Randomized Clinical Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jun 27, 2023; 15(6): 826-840
Published online Jun 27, 2023. doi: 10.4254/wjh.v15.i6.826
Randomized intervention and outpatient follow-up lowers 30-d readmissions for patients with hepatic encephalopathy, decompensated cirrhosis
Antoinette Pusateri, Kevin Litzenberg, Claire Griffiths, Caitlin Hayes, Bipul Gnyawali, Michelle Manious, Sean G Kelly, Lanla F Conteh, Sajid Jalil, Haikady N Nagaraja, Khalid Mumtaz
Antoinette Pusateri, Claire Griffiths, Caitlin Hayes, Sean G Kelly, Sajid Jalil, Khalid Mumtaz, Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, OH 43210, United States
Kevin Litzenberg, Michelle Manious, Division of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH 43210, United States
Bipul Gnyawali, The Ohio State University College of Medicine, The Ohio State University Wexner Medical Center, Columbus, OH 43210, United States
Lanla F Conteh, Division of Gastroenterology and Hepatology, The Ohio State Wexner Medical Center, Columbus, OH 43210, United States
Haikady N Nagaraja, Division of Biostatistics, The Ohio State University, Columbus, OH 43210, United States
Author contributions: Pusateri A and Mumtaz K study design, team administration, training team members for recruiting, recruiting patients for study, interpreting data, drafting manuscript; both approved the final submitted version of this manuscript; Litzenberg K, Griffiths C, Hayes C, Gnyawali B and Manious M recruiting patients for study, drafting manuscript, approved the final submitted version of manuscript; Jalil S, Kelly S and Conteh L reviewed and edited the final draft of the manuscript; Nagaraja K analyzed data, edited manuscript, and approved the final submitted version of this manuscript.
Supported by GASTR29: Prospective validation of readmission risk score and interventions to prevent readmission in patients with decompensated cirrhosis (CCTS ID#: 6018).
Institutional review board statement: This study was conducted at the Ohio State University Wexner Medical Center (OSUWMC), Columbus, Ohio from July 2019 to December 2020. Our study was approved by OSUWMC Institutional Review Board. All aspects of the studying involving human participants including informed consent for enrollment were in accordance with the ethical standards of our Institutional Review Board and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Clinical trial registration statement: Since our randomized trial was of a nursing intervention only, it was not an official randomized control clinical trial that needed registering on a national level.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Antoinette Pusateri, MD, Doctor, Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, 2nd Floor Doan Office Tower 395 W. 12th Avenue, Columbus, OH 43210, United States. antoinette.pusateri@osumc.edu
Received: December 22, 2022
Peer-review started: December 22, 2022
First decision: February 14, 2023
Revised: March 23, 2023
Accepted: April 14, 2023
Article in press: April 14, 2023
Published online: June 27, 2023
Processing time: 185 Days and 2.3 Hours
Abstract
BACKGROUND

We previously reported national 30-d readmission rates of 27% in patients with decompensated cirrhosis (DC).

AIM

To study prospective interventions to reduce early readmissions in DC at our tertiary center.

METHODS

Adults with DC admitted July 2019 to December 2020 were enrolled and randomized into the intervention (INT) or standard of care (SOC) arms. Weekly phone calls for a month were completed. In the INT arm, case managers ensured outpatient follow-up, paracentesis, and medication compliance. Thirty-day readmission rates and reasons were compared.

RESULTS

Calculated sample size was not achieved due to coronavirus disease 2019; 240 patients were randomized into INT and SOC arms. 30-d readmission rate was 33.75%, 35.83% in the INT vs 31.67% in the SOC arm (P = 0.59). The top reason for 30-d readmission was hepatic encephalopathy (HE, 32.10%). There was a lower rate of 30-d readmissions for HE in the INT (21%) vs SOC arm (45%, P = 0.03). There were fewer 30-d readmissions in patients who attended early outpatient follow-up (n = 17, 23.61% vs n = 55, 76.39%, P = 0.04).

CONCLUSION

Our 30-d readmission rate was higher than the national rate but reduced by interventions in patients with DC with HE and early outpatient follow-up. Development of interventions to reduce early readmission in patients with DC is needed.

Keywords: Decompensated cirrhosis; Hospital readmissions; Interventions

Core Tip: Our 30-d readmission rate was higher than the national rate but reduced by interventions in patients with decompensated cirrhosis (DC) with hepatic encephalopathy and early outpatient follow-up. Development of interventions to reduce early readmission in patients with DC is needed.