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

Not Applicable

Completed

Conditions: Inflammatory Bowel Disease
Behavioral Symptoms

Registration Number: NCT03985800

Lead Sponsor: 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.

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.

Primary outcomes are composite scores of measures focused on 1) IBD Symptom Severity, and 2) BH Symptom Severity. IBD Symptom Severity is measured via a composite IBD Complexity Score involving responses to two patient-reported scales: the PROMIS-GI measure and either the Harvey Bradshaw Index (for participants with Crohn's disease) or ulcerative colitis activity index (for participants with ulcerative colitis). BH Symptom Severity was measured utilizing the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS), a composite of two patient-reported scale for measuring anxiety (Generalized Anxiety Disorder scale (GAD-7) and depression (Patient Health Questionnaire depression scale (PHQ-8). Scales are further defined in Results, Outcome Measures.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 657

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IBD Symptom Severity	Compare scores at Baseline, 6-month and 12-month for any changes	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.
Behavioral Health Symptom Severity	Compare at Baseline, 6-month and 12-month for any changes	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.

Secondary Outcome Measures

Name	Time	Method
Functional Impairment	Compare at baseline, 6-month and 12-month for any changes	Functional impairment was measured using the validated Short Form 12 Health Survey Version 2 (SF-12v2) which includes 12 items from the Short-Form 36 Health Survey and yields a physical and mental composite score as well as 8 subscale values: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Responses are tallied via a norm-based scoring algorithm provided by the assessment licensing company. Lower scores correspond with poorer health-related functioning; higher scores indicate better health-related functioning. The minimum score is 18.5; the maximum score is 142.6. Only the total composite score (the sum of both the physical and mental scales) is reported.
IBD-IBS Symptom Severity	Compare at baseline, 6-month and 12-month for any changes	IBD-IBS Symptom Severity was measured using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) to more accurately capture IBD symptom severity for many individuals with IBD, particularly those with inactive IBD but persistent functional GI symptoms (e.g., IBD-IBS). The IBS-SSS scores pain severity, pain frequency, abdominal bloating, bowel satisfaction and interference with life on a 0-100 scale with a total score of 500. A 50-point or more reduction in this score is considered clinically meaningful. Total scores range from 0 to 500 with higher scores indicating more severe symptoms. Answers to all questions are summed to achieve the total score. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) IBS. Only total scores are reported.
Health Care Utilization	Compare at baseline, 6-month and 12-months for any changes	Health care utilization was captured through EHR data to measure categorical (yes or no) instances of ED visits and inpatient hospitalizations at both 6- and 12-months post-enrollment.
Patient Engagement	Compare at baseline, 6-month and 12-month for any changes	Patient engagement was measured using the validated IBD Self-Efficacy Scale (IBD-SES) which assesses one's confidence level in managing stress and emotions, managing medical care, managing symptoms and disease, and maintaining remission. The IBD-SES measures self-management activities across four subscales (Stress and Emotions; Medical Care; Symptoms and Disease; Remission), with higher scores indicating greater confidence in self-management. Responses for each question are summed to produce one overall and four subscale scores. The total score range is between 29 and 290, with 29 indicating the lowest level of self-efficacy and 290 indicating the highest. Each item is scored 1-10, with 1 being assigned for responses of "Not confident at all" and a score of 10 assigned for responses of "Totally confident." Only total scores are reported.
Quality of Life	Compare at baseline, 6-month and 12-month for any changes	Quality of life was evaluated using the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated tool which measures physical, social, and emotional health-related quality of life (QOL) for patients with Crohn's disease and ulcerative colitis. On a 7-point scale, lower scores correspond with a lower perceived QOL, while higher scores represent a higher perceived QOL. Responses for each question are summed for a total score between 10 and 70, with 10 reflecting poor QOL and 70 reflecting high QOL. Each item is scored 1-7, with 1 being assigned for responses indicating the highest severity of symptoms, and 7 being assigned for those reflecting the lowest severity of symptoms. Only total scores are reported.

Trial Locations

Locations (1): University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States