Trial Outcomes & Findings for Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions (NCT NCT03985800)
NCT ID: NCT03985800
Last Updated: 2025-09-03
Results Overview
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.
COMPLETED
NA
657 participants
Compare scores at Baseline, 6-month and 12-month for any changes
2025-09-03
Participant Flow
Recruitment began on July 1, 2019 and was completed on February 28, 2024. A brief pause in recruitment occurred between March 13 and September 13, 2020 to account for disruptions related to the COVID-19 pandemic. All participants were recruited from one of three specialty medical home clinics at large urban academic centers in the northeastern US: UPMC in Pittsburgh, Mount Sinai Hospital in New York, and the Cleveland Clinic in Cleveland.
All participants were randomly assigned to one of the two intervention arms upon successful enrollment in the study. Allocation was stratified based on age (18-30 or 31-60), IBD diagnosis (Crohn's disease or ulcerative colitis) and disease activity (low or high).
Participant milestones
| Measure |
TEAM
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
TECH is a low-human touch approach leveraging behavioral digital tools - primarily a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Overall Study
STARTED
|
329
|
328
|
|
Overall Study
COMPLETED
|
323
|
320
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
TEAM
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
TECH is a low-human touch approach leveraging behavioral digital tools - primarily a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Baseline characteristics by cohort
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
Total
n=657 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex/Gender, Customized
Gender · Female
|
211 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to answer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Missing
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
269 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
544 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
254 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
IBD Diagnosis
Crohn's disease
|
222 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
440 Participants
n=5 Participants
|
|
IBD Diagnosis
Ulcerative colitis
|
107 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Steroid Use
Yes
|
121 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Steroid Use
No
|
208 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Opioid use
Yes
|
108 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Opioid use
No
|
216 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
434 Participants
n=5 Participants
|
|
Opioid use
Missing
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Advanced therapy
Yes
|
185 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Advanced therapy
No
|
144 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Comorbidity
Yes
|
147 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Comorbidity
No
|
182 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Age, Continuous
|
34.7 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
34.9 Years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
34.8 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Compare scores at Baseline, 6-month and 12-month for any changesPopulation: Participants were included in the analysis for IBD Symptom Severity as long as they had complete covariate data and the IBD Complexity Score measured at at least one timepoint.
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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
IBD Symptom Severity
Score at baseline
|
75.9 Score on a scale
Standard Deviation 31.0
|
79.9 Score on a scale
Standard Deviation 31.3
|
|
IBD Symptom Severity
Score at 6-month follow-up
|
63.5 Score on a scale
Standard Deviation 30.0
|
65.0 Score on a scale
Standard Deviation 33.2
|
|
IBD Symptom Severity
Score at 12-month follow-up
|
62.3 Score on a scale
Standard Deviation 31.2
|
64.4 Score on a scale
Standard Deviation 32.2
|
PRIMARY outcome
Timeframe: Compare at Baseline, 6-month and 12-month for any changesBehavioral 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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Behavioral Health Symptom Severity
Score at baseline
|
25.4 Score on a scale
Standard Deviation 7.88
|
26.2 Score on a scale
Standard Deviation 7.94
|
|
Behavioral Health Symptom Severity
Score at 6-month follow-up
|
18.7 Score on a scale
Standard Deviation 10.9
|
19.7 Score on a scale
Standard Deviation 10.9
|
|
Behavioral Health Symptom Severity
Score at 12-month follow-up
|
18.0 Score on a scale
Standard Deviation 11.2
|
19.2 Score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Compare at baseline, 6-month and 12-month for any changesFunctional 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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Functional Impairment
Score at baseline
|
37.6 Score on a scale
Standard Deviation 6.57
|
38.4 Score on a scale
Standard Deviation 6.36
|
|
Functional Impairment
Score at 6-month follow-up
|
34.2 Score on a scale
Standard Deviation 7.98
|
34.7 Score on a scale
Standard Deviation 7.58
|
|
Functional Impairment
Score at 12-month follow-up
|
33.3 Score on a scale
Standard Deviation 7.70
|
33.5 Score on a scale
Standard Deviation 8.07
|
SECONDARY outcome
Timeframe: Compare at baseline, 6-month and 12-month for any changesIBD-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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
IBD-IBS Symptom Severity
Score at baseline
|
222 Score on a scale
Standard Deviation 135
|
238 Score on a scale
Standard Deviation 130
|
|
IBD-IBS Symptom Severity
Score at 6-month follow-up
|
185 Score on a scale
Standard Deviation 125
|
175 Score on a scale
Standard Deviation 123
|
|
IBD-IBS Symptom Severity
Score at 12-month follow-up
|
174 Score on a scale
Standard Deviation 124
|
179 Score on a scale
Standard Deviation 125
|
SECONDARY outcome
Timeframe: Compare at baseline, 6-month and 12-months for any changesHealth 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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Health Care Utilization
Hospitalizations · Yes
|
35 Participants
|
36 Participants
|
|
Health Care Utilization
Hospitalizations · No
|
292 Participants
|
291 Participants
|
|
Health Care Utilization
Hospitalizations · Missing
|
2 Participants
|
1 Participants
|
|
Health Care Utilization
ED Visits · Yes
|
27 Participants
|
31 Participants
|
|
Health Care Utilization
ED Visits · No
|
297 Participants
|
297 Participants
|
|
Health Care Utilization
ED Visits · Missing
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Compare at baseline, 6-month and 12-month for any changesPatient 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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Patient Engagement
Score at baseline
|
161 Score on a scale
Standard Deviation 40
|
157 Score on a scale
Standard Deviation 35.8
|
|
Patient Engagement
Score at 6-month follow-up
|
174 Score on a scale
Standard Deviation 47.5
|
178 Score on a scale
Standard Deviation 46.9
|
|
Patient Engagement
Score at 12-month follow-up
|
178 Score on a scale
Standard Deviation 54.0
|
178 Score on a scale
Standard Deviation 49.7
|
SECONDARY outcome
Timeframe: Compare at baseline, 6-month and 12-month for any changesQuality 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.
Outcome measures
| Measure |
TEAM
n=329 Participants
TEAM is a high-human touch, multidisciplinary specialty medical home approach that connects participants with a personalized care team including gastroenterologists, advanced practice providers, behavioral health specialists, dietitians, registered nurses, pharmacists, and health coordinators who provide intensive support and resources for patients.
|
TECH
n=328 Participants
TECH is a low-human touch approach leveraging behavioral digital tools - primarily RxWell, a digital cognitive behavioral therapy mobile application with embedded health coaches - to deliver behavioral health care at the patient's convenience.
|
|---|---|---|
|
Quality of Life
Score at baseline
|
37.7 Score on a scale
Standard Deviation 10.7
|
35.5 Score on a scale
Standard Deviation 10.7
|
|
Quality of Life
Score at 6-month follow-up
|
42.6 Score on a scale
Standard Deviation 12.0
|
41.4 Score on a scale
Standard Deviation 11.9
|
|
Quality of Life
Score at 12-month follow-up
|
43.0 Score on a scale
Standard Deviation 12.5
|
43.4 Score on a scale
Standard Deviation 12.4
|
Adverse Events
TEAM
TECH
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eva Szigethy, Co-Principal Investigator, Adjunct Professor of Psychiatry, Staff Psychiatrist
Department of Psychiatry, University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place