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

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03985800
• Other study ID #: STUDY19020176
• Secondary ID: IHS-2017C3-8930
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 30, 2026

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 658
• Est. completion date: September 30, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Symptoms
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Other:
• TEAM
TEAM incorporates team-based care with traditional in-person clinic visits. The care team includes a gastroenterologist, nurse practitioner, nutritionist, social worker/behavioral health specialist, and a psychologist or psychiatrist.
• TECH
TECH uses team-based care similar to TEAM, but in-person care is substituted with telemedicine (i.e., video visits and consultations) and digital behavioral health tools.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Mount Sinai Hospital, New York, Patient-Centered Outcomes Research Institute, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Bowel Disease Symptom Severity-PROMIS GI	Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS GI symptoms scale)	Compare at Baseline, 6-month and 12-month for any changes
Primary	Inflammatory Bowel Disease Symptom Severity-HBI	Harvey Bradshaw Index	Compare at Baseline, 6-month and 12-month for any changes
Primary	Inflammatory Bowel Disease Symptom Severity	Ulcerative Colitis Activity Index	Compare at baseline, 6-months and 12-months for any changes
Primary	Behavioral Health Symptom Severity	Personal Health Questionnaire (PHQ-8)	Compare at baseline, 6-month and12-month for any changes
Primary	Behavioral Health Symptom Severity	General Anxiety Disorder 7 item scale (AD-7)	Compare at baseline, 6-month and 12-months for any changes
Secondary	Functional Impairment	Short Form 12 Health Survey Version 2- (SF12V2)	Compare at baseline, 6-month and 12-month for any changes
Secondary	Health Care Utilization	Composite score of Emergency Department visits, unplanned hospitalizations, surgeries, procedures/imaging	Compile and compare at baseline, 6-month and 12-months for any changes
Secondary	Self-Efficacy	Inflammatory Bowel Disease Self-Efficacy Scale	Compare at baseline, 6-month and 12-month for any changes
Secondary	Inflammatory Bowel Disease- Related Quality of Life	Short Quality of Life in Inflammatory Bowel Disease Questionnaire- SIBDQ	Compare at baseline, 6-month and 12-month for any changes