Inflammatory bowel disease Digestive System
Conditions
Interventions
RAPID-1
Exploring lived experience of diagnostic delay in IBD and optimising the acceptability of a direct-to-public diagnostic pathway.
We will recruit 200 people who have been recently diagnosed w
approximately 20 interviews are expected. These interviews will explore barriers to presentation with gastrointestinal symptoms and the acceptability and distribution of a direct-to-public stool test.
Sponsors
Royal Devon University Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RAPID 1 1. Aged over 16 years 2. Able to give informed consent 3. Diagnosed with inflammatory bowel disease (IBD) within 30 days of study recruitment RAPID 2 (Clinical Cohort) 1. Aged over 16 years 2. Willing and able to give informed consent 3. Diagnosed with likely inflammatory bowel disease within 30 days of study recruitment at Royal Devon University Healthcare NHS Foundation Trust (Exeter and Barnstaple sites), as identified by the clinical care team RAPID 2 (Direct-to-Public Testing Cohort) 1. Aged over 16 years 2. Willing and able to give informed consent 3. Residing within the population served by Royal Devon University Healthcare NHS Foundation Trust 4. Reporting lower gastrointestinal symptoms for more than 2 weeks (including lower abdominal pain below the umbilicus, diarrhoea, or rectal bleeding) 5. No flexible sigmoidoscopy or colonoscopy within the 2 years preceding testing
Exclusion criteria
Exclusion criteria: 1. Those who are under 16 years old 2. Those who are unwilling to consent to the study accepting that researchers will have ongoing access to their primary and secondary care medical record for 1-year after the test for the purpose of follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RAPID 2: Proportion of patients diagnosed with IBD >4 months from symptom onset measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time from symptom onset to IBD diagnosis is measured using patient self-report and electronic health record review at baseline (RAPID 1) 2. Time from symptom onset to first GP presentation (patient delay) is measured using patient self-report at baseline (RAPID 1) 3. Time from first GP presentation to GP referral (primary care delay) is measured using electronic health record review at baseline (RAPID 1) 4. Time from GP referral to IBD diagnosis (secondary care delay) is measured using electronic health record review at baseline (RAPID 1) 5. Barriers and facilitators to early diagnosis are measured using semi-structured qualitative interviews conducted within 4 weeks of diagnosis (RAPID 1) 6. Quality of life is measured using EQ-5D-5L at baseline (RAPID 1) 7. Mood is measured using PHQ-8 and GAD-7 at baseline (RAPID 1) 8. Fatigue is measured using IBD-Fatigue Scale at baseline (RAPID 1) 9. Emergency admission is measured using electronic health record review at 12 and 24 months post-diagnosis (RAPID 1) 10. Surgery is measured using electronic health record review at 12 and 24 months post-diagnosis (RAPID 1) 11. Uptake of direct-to-public stool testing is measured using registration and kit return rates via the online portal during the recruitment period (RAPID 2) 12. Positivity rates of calprotectin and FIT are measured using laboratory analysis of returned stool samples at baseline (RAPID 2) 13. Diagnostic accuracy of calprotectin and FIT is measured using comparison with clinical diagnosis of IBD confirmed by electronic health record review over 12 months (RAPID 2) 14. Cost-effectiveness is measured using health economic modelling based on testing costs, diagnostic yield, and downstream healthcare utilisation over 12 months (RAPID 2) 15. Resource utilisation is measured using electronic health record review of healthcare contacts, investigations, and treatments over 12 months (RAPID 2) 16. Time from symptom onset to IBD diagnosis is measured using patient self | — |
Countries
England, United Kingdom
Contacts
Public ContactClaire Bewshea
Outcome results
None listed