Specialty Medical Homes for IBD and Behavioral Health Conditions

Overseen by Eva Szigethy, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pittsburgh

No Placebo Group

Trial Summary

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

Treatment Details

Interventions

• TEAM (Behavioural Intervention)
• TECH (Behavioural Intervention)

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+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE