Authors

  1. Dibley*, Lesley
  2. Hart, Ailsa
  3. Duncan*, Julie
  4. Knowles, Charles H.
  5. Kerry, Sally
  6. Lanz*, Doris
  7. Berdunov*, Vladislav
  8. Madurasinghe*, Vichithranie W.
  9. Wade, Tiffany
  10. Terry, Helen
  11. Verjee, Azmina
  12. Fader, Mandy
  13. Norton, Christine

Abstract

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.