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

Primary Purpose

Inflammatory Bowel Disease, Behavioral Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAM
TECH
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TEAM-care as usual approach

TECH-telehealth approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

Inflammatory Bowel Disease Symptom Severity-PROMIS GI
Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS GI symptoms scale)
Inflammatory Bowel Disease Symptom Severity-HBI
Harvey Bradshaw Index
Inflammatory Bowel Disease Symptom Severity
Ulcerative Colitis Activity Index
Behavioral Health Symptom Severity
Personal Health Questionnaire (PHQ-8)
Behavioral Health Symptom Severity
General Anxiety Disorder 7 item scale (AD-7)

Secondary Outcome Measures

Functional Impairment
Short Form 12 Health Survey Version 2- (SF12V2)
Health Care Utilization
Composite score of Emergency Department visits, unplanned hospitalizations, surgeries, procedures/imaging
Self-Efficacy
Inflammatory Bowel Disease Self-Efficacy Scale
Inflammatory Bowel Disease- Related Quality of Life
Short Quality of Life in Inflammatory Bowel Disease Questionnaire- SIBDQ

Full Information

First Posted
May 28, 2019
Last Updated
September 8, 2023
Sponsor
University of Pittsburgh
Collaborators
Mount Sinai Hospital, New York, The Cleveland Clinic, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03985800
Brief Title
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Official Title
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Mount Sinai Hospital, New York, The Cleveland Clinic, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Behavioral Symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison between technology interventions and in-person interventions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
990 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAM-care as usual approach
Arm Type
Active Comparator
Arm Description
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
Arm Title
TECH-telehealth approach
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
TEAM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TECH
Intervention Description
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 Measure Information:
Title
Inflammatory Bowel Disease Symptom Severity-PROMIS GI
Description
Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS GI symptoms scale)
Time Frame
Compare at Baseline, 6-month and 12-month for any changes
Title
Inflammatory Bowel Disease Symptom Severity-HBI
Description
Harvey Bradshaw Index
Time Frame
Compare at Baseline, 6-month and 12-month for any changes
Title
Inflammatory Bowel Disease Symptom Severity
Description
Ulcerative Colitis Activity Index
Time Frame
Compare at baseline, 6-months and 12-months for any changes
Title
Behavioral Health Symptom Severity
Description
Personal Health Questionnaire (PHQ-8)
Time Frame
Compare at baseline, 6-month and12-month for any changes
Title
Behavioral Health Symptom Severity
Description
General Anxiety Disorder 7 item scale (AD-7)
Time Frame
Compare at baseline, 6-month and 12-months for any changes
Secondary Outcome Measure Information:
Title
Functional Impairment
Description
Short Form 12 Health Survey Version 2- (SF12V2)
Time Frame
Compare at baseline, 6-month and 12-month for any changes
Title
Health Care Utilization
Description
Composite score of Emergency Department visits, unplanned hospitalizations, surgeries, procedures/imaging
Time Frame
Compile and compare at baseline, 6-month and 12-months for any changes
Title
Self-Efficacy
Description
Inflammatory Bowel Disease Self-Efficacy Scale
Time Frame
Compare at baseline, 6-month and 12-month for any changes
Title
Inflammatory Bowel Disease- Related Quality of Life
Description
Short Quality of Life in Inflammatory Bowel Disease Questionnaire- SIBDQ
Time Frame
Compare at baseline, 6-month and 12-month for any changes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Meyers, MS Ed
Phone
412-454-4023
Email
meyersj5@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Szigethy, MD, PhD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Szigethy, MD, PhD
Phone
412-802-6696
Email
szigethye@upmc.edu
First Name & Middle Initial & Last Name & Degree
Eva Szigethy, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be shared. Data is shared at the aggregate level

Learn more about this trial

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

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