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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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
NOT_YET_RECRUITING
Decatur
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Oregon
VA Portland Health Care System, Portland, OR
NOT_YET_RECRUITING
Portland
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Shirley Cohen-Mekelburg, MD MS
Shirley.Cohen-Mekelburg@va.gov
(734) 845-5082
Backup
Nicolle Marinec, MPH
Nicolle.Marinec@va.gov
(734) 845-3653
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 250
Treatments
Experimental: MBC-IBD
Measurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. These assessments require completion of self-report questionnaires which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires.
Active_comparator: E-TAU
Enhanced Treatment as Usual (E-TAU). Participants assigned to E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Standard of care is based on current evidence-based professional guidelines, including routine inflammatory biomarker assessments (e.g., annual fecal calprotectin), therapy plans, scheduled and as-needed clinic visits, and scheduled and as-needed telephone calls. Participants will also receive educational videos and fact sheets on various IBD-specific topics.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov