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

University of Pittsburgh

Status: Completed

Conditions: Inflammatory Bowel Disease; Behavioral Symptoms

Treatments: Other: TEAM; Other: TECH

Study type: Interventional

Funder types: Other

Identifiers

NCT03985800

IHS-2017C3-8930

STUDY19020176

Details and patient eligibility

About

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.

Full 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.

Primary outcomes are composite scores of measures focused on 1) IBD Symptom Severity, and 2) BH Symptom Severity. IBD Symptom Severity is measured via a composite IBD Complexity Score involving responses to two patient-reported scales: the PROMIS-GI measure and either the Harvey Bradshaw Index (for participants with Crohn's disease) or ulcerative colitis activity index (for participants with ulcerative colitis). BH Symptom Severity was measured utilizing the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS), a composite of two patient-reported scale for measuring anxiety (Generalized Anxiety Disorder scale (GAD-7) and depression (Patient Health Questionnaire depression scale (PHQ-8). Scales are further defined in Results, Outcome Measures.

Enrollment: 657 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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657 participants in 2 patient groups

TEAM-care as usual approach

Active Comparator group

Description:

Patients will be triaged based on their physical health (PH) and behavioral health (BH) complexity to determine the frequency of in-person visits and how much of these visits will be devoted to medical versus BH issues. Minor modifications were made to the TEAM approach during the COVID-19 public health emergency to account for reduced face-to-face time without changing the underlying differentiation between the two models of delivering SMH care.

Treatment:

Other: TEAM

TECH-telehealth approach

Active Comparator group

Description:

Each patient will have an initial face-to-face visit with the core treatment team described above and undergo the same triage process to determine their PH/BH care needs. Each TECH patient will participate in one face-to-face treatment team visit per year unless more frequent visits are deemed to be medically necessary; however, all other interactions will be conducted via technology-supported modalities

Treatment:

Other: TECH