Measurement-based care to improve quality of life and disease management in Veterans with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• VA Ann Arbor Healthcare System, Ann Arbor, MI
  Ann Arbor, Michigan, United States Recruiting
• Atlanta VA Medical and Rehab Center, Decatur, GA
  Decatur, Georgia, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.