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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammatory Bowel Disease, Behavioral Symptoms

Intervention / Treatment
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* Other: TEAM
* Other: TECH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between technology interventions and in-person interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEAM-care as usual approach<br>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 | Other: TEAM<br>* 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.<br>|
| Active Comparator: TECH-telehealth approach<br>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 | Other: TECH<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Inflammatory Bowel Disease Symptom Severity-HBI | Harvey Bradshaw Index | Compare at Baseline, 6-month and 12-month for any changes | 
| Inflammatory Bowel Disease Symptom Severity | Ulcerative Colitis Activity Index | Compare at baseline, 6-months and 12-months for any changes | 
| Behavioral Health Symptom Severity | Personal Health Questionnaire (PHQ-8) | Compare at baseline, 6-month and12-month for any changes | 
| Behavioral Health Symptom Severity | General Anxiety Disorder 7 item scale (AD-7) | Compare at baseline, 6-month and 12-months for any changes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Impairment | Short Form 12 Health Survey Version 2- (SF12V2) | Compare at baseline, 6-month and 12-month for any changes | 
| 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 | 
| Self-Efficacy | Inflammatory Bowel Disease Self-Efficacy Scale | Compare at baseline, 6-month and 12-month for any changes | 
| 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 |