Measurement-based care to improve quality of life and disease management in Veterans with inflammatory bowel disease
Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study
The trial will test whether regularly collecting and acting on Veterans' symptom reports helps people with inflammatory bowel disease feel better and have fewer flares over 12 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 4 sites (Decatur, Georgia and 3 other locations) |
| Trial ID | NCT07210580 on ClinicalTrials.gov |
What this trial studies
This randomized Hybrid Type 1 effectiveness-implementation trial will enroll 250 Veterans with IBD and impaired IBD-specific quality of life and randomize them to measurement-based care (MBC) or enhanced treatment as usual (E-TAU) for 12 months. MBC systematically collects patient-reported outcome (PRO) data between clinic visits and shares that information with care teams to prompt timely, clinician-driven treatment adjustments. The trial compares changes in health-related quality of life and IBD-related events (flares, hospitalizations) and concurrently identifies barriers and facilitators to implementing MBC in routine VA practice. The study is conducted across four VA medical centers and includes clinic staff input to inform real-world implementation.
Who should consider this trial
Good fit: Ideal candidates are Veterans receiving IBD care at one of the participating VA centers who report impaired IBD-specific quality of life (SIBDQ score <60) and can complete study procedures.
Not a fit: Patients with an ostomy or ileal-pouch anal anastomosis or those with severe comorbid medical conditions (for example cancer or transplant) that can confound symptom reporting are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, MBC could help Veterans control symptoms sooner, reduce flares and hospitalizations, and improve day-to-day quality of life.
How similar studies have performed: Measurement-based care has shown benefits in mental health and some chronic diseases, but its effectiveness specifically for IBD has not been well established and is a primary focus of this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria for Veteran patients include: * receiving IBD care at one of the four sites * reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ\<60, as used by others) * willingness and ability to participate in study procedures Clinic staff criteria: * relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland). Exclusion Criteria: Veteran Patient Exclusion criteria: * Presence of an ostomy or ileal-pouch anal anastomosis * Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant). * Exclusions can be readily determined from chart review and a baseline patient assessment Clinic staff exclusion criteria: * Clinic staff without any experience with MBC in IBD.
Where this trial is running
Decatur, Georgia and 3 other locations
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (Not_yet_recruiting)
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (Recruiting)
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Not_yet_recruiting)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Shirley Cohen-Mekelburg, MD MS — VA Ann Arbor Healthcare System, Ann Arbor, MI
- Study coordinator: Shirley Cohen-Mekelburg, MD MS
- Email: Shirley.Cohen-Mekelburg@va.gov
- Phone: (734) 845-5082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.