Randomized Controlled Trial
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 21, 2020; 26(47): 7568-7583
Published online Dec 21, 2020. doi: 10.3748/wjg.v26.i47.7568
Evaluation of an educational telephone intervention strategy to improve non-screening colonoscopy attendance: A randomized controlled trial
Agustín Seoane, Xènia Font, Juan C Pérez, Rocío Pérez, Carlos F Enriquez, Miriam Parrilla, Faust Riu, Josep M Dedeu, Luis E Barranco, Xavier Duran, Inés A Ibáñez, Marco A Álvarez
Agustín Seoane, Xènia Font, Juan C Pérez, Rocío Pérez, Carlos F Enriquez, Miriam Parrilla, Faust Riu, Josep M Dedeu, Luis E Barranco, Inés A Ibáñez, Marco A Álvarez, Digestive Department, Endoscopy Unit, Hospital del Mar, Parc de Salut Mar, Barcelona 08003, Spain
Agustín Seoane, Faust Riu, Josep M Dedeu, Luis E Barranco, Marco A Álvarez, Colorectal Cancer Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona 08003, Spain
Josep M Dedeu, Marco A Álvarez, Department of Medicine, Autonomous University of Barcelona, Barcelona 08003, Spain
Xavier Duran, Consulting Service on Methodology for Biomedical Research, IMIM (Hospital del Mar Medical Research Institute), Barcelona 08003, Spain
Author contributions: Seoane A contributed to conception and designed of the study, analysis and interpretation of data; Font X, Pérez JC, Pérez R, Enriquez CF and Parrilla M contributed to acquisition of data; Duran X contributed to the statistical analysis; Riu F, Dedeu JM, Barranco LE, Ibáñez IA and Álvarez MA contributed making critical revisions and related to important intellectual content of the manuscript.
Supported by Hospital del Mar, Parc de Salut Mar.
Institutional review board statement: The study was approved by the ethics committee of IMIM, Hospital del Mar Medical Research Institute (7739/I).
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov/ct2/show/NCT03458377. The registration identification number is NCT03458377.
Informed consent statement: All involved persons (subjects and legally authorized representatives) gave their written informed consent.
Conflict-of-interest statement: There are no conflicts of interest for any of the authors.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Agustín Seoane, MD, Attending Doctor, Research Scientist, Digestive Department, Endoscopy Unit, Hospital del Mar, Parc de Salut Mar, Passeig Marítim, 25-29, Barcelona 08003, Spain. 92847@parcdesalutmar.cat
Received: September 15, 2020
Peer-review started: September 15, 2020
First decision: November 3, 2020
Revised: November 16, 2020
Accepted: November 29, 2020
Article in press: November 29, 2020
Published online: December 21, 2020
Research background

Educative interventions with bidirectional contact to the patient have shown to improve colonoscopy attendance in colorectal cancer population screening programmes and because of its huge clinical and economic impact, they have been widely implemented. However, outside of this population programmes, educative measures to improve colonoscopy attendance have been poorly studied and no navigation interventions are usually performed.

Research motivation

We thought this lack of research needed attention, so we designed a randomized controlled trial to conduct an educational telephone nurse intervention with bidirectional contact directed to increase colonoscopy attendance, similar to the patient navigation carried out in the population screening setting.

Research objectives

The aim of the study was to determine the clinical and economic impact of this educational intervention.

Research methods

We included all consecutive outpatients referred for colonoscopy from primary care centres in our health area. Patients randomized to the intervention group received a telephone call 7 d before colonoscopy appointment to eliminate socioeconomic, psychological and clinical barriers that could affect attendance. Baseline characteristics including demographics, clinical and endoscopic factors previously reported to be related to non-attendance were collected. The primary outcome was the attendance rate. The secondary outcomes included the economic impact and the potential benefit of the intervention in regard to compliance with patient preparedness protocols, cleansing adequacy, and patient satisfaction. We performed an intention-to-treat (ITT) and per-protocol (PP) analysis to measure the applicability of the telephone intervention.

Research results

A total of 738 and 746 patients were finally included in the intervention and control group (CG) respectively. Six hundred thirteen (83%) patients were contacted in the intervention group (IG). The non-attendance rate was lower in the IG, both in the ITT analysis (IG 8.4% vs CG 14.3%, P < 0.001) and in the PP analysis (4.4% vs 14.3%, P < 0.001). In a multivariable analysis, belonging to the CG increased the risk of non-attendance in both, the ITT analysis (OR 1.81, 95%CI: 1.27 to 2.58, P = 0.001) and the PP analysis (OR 3.56, 95%CI: 2.25 to 5.64, P < 0.001). There was also a significant difference in compliance with preparedness protocols [bowel cleansing: IG 61.7% vs CG 52.6% (P = 0.001), antithrombotic management: IG 92.5% vs CG 62.8% (P = 0.001), and sedation scheduling: IG 78.8% vs CG 0% (P ≤ 0.001)]. We observed a net benefit of €55600/year after the intervention. The information given before the procedure was rated as excellent by 26% (CG) and 51% (IG) of patients, P ≤ 0.001.

Research conclusions

According to our results, non-attendance has a significant clinical and economic impact outside the population screening setting. This study proposes the necessity to routinely incorporate attendance measures into endoscopy units, not only in the population screening programmes but also in all colonoscopies. A telephone educative intervention by an endoscopy nurse seems to be a valid method.

Research perspectives

Further multicentric studies on attendance outside colorectal cancer population screening programmes are needed. The type and percentage of undiagnosed pathology and the prognostic and therapeutic implications of the diagnostic delay in these patients have to be studied. We also do not know the effect that the intervention could have on attending future colonoscopies although the satisfaction results observed in our study are promising in this regard.