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

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ClinicalTrials.gov Identifier: NCT03985800
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Mount Sinai Hospital, New York
The Cleveland Clinic
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Eva Szigethy, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Behavioral Symptoms Other: TEAM Other: TECH Not Applicable

Detailed 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 (remote monitoring, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison between technology interventions and in-person interventions.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : July 31, 2023

Arm Intervention/treatment
Active Comparator: TEAM-care as usual approach
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
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.

Active Comparator: TECH-telehealth approach
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
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.




Primary Outcome Measures :
  1. Inflammatory Bowel Disease Symptom Severity-PROMIS GI [ Time Frame: Compare at Baseline, 6-month and 12-month for any changes ]
    Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS GI symptoms scale)

  2. Inflammatory Bowel Disease Symptom Severity-HBI [ Time Frame: Compare at Baseline, 6-month and 12-month for any changes ]
    Harvey Bradshaw Index

  3. Inflammatory Bowel Disease Symptom Severity [ Time Frame: Compare at baseline, 6-months and 12-months for any changes ]
    Ulcerative Colitis Activity Index

  4. Behavioral Health Symptom Severity [ Time Frame: Compare at baseline, 6-month and12-month for any changes ]
    Personal Health Questionnaire (PHQ-8)

  5. Behavioral Health Symptom Severity [ Time Frame: Compare at baseline, 6-month and 12-months for any changes ]
    General Anxiety Disorder 7 item scale (AD-7)


Secondary Outcome Measures :
  1. Functional Impairment [ Time Frame: Compare at baseline, 6-month and 12-month for any changes ]
    Short Form 12 Health Survey Version 2- (SF12V2)

  2. Health Care Utilization [ Time Frame: Compile and compare at baseline, 6-month and 12-months for any changes ]
    Composite score of Emergency Department visits, unplanned hospitalizations, surgeries, procedures/imaging

  3. Self-Efficacy [ Time Frame: Compare at baseline, 6-month and 12-month for any changes ]
    Inflammatory Bowel Disease Self-Efficacy Scale

  4. Inflammatory Bowel Disease- Related Quality of Life [ Time Frame: Compare at baseline, 6-month and 12-month for any changes ]
    Short Quality of Life in Inflammatory Bowel Disease Questionnaire- SIBDQ



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985800


Contacts
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Contact: Michelle Sloane, MSW 412-454-4019 sloanem@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Eva Szigethy, MD, PhD    412-802-6696    szigethye@upmc.edu   
Principal Investigator: Eva Szigethy, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
Mount Sinai Hospital, New York
The Cleveland Clinic
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Eva Szigethy, MD, PhD University of Pittsburgh Medical Center

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Responsible Party: Eva Szigethy, Professor of Psychiatry and Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03985800     History of Changes
Other Study ID Numbers: IHS-2017C3-8930
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared. Data is shared at the aggregate level

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Behavioral Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases