Recruiting

Measurement-Based Care

Sponsor:

VA Office of Research and Development

Code:

NCT07210580

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MBC-IBD Intervention

Enhanced Treatment as Usual (E-TAU)

Study Details

Brief 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.

Conditions

Inflammatory Bowel Disease

Study ID

NCT07210580

Start date

Mar 9, 2026

Status verified date

Mar, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Dec 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

MBC-IBD Intervention

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. After baseline completion, participants will be asked to complete weekly surveys. These assessments require completion of self-report questionnaires (PROs) 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. Further, patients will receive quarterly reports of their PRO data trends.

Enhanced Treatment as Usual (E-TAU)

E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Participants will also receive educational videos and fact sheets on various IBD-specific topics.

Primary outcome measure

  • Patient-reported Health-related Quality of Life [ Time Frame: Baseline compared to 12 month follow-up. ]

Central Contacts and Locations

Central contacts

Shirley Cohen-Mekelburg, MD MS

(734) 845-5082Shirley.Cohen-Mekelburg@va.gov

Nicolle Marinec, MPH

(734) 845-3653Nicolle.Marinec@va.gov

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Shirley Cohen-Mekelburg, MD MS

(734) 845-5082Shirley.Cohen-Mekelburg@va.gov

Nicolle Marinec, MPH

(734) 845-3653Nicolle.Marinec@va.gov

Principal Investigator:

Shirley Cohen-Mekelburg, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Measurement Based Care
  • Inflammatory Bowel Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-11.