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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    990
  • sponsor
    University of Pittsburgh
Updated on 12 February 2022
ulcerative colitis
crohn's disease
enteropathy
colitis
ulceration

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.

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.

Details
Condition Inflammatory Bowel Disease, Behavioral Symptoms
Treatment TEAM, TECH
Clinical Study IdentifierNCT03985800
SponsorUniversity of Pittsburgh
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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