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

NCT03985800 | Completed Results DMC

• 2 other identifiers: STUDY19020176IHS-2017C3-8930
• Study Type: interventional
• Target: 657
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Behavioral Symptoms

Outcome Measures

Primary Outcomes (2)

• IBD Symptom Severity

  IBD symptom severity was measured via a composite IBD Complexity Score developed by clinical researchers to quantify both biological and psychosocial domains of IBD within an SMH setting. It includes the sum of patient-reported responses to two scales: the PROMIS GI symptoms scale, evaluating four domains of gastrointestinal symptoms; and disease-specific PRO-2 disease severity indices taken from the Harvey Bradshaw Index (for individuals with Crohn's disease) and Ulcerative Colitis Activity Index (for individuals with ulcerative colitis). The complexity score is calculated by adding the value of the patient's PRO-2 to the cumulative PROMIS-GI score. Lower scores indicate lower symptom severity; higher scores indicate higher symptom severity. The minimum score is 0; the maximum score is open-ended based on patient response. Only the total IBD Complexity Score is reported.

  Compare scores at Baseline, 6-month and 12-month for any changes

• Behavioral Health Symptom Severity

  Behavioral health symptom severity was measured utilizing the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - which combines the PHQ-8 and GAD-7 scales - as a composite measure of depression and anxiety. The Patient Health Questionnaire 8-item depression scale (PHQ-8) and 7-item Generalized Anxiety Disorder scale (GAD-7) are among the best validated and most commonly used depression and anxiety measures, respectively. The PHQ-ADS is the sum of the PHQ-8 and GAD-7, where a decrease in scores indicates a decrease in BH symptom severity; a decrease of 3-4 points indicates MCID. Lower scores indicate lower levels of behavioral health symptom severity; higher scores indicate higher symptom severity. The minimum score is 0; the maximum score is 45. Only the total PHQ-ADS is reported.

  Compare at Baseline, 6-month and 12-month for any changes

Secondary Outcomes (5)

• Functional Impairment

  Compare at baseline, 6-month and 12-month for any changes

• IBD-IBS Symptom Severity

  Compare at baseline, 6-month and 12-month for any changes

• Health Care Utilization

  Compare at baseline, 6-month and 12-months for any changes

• Patient Engagement

  Compare at baseline, 6-month and 12-month for any changes

• Quality of Life

  Compare at baseline, 6-month and 12-month for any changes

Study Arms (2)

TEAM-care as usual approach

ACTIVE COMPARATOR

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. Minor modifications were made to the TEAM approach during the COVID-19 public health emergency to account for reduced face-to-face time without changing the underlying differentiation between the two models of delivering SMH care.

Other: TEAM

TECH-telehealth approach

ACTIVE COMPARATOR

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

Interventions

TEAM OTHER

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.

TEAM-care as usual approach

TECH OTHER

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.

TECH-telehealth approach

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Mount Sinai Hospital, New York: collaborator
• The Cleveland Clinic: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Limitations and Caveats

Sensitivity analyses confirmed that the COVID-19 pandemic did not have a significant impact on outcomes. Heterogeneity of patient and clinical factors could have introduced confounders that were not the focus of our primary analyses (e.g. specific comorbid medical diagnoses, the contribution of pharmacological treatment). Adherence/dose-effect was not examined beyond exploratory per-protocol analyses. Longer-term follow-up may have been needed to show impact on healthcare utilization.

Results Point of Contact

• Title: Eva Szigethy, Co-Principal Investigator, Adjunct Professor of Psychiatry, Staff Psychiatrist
• Organization: Department of Psychiatry, University of Pittsburgh

szigethye@upmc.edu

412-667-0416

Study Officials

• Eva Szigethy, MD, PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Medicine

Model Details: Comparison between technology interventions and in-person interventions.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 14, 2019
• Study Start: July 1, 2019
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)