Building a business plan to support a transplantation pharmacy practice model. Am J Health Syst Pharm 2014; 71:751-7. [PMID: 24733139 DOI: 10.2146/ajhp130555] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Affiliation(s)
- Eric M Tichy
- Eric M. Tichy, Pharm.D., BCPS, is Senior Clinical Pharmacy Specialist, Solid Organ Transplant, and Director, Postgraduate Year 2 Pharmacy Residency-Transplant, Department of Pharmacy, Yale-New Haven Hospital, New Haven, CT. Nicole A. Pilch, Pharm.D., M.S.C.R., BCPS, is Clinical Specialist, Solid Organ Transplantation, and Clinical Assistant Professor, Department of Pharmacy and Clinical Sciences, South Carolina College of Pharmacy, Medical University of South Carolina, Charleston. Lonnie D. Smith, Pharm.D., is Manager, Department of Solid Organ Transplant, and Director, Postgraduate Year 2 Pharmacy Residency-Transplant, University of Utah Hospitals and Clinics, Salt Lake City. Angela Q. Maldonado, Pharm.D., BCPS, is Clinical Pharmacy Specialist-Transplant Services, Vidant Medical Center, Greenville, NC. David J. Taber, Pharm.D., BCPS, is Director, Clinical Research, and Assistant Professor of Surgery, Medical University of South Carolina
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Kuntz JL, Safford MM, Singh JA, Phansalkar S, Slight SP, Her QL, Lapointe NA, Mathews R, O'Brien E, Brinkman WB, Hommel K, Farmer KC, Klinger E, Maniam N, Sobko HJ, Bailey SC, Cho I, Rumptz MH, Vandermeer ML, Hornbrook MC. Patient-centered interventions to improve medication management and adherence: a qualitative review of research findings. PATIENT EDUCATION AND COUNSELING 2014; 97:310-26. [PMID: 25264309 PMCID: PMC5830099 DOI: 10.1016/j.pec.2014.08.021] [Citation(s) in RCA: 81] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/21/2014] [Revised: 08/26/2014] [Accepted: 08/30/2014] [Indexed: 05/23/2023]
Abstract
OBJECTIVE Patient-centered approaches to improving medication adherence hold promise, but evidence of their effectiveness is unclear. This review reports the current state of scientific research around interventions to improve medication management through four patient-centered domains: shared decision-making, methods to enhance effective prescribing, systems for eliciting and acting on patient feedback about medication use and treatment goals, and medication-taking behavior. METHODS We reviewed literature on interventions that fell into these domains and were published between January 2007 and May 2013. Two reviewers abstracted information and categorized studies by intervention type. RESULTS We identified 60 studies, of which 40% focused on patient education. Other intervention types included augmented pharmacy services, decision aids, shared decision-making, and clinical review of patient adherence. Medication adherence was an outcome in most (70%) of the studies, although 50% also examined patient-centered outcomes. CONCLUSIONS We identified a large number of medication management interventions that incorporated patient-centered care and improved patient outcomes. We were unable to determine whether these interventions are more effective than traditional medication adherence interventions. PRACTICE IMPLICATIONS Additional research is needed to identify effective and feasible approaches to incorporate patient-centeredness into the medication management processes of the current health care system, if appropriate.
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Affiliation(s)
- Jennifer L Kuntz
- Center for Health Research, Kaiser Permanente Northwest, Portland, USA.
| | - Monika M Safford
- Division Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, USA
| | - Jasvinder A Singh
- Division Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, USA
| | - Shobha Phansalkar
- Partners Healthcare Systems, Inc., Wellesley, USA; Brigham and Women's Hospital and Harvard Medical School, Boston, USA
| | - Sarah P Slight
- Partners Healthcare Systems, Inc., Wellesley, USA; Brigham and Women's Hospital and Harvard Medical School, Boston, USA
| | | | | | | | | | | | - Kevin Hommel
- Cincinnati Children's Hospital and Medical Center, Cincinnati, USA
| | - Kevin C Farmer
- The University of Oklahoma College of Pharmacy, Oklahoma City, USA
| | - Elissa Klinger
- Brigham and Women's Hospital and Harvard Medical School, Boston, USA
| | | | - Heather J Sobko
- Division Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, USA
| | - Stacy C Bailey
- University of North Carolina, Eshelman School of Pharmacy, Chapel Hill, USA
| | - Insook Cho
- Brigham and Women's Hospital and Harvard Medical School, Boston, USA
| | - Maureen H Rumptz
- Center for Health Research, Kaiser Permanente Northwest, Portland, USA
| | | | - Mark C Hornbrook
- Center for Health Research, Kaiser Permanente Northwest, Portland, USA
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Gutermann L, Decottignies A, Sharif K, Sinclair A, Rieutord A, Terry D. Parents and carers of patients who had liver transplants: opinions and experiences of medication issues. Eur J Hosp Pharm 2014. [DOI: 10.1136/ejhpharm-2013-000439] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/03/2022] Open
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Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014; 2014:CD000011. [PMID: 25412402 PMCID: PMC7263418 DOI: 10.1002/14651858.cd000011.pub4] [Citation(s) in RCA: 710] [Impact Index Per Article: 64.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND People who are prescribed self administered medications typically take only about half their prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits of prescribed medications. OBJECTIVES The primary objective of this review is to assess the effects of interventions intended to enhance patient adherence to prescribed medications for medical conditions, on both medication adherence and clinical outcomes. SEARCH METHODS We updated searches of The Cochrane Library, including CENTRAL (via http://onlinelibrary.wiley.com/cochranelibrary/search/), MEDLINE, EMBASE, PsycINFO (all via Ovid), CINAHL (via EBSCO), and Sociological Abstracts (via ProQuest) on 11 January 2013 with no language restriction. We also reviewed bibliographies in articles on patient adherence, and contacted authors of relevant original and review articles. SELECTION CRITERIA We included unconfounded RCTs of interventions to improve adherence with prescribed medications, measuring both medication adherence and clinical outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive findings at earlier time points. DATA COLLECTION AND ANALYSIS Two review authors independently extracted all data and a third author resolved disagreements. The studies differed widely according to medical condition, patient population, intervention, measures of adherence, and clinical outcomes. Pooling results according to one of these characteristics still leaves highly heterogeneous groups, and we could not justify meta-analysis. Instead, we conducted a qualitative analysis with a focus on the RCTs with the lowest risk of bias for study design and the primary clinical outcome. MAIN RESULTS The present update included 109 new RCTs published since the previous update in January 2007, bringing the total number of RCTs to 182; we found five RCTs from the previous update to be ineligible and excluded them. Studies were heterogeneous for patients, medical problems, treatment regimens, adherence interventions, and adherence and clinical outcome measurements, and most had high risk of bias. The main changes in comparison with the previous update include that we now: 1) report a lack of convincing evidence also specifically among the studies with the lowest risk of bias; 2) do not try to classify studies according to intervention type any more, due to the large heterogeneity; 3) make our database available for collaboration on sub-analyses, in acknowledgement of the need to make collective advancement in this difficult field of research. Of all 182 RCTs, 17 had the lowest risk of bias for study design features and their primary clinical outcome, 11 from the present update and six from the previous update. The RCTs at lowest risk of bias generally involved complex interventions with multiple components, trying to overcome barriers to adherence by means of tailored ongoing support from allied health professionals such as pharmacists, who often delivered intense education, counseling (including motivational interviewing or cognitive behavioral therapy by professionals) or daily treatment support (or both), and sometimes additional support from family or peers. Only five of these RCTs reported improvements in both adherence and clinical outcomes, and no common intervention characteristics were apparent. Even the most effective interventions did not lead to large improvements in adherence or clinical outcomes. AUTHORS' CONCLUSIONS Across the body of evidence, effects were inconsistent from study to study, and only a minority of lowest risk of bias RCTs improved both adherence and clinical outcomes. Current methods of improving medication adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. The research in this field needs advances, including improved design of feasible long-term interventions, objective adherence measures, and sufficient study power to detect improvements in patient-important clinical outcomes. By making our comprehensive database available for sharing we hope to contribute to achieving these advances.
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Affiliation(s)
- Robby Nieuwlaat
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Nancy Wilczynski
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Tamara Navarro
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Nicholas Hobson
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Rebecca Jeffery
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Arun Keepanasseril
- McMaster UniversityDepartments of Clinical Epidemiology & Biostatistics, and Medicine, Faculty of Health Sciences1280 Main Street WestHamiltonONCanadaL8S 4L8
| | - Thomas Agoritsas
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Niraj Mistry
- St. Michael's HospitalDepartment of Pediatrics30 Bond StreetTorontoONCanadaM5B 1W8
| | - Alfonso Iorio
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Susan Jack
- McMaster UniversitySchool of Nursing, Faculty of Health SciencesHealth Sciences CentreRoom 2J32, 1280 Main Street WestHamiltonONCanadaL8S 4K1
| | | | - Emma Iserman
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Reem A Mustafa
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Dawn Jedraszewski
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - Chris Cotoi
- McMaster UniversityDepartment of Clinical Epidemiology and BiostatisticsHamilton General Hospital campus, Room C3‐107237 Barton Street EastHamiltonONCanadaL8L 2X2
| | - R. Brian Haynes
- McMaster UniversityDepartments of Clinical Epidemiology & Biostatistics, and Medicine, Faculty of Health Sciences1280 Main Street WestHamiltonONCanadaL8S 4L8
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Influence of intention to adhere, beliefs and satisfaction about medicines on adherence in solid organ transplant recipients. Transplantation 2014; 98:222-8. [PMID: 24926826 DOI: 10.1097/tp.0000000000000221] [Citation(s) in RCA: 45] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/22/2023]
Abstract
INTRODUCTION Nonadherence to immunosuppressive (IS) therapy is associated with poor outcomes. Identifying factors predicting poor adherence is therefore essential. The primary objective of this study was to test whether parameters of a model adapted from the theory of planned behavior, and more specifically attitudes that are influenced by beliefs and satisfaction with medication, could predict adherence in solid organ transplant patients. METHODS Adherence was assessed with a self-reported medication adherence scale and IS blood trough concentrations over 6 months, in four transplant units. Satisfaction and beliefs were assessed using the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) and Beliefs about Medicines Questionnaire (BMQ), respectively. Theory of planned behavior was assessed with a specific questionnaire exploring intentions, subjective norms, attitudes and perceived behavioral control. Treatment characteristics and socioeconomic data were also collected. RESULTS One hundred and fifty-three solid organ transplant patients were enrolled, including lung (n=33), heart (n=43), liver (n=42), and kidney (n=44) patients. Satisfaction and positive beliefs about medication were higher in adherent than those in nonadherent patients. Factors independently associated with an increased risk of nonadherence were negative general beliefs about medications (odds ratio [OR]=0.89 [0.83-0.97]), living alone (OR=2.78 [1.09-7.09]), heart transplantation (OR=3.49 [1.34-9.09]), and being on everolimus (OR=5.02 [1.21-20.8]). CONCLUSION Negative beliefs toward medications were shown to be an independent risk factor of poor adherence. Therefore, the BMQ could be an effective, easy to implement tool, for use in everyday practice, to identify patients needing interventions to improve adherence to IS.
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Bardet JD, Charpiat B, Bedouch P, Rebillon M, Ducerf C, Gauchet A, Tourette-Turgis C, Allenet B. Illness representation and treatment beliefs in liver transplantation: An exploratory qualitative study. ANNALES PHARMACEUTIQUES FRANÇAISES 2014; 72:375-87. [DOI: 10.1016/j.pharma.2014.05.005] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2014] [Revised: 05/26/2014] [Accepted: 05/27/2014] [Indexed: 01/23/2023]
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Foster BJ, Pai A, Zhao H, Furth S. The TAKE-IT study: aims, design, and methods. BMC Nephrol 2014; 15:139. [PMID: 25176317 PMCID: PMC4236658 DOI: 10.1186/1471-2369-15-139] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2014] [Accepted: 08/21/2014] [Indexed: 12/03/2022] Open
Abstract
Background Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed. This paper describes the aims, design, and methods of the Teen Adherence in Kidney transplant, Effectiveness of Intervention Trial (TAKE-IT) study. Design and methods TAKE-IT is a multicentre, prospective, open-label, parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention, including educational, organizational, and behavioural components, in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients. Individuals between 11 and 24 years of age who are at least 3 months post-transplant and followed in one of the eight participating pediatric kidney transplant programs, or their affiliated adult transplant programs are eligible to participate. All participating centers are tertiary care pediatric hospitals in Canada or the United States. Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period, followed by a 12-month intervention interval. The primary outcome is ‘taking adherence’, defined as the proportion of prescribed doses of immunosuppressive medications that were taken, as measured using electronic monitoring. All participants meet with the study ‘Coach’ at 3 month intervals. The intervention, administered by trained lay personnel, targets common adherence barriers. In addition to forming an Adherence Support Team, intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them, have their electronic adherence data fed back to them, and have the option to receive email, text message, or visual cue dose reminders. Participants in the control group meet with the coach but do not receive the other components of the intervention. The study aims to have 75 participants in each group complete the study. Discussion Since recruitment began in Feb. 2012, 198 adolescents have been approached to participate, of whom 130 have completed a baseline visit. As of March 31, 2014, 125 had been randomized, and 86, 68, 61, and 50 participants had completed 6-month, 9-month, 12-month, and 15-month visits respectively. Trial registration Clinicaltrials.gov registration
NCT01356277 (May 17, 2011).
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Affiliation(s)
- Bethany J Foster
- Montreal Children's Hospital, 2300 Tupper St, E-222, Montreal, Quebec H3H 1P3, Canada.
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Joost R, Dörje F, Schwitulla J, Eckardt KU, Hugo C. Intensified pharmaceutical care is improving immunosuppressive medication adherence in kidney transplant recipients during the first post-transplant year: a quasi-experimental study. Nephrol Dial Transplant 2014; 29:1597-607. [PMID: 24914089 DOI: 10.1093/ndt/gfu207] [Citation(s) in RCA: 54] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND Medication adherence is critical for transplant patients because the consequences of non-adherence can result in allograft loss and may be life threatening. METHODS A prospective study with 74 renal transplant recipients using a sequential control group design was performed to investigate the impact of a pharmaceutical intensified care programme led by a clinical pharmacist on daily drug adherence during the first year after renal transplantation. Thirty-nine patients of the control group received the already established standardized drug and transplant training, while 35 patients of the intensified care group (ICG) received additional inpatient and outpatient pharmaceutical care and counselling by a dedicated clinical pharmacist. Applied interventions were clustered and classified using the behaviour change technique taxonomy according to Michie. Adherence to immunosuppressive drug therapy was monitored up to 1 year using a medication event monitoring system, pill count (PC), drug holiday (DH) occurrence, Morisky questionnaire and self-report. RESULTS Sixty-seven patients (35 of the standard care and 32 of the ICG) were analysed. Implementation of DA was significantly (P = 0.014) improved in patients of the ICG (91%) compared with SCG (75%) during the first year after transplantion. Daily adherence measures were already improved within 30-40 days after start of intensified patient care and continued throughout the study period. Intensified care patients also showed significantly better results for taking adherence (P = 0.006), PC (P = 0.008) and DHs (P = 0.001). CONCLUSIONS The additional, intensified pharmaceutical care improved patients' medication adherence remarkably, suggesting that the applied additional care programme has the potential to improve outcomes after organ transplantation.
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Affiliation(s)
- Robert Joost
- Pharmacy Department, Erlangen University Hospital, Erlangen, Germany
| | - Frank Dörje
- Pharmacy Department, Erlangen University Hospital, Erlangen, Germany
| | - Judith Schwitulla
- Department of Medical Informatics, Biometry and Epidemiology, Friedrich Alexander University of Erlangen-Nürnberg (FAU), Erlangen, Germany
| | - Kai-Uwe Eckardt
- Department of Nephrology and Hypertension, University of Erlangen-Nürnberg (FAU), Erlangen, Germany
| | - Christian Hugo
- Medizinische Klinik III, Bereich Nephrologie, Universitätsklinikum Carl Gustav Carus, Dresden, Germany
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Identification and assessment of adherence-enhancing interventions in studies assessing medication adherence through electronically compiled drug dosing histories: a systematic literature review and meta-analysis. Drugs 2014; 73:545-62. [PMID: 23588595 PMCID: PMC3647098 DOI: 10.1007/s40265-013-0041-3] [Citation(s) in RCA: 227] [Impact Index Per Article: 20.6] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
Background Non-adherence to medications is prevalent across all medical conditions that include ambulatory pharmacotherapy and is thus a major barrier to achieving the benefits of otherwise effective medicines. Objective The objective of this systematic review was to identify and to compare the efficacy of strategies and components thereof that improve implementation of the prescribed drug dosing regimen and maintain long-term persistence, based on quantitative evaluation of effect sizes across the aggregated trials. Data sources MEDLINE, EMBASE, CINAHL, the Cochrane Library, and PsycINFO were systematically searched for randomized controlled trials that tested the efficacy of adherence-enhancing strategies with self-administered medications. The searches were limited to papers in the English language and were included from database inception to 31 December 2011. Study selection Our review included randomized controlled trials in which adherence was assessed by electronically compiled drug dosing histories. Five thousand four hundred studies were screened. Eligibility assessment was performed independently by two reviewers. A structured data collection sheet was developed to extract data from each study. Study appraisal and synthesis methods The adherence-enhancing components were classified in eight categories. Quality of the papers was assessed using the criteria of the Cochrane Handbook for Systematic Reviews of Interventions guidelines to assess potential bias. A combined adherence outcome was derived from the different adherence variables available in the studies by extracting from each paper the available adherence summary variables in a pre-defined order (correct dosing, taking adherence, timing adherence, percentage of adherent patients). To study the association between the adherence-enhancing components and their effect on adherence, a linear meta-regression model, based on mean adherence point estimates, and a meta-analysis were conducted. Results Seventy-nine clinical trials published between 1995 and December 2011 were included in the review. Patients randomized to an intervention group had an average combined adherence outcome of 74.3 %, which was 14.1 % higher than in patients randomized to the control group (60.2 %). The linear meta-regression analysis with stepwise variable selection estimated an 8.8 % increase in adherence when the intervention included feedback to the patients of their recent dosing history (EM-feedback) (p < 0.01) and a 5.0 % increase in adherence when the intervention included a cognitive-educational component (p = 0.02). In addition, the effect of interventions on adherence decreased by 1.1 % each month. Sensitivity analysis by selecting only high-quality papers confirmed the robustness of the model. The random effects model in the meta-analysis, conducted on 48 studies, confirmed the above findings and showed that the improvement in adherence was 19.8 % (95 % CI 10.7–28.9 %) among patients receiving EM-feedback, almost double the improvement in adherence for studies that did not include this type of feedback [10.3 % (95 % CI 7.5–13.1 %)] (p < 0.01). The improvement in adherence was 16.1 % (95 % CI 10.7–21.6 %) in studies that tested cognitive-educational components versus 10.1 % (95 % CI 6.6–13.6 %) in studies that did not include this type of intervention (p = 0.04). Among 57 studies measuring clinical outcomes, only 8 reported a significant improvement in clinical outcome. Limitations Despite a common measurement, the meta-analysis was limited by the heterogeneity of the pooled data and the different measures of medication adherence. The funnel plot showed a possible publication bias in studies with high variability of the intervention effect. Conclusions Notwithstanding the statistical heterogeneity among the studies identified, and potential publication bias, the evidence from our meta-analysis suggests that EM-feedback and cognitive-educational interventions are potentially effective approaches to enhance patient adherence to medications. The limitations of this research highlight the urgent need to define guidelines and study characteristics for research protocols that can guide researchers in designing studies to assess the effects of adherence-enhancing interventions. Electronic supplementary material The online version of this article (doi:10.1007/s40265-013-0041-3) contains supplementary material, which is available to authorized users.
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Eberlin M, Otto G, Krämer I. Increased medication compliance of liver transplant patients switched from a twice-daily to a once-daily tacrolimus-based immunosuppressive regimen. Transplant Proc 2013; 45:2314-20. [PMID: 23726723 DOI: 10.1016/j.transproceed.2012.10.037] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2012] [Accepted: 10/09/2012] [Indexed: 10/26/2022]
Abstract
BACKGROUND Compliance with immunosuppressive therapy plays a major role in the long-term success of liver transplantation. Thus, the development of strategies to promote compliance of liver transplant patients and its evaluation over time are of particular interest. OBJECTIVE The main objective of this study was to compare medication compliance rates among liver transplant patients over time after transplantation where switched from a twice- to once-daily tacrolimus-based regimen. METHODS Sixty-five liver transplant patients being administered tacrolimus-based therapy were classified into three subgroups with regard to time posttransplantation. Medication compliance with tacrolimus-based therapy was measured using an electronic medication event monitoring system over a 12-month period: for 6 months tacrolimus was administered twice-daily and for 6 months, once-daily. Dosing, taking, and timing compliance as well as drug holidays were compared intra-individually between twice- and once-daily intake and among the three subgroups. In addition, patient compliance and quality of life were evaluated using questionnaires. RESULTS A per protocol analysis of electronically obtained data showed 63 patients to be eligible. The resulting dosing, taking, and timing compliance rates of the patients were higher during the once-daily dosing period. No significant differences in compliance rates with tacrolimus therapy were observed among three subgroups independent of the dosing regimen. More patients failed the correct timing of the evening compared to the morning dose. Missing doses occurred particularly during weekends. Compliance variables measured by questionnaires (Morisky score, self-report, Medication Experience Scale for Immunosuppressants (MESI) score) and the Hospital Anxiety and Depression Scale score were similar in the two dosing periods. The short-form health survey (SF-36) score was higher with once-daily intake. CONCLUSION The high measured compliance rates did not vary significantly dependent upon the time after transplantation. Nevertheless, compliance rates were greater using once-daily tacrolimus dosing.
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Affiliation(s)
- M Eberlin
- Department of Pharmacy, University Medical Center, Mainz, Germany.
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