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

NCT03985800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2025-09-03

Study results available
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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.

Conditions

Interventions

OTHER

TEAM

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.

OTHER

TECH

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.

Sponsors & Collaborators

  • Mount Sinai Hospital, New York

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Eva Szigethy, MD, PhD · University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2025-03-28
Completion
2025-03-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985800 on ClinicalTrials.gov