Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease

NCT ID: NCT07210580

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2029-09-30

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.

Detailed Description

Inflammatory bowel disease (IBD) is a chronic autoimmune disorder that affects over 60,000 Veterans and leads to highly symptomatic flares and complications. Close monitoring and timely treatment adjustment 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 systematic solutions to support close between visit monitoring of Veterans with IBD without which they will continue to experience preventable impairment and disability. Measurement-based care (MBC) is a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC works by facilitating early recognition of clinical deterioration and timely clinician-driven treatment adjustment. MBC also increases patients' self-efficacy, their confidence in their ability to handle their symptoms and disease.

This project will use a Hybrid Type 1 effectiveness-implementation randomized trial design (n=250 Veterans with IBD) to test the effectiveness of MBC in IBD versus enhanced treatment as usual (E-TAU) on HRQOL and IBD-related events over 12-months and identify barriers and facilitators to MBC in IBD to inform its implementation in practice. The hypothesis is that at 12-month follow-up, Veterans randomized to MBC will have greater improvement in HRQOL and fewer IBD-related events (composite of flares, emergency department visits, hospitalization, surgery) than E-TAU. The primary objective is to test the effectiveness of MBC vs. E-TAU on key patient outcomes: IBD-specific patient reported HRQOL (primary outcome) and IBD-related events obtained via electronic health record data (secondary outcome). The secondary objective is to assess determinants of MBC in IBD implementation and acceptability with process evaluation.

Conditions

Inflammatory Bowel Disease

Keywords

Measurement Based Care; Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MBC-IBD Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment as Usual (E-TAU)

Intervention Type: OTHER

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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 without any experience with MBC in IBD.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirley Cohen-Mekelburg, MD MS

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Countries

United States

Central Contacts

Shirley Cohen-Mekelburg, MD MS

Role: CONTACT

Phone: (734) 845-5082

Email: Shirley.Cohen-Mekelburg@va.gov

Nicolle Marinec, MPH

Role: CONTACT

Phone: (734) 845-3653

Email: Nicolle.Marinec@va.gov

Facility Contacts

Meena Prasad, MD

Role: primary

Deirdre Dixon

Role: backup

Shirley Cohen-Mekelburg, MD MS

Role: primary

Nicolle Marinec, MPH

Role: backup

Caitlin Citti, MD

Role: primary

Stephanie Unger, MS

Role: backup

Jason Hou, MD

Role: primary

Caroline Lugo, MS

Role: backup

Other Identifiers

824-MR-48366

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1845095

Identifier Type: OTHER

Identifier Source: secondary_id

IIR 24-026

Identifier Type: -

Identifier Source: org_study_id