Title: Improving continence in people with inflammatory bowel disease: active case finding and a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Background Inflammatory bowel disease (IBD) affects approximately 250,000 UK adults. It causes symptoms including diarrhoea and extreme faecal urgency and has an unpredictable relapsing-remitting course. A quarter of people with IBD report faecal incontinence (FI) and two-thirds have urgency, even when IBD is in remission. Although this limits peoples lives, most do not seek professional help. No study has determined whether nationally-recommended approaches to FI would help people with IBD. Research question We wish to conduct the first major intervention study for people with FI associated with IBD with the broad aim of determining whether implementation of the nationally (NICE)-recommended approach to active case-finding and step-wise management of FI will improve bowel control and quality of life in people with IBD. We will address 3 objectives: To implement active case finding for FI and life-restricting faecal urgency in people with IBD, monitoring uptake of the offer of help and investigating barriers to accessing care. To determine the effectiveness of implementing the algorithm of care proposed by NICE for people with FI in a randomised controlled trial compared to provision of the same information in a self-management booklet. The trial will measure the effects of each intervention at 6 months after completion of the intervention. To obtain detailed qualitative feedback from patients and staff on the best way of enabling health-seeking, the experience of the intervention and suggestions for future service developments. Plan of investigation We will conduct research in 4 London specialist IBD services, in two phases with an integral qualitative element. Phase 1: active case finding: will (a) Compare active case finding rates of disclosure for FI as recommended by NICE by using a postal or face to face approach; and (b) Determine currently unmet need for intervention for FI. Two hospitals will conduct postal case-finding (5000 people) and two will conduct face to face questioning (1000 people) to compare numbers reporting FI and uptake of offer of intervention. Phase 2: randomised controlled trial 186 patients with IBD and FI will be recruited (from people wanting help in Phase 1) to a parallel multicentre RCT comparing 2 interventions: (a) CONSULT + BOOKLET: 3-4 consultations with an IBD specialist nurse who has received extra training on FI plus provision of a booklet developed with IBD patients on self-help for FI; (b) BOOKLET: intervention is booklet alone. A series of questionnaire-based outcomes will be recorded at 6 months after intervention: FI: measures including primary outcome the St Mark s faecal incontinence score at 6 months and individual symptom frequencies; Other bowel symptoms; Disease-specific and general quality of life; Anxiety and depression. Data will be managed and analysed by the Pragmatic Clinical Trials Unit (registered CTU). Analysis will be performed on intent to treat. Qualitative study: Interviews will explore patient, IBD nurse and service managers views on the interventions and ways to deliver these in the NHS. Potential benefit to patients and the NHS People with IBD and FI have told us that they often lead very restricted lives, many withdrawing from social and economic activity. There is also currently a lack of openness about FI, with clinicians not asking and patients not complaining. This study will bring this issue into the open for both clinicians and patients and provide answers to the question of how to approach asking about FI. It will also produce evidence to inform service development and clinical intervention. We have worked closely with patients in developing this application and will continue to do so in conduct, analysis and dissemination of the research.

Lay abstract: Inflammatory Bowel Disease (IBD) affects 250,000 adults in the UK and causes bouts of diarrhoea which are hard to control. Over a quarter of patients experience extremely distressing faecal incontinence (FI). Even when the disease is in remission, the majority of patients live in fear of not finding a toilet in time. This curtails their activities and quality of life. The NHS (NICE 2007) has issued national guidance on actively asking patients about FI and a step-wise care plan for managing FI. However, this has not been evaluated in people with IBD, the vast majority of whom do not ask for help, even when they have frequent FI. Across four expert centres in London, we will perform 3 linked studies: [1] We will screen people with IBD, offering the opportunity to obtain help with bowel control. We will compare uptake of a postal approach versus response to a proactive face-to-face asking approach at a clinical appointment. [2] We will conduct a randomised trial (comparison) of two different approaches (IBD nurse-specialist-led intervention versus provision of a self-help booklet) to see which one produces the best results in terms of reductions in FI, other symptoms, costs and quality of life at 6 months after intervention. Booklet group participants may cross over to the nurse intervention at 6 months if they wish. [3] Interviews will be performed throughout, gathering patient views and preferences and staff perspectives via interviews and free text questionnaire comments, to enable a rich understanding and interpretation of our results. We will disseminate our results widely to people with IBD and health professionals and take active steps to embed successful interventions in NHS services, having gained sound evidence on how many people want help, whether intervention is effective in improving FI, and patient and staff views on interventions.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: ORAL AND GASTROINTESTINAL