Inflammatory Bowel Disease Digestive System Inflammatory Bowel Disease
Conditions
Interventions
The OPTIMISE Study will test a checklist and algorithm designed to find any medical issues which may be causing IBD-related symptoms of fatigue, pain or urgency and to ensure these are being treated a
Sponsors
London North West Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of IBD (including patients with an ileo-anal pouch or stoma) 2. 18 years and over 3. Lives in UK and attends one of the IBD-BOOST NHS clinical sites for routine IBD care 4. Has completed the IBD-BOOST survey (stage 2) and indicated that they would like further support to help manage their symptoms 5. Ability to give informed consent and sufficient command of English to understand study documents and procedures will be assumed from response to previous survey
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with any of the following detected via the OPTIMISE checklist, faecal calprotectin test or by the nurse/clinician following the algorithm 1. “Red flags” (indicating an urgent or serious medical issue) on checklist which require investigation 2. Active disease (defined as faecal calprotectin 200 or over and/or IBD control score 13 or under) 3. Abnormalities detected on blood test in people with fatigue 4. Irritable Bowel Syndrome or functional dyspepsia diagnosed in people with pain (by responses on checklist) 5. Untreated loose stool detected in people with urgency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants for whom a clinical intervention was indicated using the OPTIMISE checklist 2. Proportion of participants who declined a suggested clinical intervention 3. Proportion of participants starting a clinical intervention for these 3 symptoms 4. For those starting a clinical optimisation intervention, the cost of implementing the algorithm (clinical tests or intervention and nurse/clinician time to implement the algorithm) 5. The checklist also includes the following measures, which will be repeated at 3 months: 5.1. PROMIS Short Form v1.0 – Fatigue 4a; 4 item validated scale to measure fatigue 5.2. PROMIS Scale v1.0 - Pain Intensity 3a; 3 item validated scale to measure pain 5.3. PROMIS Scale v1.0 – Gastrointestinal Bowel Incontinence 4a; 4 item validated scale to measure bowel control 5.4. IBD-Control score; 8-item self-reported score to measure disease control from the patient's perspective 5.5. EQ-5D-5L (Quality of Life measurement); a 5-item standardised measure of health 6. Only those participants needing interventions as indicated by the algorithm, will be sent the outcome questionnaire at 3 months after return of the initial checklist and stool sample. This questionnaire will also include a free text feedback option at follow up to capture qualitative comments about the experience of completing the checklist and algorithm, and how onerous or helpful this was. 7. In addition, the nurse/clinician will complete the Optimisation CRF for each participant, this will include number of visits or telephone contacts, all tests and results and all management initiated within the algorithm. Qualitative comments on taking the participant through the process of using the checklist and algorithm will be collected here. 8. Feasibility outcomes will include number consenting but then discontinuing (with reasons if possible), completion of outcome measures, completion of CRFs. | — |
Countries
England, United Kingdom
Contacts
Public ContactChristine Norton
Outcome results
None listed