TY - JOUR
T1 - Supported Intervention Versus Intervention Alone for Management of Fecal Incontinence in Patients With Inflammatory Bowel Disease
T2 - A Multicenter Mixed-Methods Randomized Controlled Trial
AU - Dibley, Lesley
AU - Hart, Ailsa
AU - Duncan, Julie
AU - Knowles, Charles H
AU - Kerry, Sally
AU - Lanz, Doris
AU - Berdunov, Vladislav
AU - Madurasinghe, Vichithranie W
AU - Wade, Tiffany
AU - Terry, Helen
AU - Verjee, Azmina
AU - Fader, Mandy
AU - Norton, Christine
N1 - Funding Information:
The team acknowledges the assistance of Irene Simmons, the original PCTU project coordinator for this study. This article presents independent research funded by the National Institute for Health. Research (NIHR) under its Research for Patient Benefit (RfPB) Program (grant reference no. PB-PG-0613-31033). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Funding Information:
L.D. has received speaker fees from AbbVie, Dr Falk Pharma, Eli-Lilly (WebMD), Janssen; consultancy fees from GL Assessments and Crohn's & Colitis UK; research funding from Takeda and Janssen.
Publisher Copyright:
Copyright © 2023 by the Wound, Ostomy, and Continence Nurses Society™.
PY - 2023/5/5
Y1 - 2023/5/5
N2 - PURPOSE: The aims of this study were to test a noninvasive self-management intervention supported by specialist nurses versus intervention alone in patients with inflammatory bowel disease (IBD) experiencing fecal incontinence and to conduct a qualitative evaluation of the trial.DESIGN: Multicenter, parallel-group, open-label, mixed-methods randomized controlled trial (RCT).SUBJECTS AND SETTING: The sample comprised patients from a preceding case-finding study who reported fecal incontinence and met study requirements; the RCT was delivered via IBD outpatient clinics in 6 hospitals (5 in major UK cities, 1 rural) between September 2015 and August 2017. Sixteen participants and 11 staff members were interviewed for qualitative evaluation.METHODS: Adults with IBD completed the study activities over a 3-month period following randomization. Each participant received either four 30-minute structured sessions with an IBD clinical nurse specialist and a self-management booklet or the booklet alone. Low retention numbers precluded statistical analysis; individual face-to-face or telephone interviews, recorded digitally and transcribed professionally, were conducted to evaluate the RCT. Transcripts were analyzed thematically using an inductive method.RESULTS: Sixty-seven participants (36%) of the targeted 186 participants were recruited. The groups comprised 32 participants (17% of targeted participants) allocated to the nurse + booklet intervention and 35 (18.8% of targeted participants) allocated to the booklet alone. Less than one-third (n = 21, 31.3%) completed the study. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Participant interviews were conducted concerning study participation and 4 themes emerged that described experiences of patients and staff. These data provided insights into reasons for low recruitment and high attrition, as well as challenges of delivering resource-heavy studies in busy health service environments.CONCLUSIONS: Alternative approaches to trials of nurse-led interventions in hospital settings are needed as many interfering factors may prevent successful completion.
AB - PURPOSE: The aims of this study were to test a noninvasive self-management intervention supported by specialist nurses versus intervention alone in patients with inflammatory bowel disease (IBD) experiencing fecal incontinence and to conduct a qualitative evaluation of the trial.DESIGN: Multicenter, parallel-group, open-label, mixed-methods randomized controlled trial (RCT).SUBJECTS AND SETTING: The sample comprised patients from a preceding case-finding study who reported fecal incontinence and met study requirements; the RCT was delivered via IBD outpatient clinics in 6 hospitals (5 in major UK cities, 1 rural) between September 2015 and August 2017. Sixteen participants and 11 staff members were interviewed for qualitative evaluation.METHODS: Adults with IBD completed the study activities over a 3-month period following randomization. Each participant received either four 30-minute structured sessions with an IBD clinical nurse specialist and a self-management booklet or the booklet alone. Low retention numbers precluded statistical analysis; individual face-to-face or telephone interviews, recorded digitally and transcribed professionally, were conducted to evaluate the RCT. Transcripts were analyzed thematically using an inductive method.RESULTS: Sixty-seven participants (36%) of the targeted 186 participants were recruited. The groups comprised 32 participants (17% of targeted participants) allocated to the nurse + booklet intervention and 35 (18.8% of targeted participants) allocated to the booklet alone. Less than one-third (n = 21, 31.3%) completed the study. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Participant interviews were conducted concerning study participation and 4 themes emerged that described experiences of patients and staff. These data provided insights into reasons for low recruitment and high attrition, as well as challenges of delivering resource-heavy studies in busy health service environments.CONCLUSIONS: Alternative approaches to trials of nurse-led interventions in hospital settings are needed as many interfering factors may prevent successful completion.
KW - Adult
KW - Humans
KW - Fecal Incontinence/complications
KW - Inflammatory Bowel Diseases/complications
KW - Patients
KW - Research Design
UR - http://www.scopus.com/inward/record.url?scp=85159362182&partnerID=8YFLogxK
U2 - 10.1097/WON.0000000000000979
DO - 10.1097/WON.0000000000000979
M3 - Article
C2 - 37146115
SN - 1071-5754
VL - 50
SP - 235
EP - 244
JO - Journal of Wound, Ostomy, & Continence Nursing
JF - Journal of Wound, Ostomy, & Continence Nursing
IS - 3
ER -