Specialty Medical Homes for IBD and Behavioral Health Conditions

Overseen By Jessica Meyers, MS Ed

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No smartphone, English proficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

658 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment TEAM, TECH for IBD and Behavioral Health Conditions?

Research shows that specialty medical homes, which involve a team of specialists managing chronic diseases like inflammatory bowel disease (IBD), can reduce unplanned care, decrease disease activity, and improve quality of life for patients. ^{1 2 3 4 5}

How is the Specialty Medical Home treatment for IBD and Behavioral Health Conditions different from other treatments?

The Specialty Medical Home (SMH) treatment is unique because it provides a multidisciplinary, patient-centered approach specifically for chronic diseases like inflammatory bowel disease (IBD). This model focuses on comprehensive, coordinated care involving specialists, which can lead to reduced unplanned care, lower disease activity, and improved quality of life compared to traditional care models. ^{1 2 4 5 6}

What is the purpose of this trial?

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.

Research Team

Eva Szigethy, MD, PhD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

This trial is for individuals with Inflammatory Bowel Disease (IBD), such as Crohn's or Ulcerative Colitis, who also have mild to severe behavioral health symptoms. Participants must score at least a 6 on the PHQ4 questionnaire. People without a smartphone or those unable to speak, read, or understand English well enough are not eligible.

Inclusion Criteria

I have mild to severe behavioral health symptoms.

I have been diagnosed with Crohn's disease or Ulcerative Colitis.

Exclusion Criteria

Unable to speak, read or understand English at the minimum-required level.

Lack of smart phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TEAM-care or TECH-telehealth approach for managing IBD and BH conditions

12 months

1 visit (in-person) per year, additional visits as needed, technology-supported interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• TEAM
• TECH

Trial Overview The study compares two strategies for managing IBD and behavioral health: in-person supported care versus technology-supported care. It uses a randomized design and collects both quantitative data (like self-reports) and qualitative data (such as interviews).

Participant Groups

Group I: TEAM-care as usual approach Active Control 1 Intervention

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

Group II: TECH-telehealth approach Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

References

1. England pubmed.ncbi.nlm.nih.gov

The Inflammatory Bowel Disease Medical Home: From Patients to Populations. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Care in an Interdisciplinary Inflammatory Bowel Disease Specialty Clinic on Outcomes in Patients Insured with Medicaid. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Gastroenterologists' attitudes and self-reported practices regarding inflammatory bowel disease. [2018]

4. England pubmed.ncbi.nlm.nih.gov

The Inflammatory Bowel Disease Specialty Medical Home: A New Model of Patient-centered Care. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Reduced Unplanned Care and Disease Activity and Increased Quality of Life After Patient Enrollment in an Inflammatory Bowel Disease Medical Home. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The Pediatric Inflammatory Bowel Disease Medical Home: A Proposed Model. [2022]