Dibley, Lesley ORCID: https://orcid.org/0000-0001-7964-7672, Hart, Ailsa, Duncan, Julie, Knowles, Charles H, Kerry, Sally, Lanz, Doris, Berdunov, Vladislav, Madurasinghe, Vichithranie W, Wade, Tiffany, Terry, Helen, Verjee, Azmina, Fader, Mandy and Norton, Christine (2023) Supported intervention versus intervention alone for management of fecal incontinence in patients with Inflammatory Bowel Disease: a multicentre randomised controlled trial with qualitative evaluation. Journal of Wound, Ostomy and Continence Nursing, 50 (3). pp. 235-244. ISSN 1071-5754 (Print), 1528-3976 (Online) (doi:10.1097/WON.0000000000000979)

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Abstract

ABSTRACT
Purpose To test a non-invasive self-management intervention supported by specialist nurses against the intervention alone in patients with Inflammatory Bowel Disease (IBD) with fecal incontinence and to conduct a qualitative evaluation of the trial.
Design Multicentre parallel group randomised controlled open label trial, with qualitative evaluation.
Subjects and Setting: Patients from a preceding case-finding study who had reported fecal incontinence and met the study requirements participated in the RCT, delivered via IBD outpatient clinics in six UK hospitals. Sixteen participants and 11 staff were interviewed for the qualitative evaluation.
Methods
Over a three-month period, participants received either four 30-minute 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 analysed thematically using an inductive method.
Results
RCT: 67 participants of the target of 186 were recruited (nurse + booklet: n=32; booklet alone: n=35) and 21 completed the study. Forty-six participants were lost to follow-up or withdrawn. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Interviews: four themes described the experiences of patient participants and of staff, and provided insight into reasons for low recruitment and attrition, and the difficulties of delivering resource-heavy studies in busy health service environments.
Conclusions
Alternative approaches to trials of nurse-led interventions in hospital settings are needed.

Item Type:	Article
Uncontrolled Keywords:	attrition; fecal incontinence; inflammatory bowel disease; nurse-led intervention
Subjects:	R Medicine > R Medicine (General) R Medicine > RB Pathology R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Faculty / School / Research Centre / Research Group:	Faculty of Education, Health & Human Sciences Faculty of Education, Health & Human Sciences > Institute for Lifecourse Development Faculty of Education, Health & Human Sciences > Institute for Lifecourse Development > Centre for Chronic Illness and Ageing
Last Modified:	01 May 2024 01:38
URI:	http://gala.gre.ac.uk/id/eprint/41449

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