Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions

Not Applicable

Active, not recruiting

• Conditions: Inflammatory Bowel Disease; Behavioral Symptoms

• Registration Number: NCT03985800
• Lead Sponsor: University of Pittsburgh

Brief Summary

A comparative effectiveness study using an individual-level randomized design along with a pragmatic, mixed-methods approach to compare two strategies (e.g. in-person supported care, technology-supported care) all of which include evidence-based components for delivering IBD and BH care. Quantitative (e.g. self-report, electronic health record, process) and qualitative (e.g., interviews) data will be collected across multiple time points during the study period.

Detailed Description

The investigators propose to conduct a comparative effectiveness research (CER) study of two evidence-based, patient-centered approaches implemented within an existing Specialty Medical Home (SMH) model: TEAM, an in-person, multidisciplinary team-based approach delivered at point of care and TECH, a technology-based (digital therapeutics, and telehealth) approach delivered at the patient's convenience with the guidance of health coaches. Both are designed to support care for adult patients with complex, chronic health conditions and behavioral health (BH) disorders, and will be tested in three of the nation's largest and most established SMHs for inflammatory bowel disease (IBD). IBD serves as an exemplary chronic disease model where untreated BH issues have been associated with poor medical outcomes.

Study Timeline

• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-14
• Study Start: 2019-07-01
• Primary Completion: 2025-03-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

• Inflammatory Bowel Disease Diagnosis of Crohn's or Ulcerative Colitis. Behavioral health symptoms mild to severe, defined as a score of >= 6 on the Personal Health Questionnaire 4 (PHQ4)

Exclusion Criteria

• Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Behavioral Health Symptom Severity	Compare at baseline, 6-month and 12-months for any changes	General Anxiety Disorder 7 item scale (AD-7)
Inflammatory Bowel Disease Symptom Severity-PROMIS GI	Compare at Baseline, 6-month and 12-month for any changes	Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS GI symptoms scale)
Inflammatory Bowel Disease Symptom Severity-HBI	Compare at Baseline, 6-month and 12-month for any changes	Harvey Bradshaw Index
Inflammatory Bowel Disease Symptom Severity	Compare at baseline, 6-months and 12-months for any changes	Ulcerative Colitis Activity Index

Secondary Outcome Measures

Name	Time	Method
Inflammatory Bowel Disease- Related Quality of Life	Compare at baseline, 6-month and 12-month for any changes	Short Quality of Life in Inflammatory Bowel Disease Questionnaire- SIBDQ
Health Care Utilization	Compile and compare at baseline, 6-month and 12-months for any changes	Composite score of Emergency Department visits, unplanned hospitalizations, surgeries, procedures/imaging
Self-Efficacy	Compare at baseline, 6-month and 12-month for any changes	Inflammatory Bowel Disease Self-Efficacy Scale
Functional Impairment	Compare at baseline, 6-month and 12-month for any changes	Short Form 12 Health Survey Version 2- (SF12V2)

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States