Clinical trial NCT03985800: Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Official title: Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease
Behavioral Symptoms
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, New York
name: The Cleveland Clinic
name: Patient-Centered Outcomes Research Institute
First posted: 2019-06-14
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between technology interventions and in-person interventions.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory Bowel Disease Symptom Severity-PROMIS GI
timeFrame: Compare at Baseline, 6-month and 12-month for any changes
measure: Inflammatory Bowel Disease Symptom Severity-HBI
timeFrame: Compare at Baseline, 6-month and 12-month for any changes
measure: Inflammatory Bowel Disease Symptom Severity
timeFrame: Compare at baseline, 6-months and 12-months for any changes
measure: Behavioral Health Symptom Severity
timeFrame: Compare at baseline, 6-month and12-month for any changes
measure: Behavioral Health Symptom Severity
timeFrame: Compare at baseline, 6-month and 12-months for any changes
Secondary outcomes:
measure: Functional Impairment
timeFrame: Compare at baseline, 6-month and 12-month for any changes
measure: Health Care Utilization
timeFrame: Compile and compare at baseline, 6-month and 12-months for any changes
measure: Self-Efficacy
timeFrame: Compare at baseline, 6-month and 12-month for any changes
measure: Inflammatory Bowel Disease- Related Quality of Life
timeFrame: Compare at baseline, 6-month and 12-month for any changes
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Eva Szigethy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: