Faecal Incontinence iNtervention Study
Condition: Fecal Incontinence; Inflammatory Bowel Disease (IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Fecal Incontinence
Study type: Interventional

Summary: 
      Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (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 National Institute for Clinical Excellence (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 six expert centres in the UK, the investigators will perform 3 linked studies: [1] The
      investigators will screen people with IBD, offering the opportunity to obtain help with bowel
      control. The investigators will compare uptake of a postal approach versus response to a
      proactive face-to-face asking approach at a physical or telephone clinical appointment. [2]
      The investigators will conduct a randomised controlled trial (RCT) comparing two different
      approaches (IBD nurse specialist plus self-help booklet versus self-help booklet alone) 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 access the
      nurse intervention at 6 months if they wish, when the RCT is finished. [3] Interviews will be
      performed at the end of the intervention, gathering patient views and preferences and staff
      perspectives via Qualitative interviews and free text questionnaire comments, to enable a
      rich understanding and interpretation of our results.

      The investigators will disseminate the 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.
    

Detailed description: 
      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 Does implementation of the nationally (NICE)-recommended approach to active
      case-finding and step-wise management of FI improve bowel control and quality of life in
      people with IBD.

      The investigators will address 3 objectives:

        1. 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.

        2. 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.

        3. 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 6 UK 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, telephone or face to face approach; and (b)
      Determine currently unmet need for intervention for FI. All hospitals will conduct postal
      case-finding (1000 people) and all will conduct face to face or telephone 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 face to face or telephone 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.
    

Intervention name(s): IBD nurse intervention
Intervention type(s): Other
Intervention description(s): Two IBD nurse specialists at each centre (8 in total) will deliver the IBD nurse intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Fecal Incontinence (FI); Inflammatory bowel disease (IBD); bowel control; Chronic diarrhoea; rectal inflammation