An interventional study of TEAM and TECH in Inflammatory Bowel Disease and Behavioral Symptoms, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other
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.
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.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's enrollment of 657 is above the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: Compare at Baseline, 6-month and 12-month for any changes
Functional Impairment
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.
Time frame: Compare at baseline, 6-month and 12-month for any changes
IBD-IBS Symptom Severity
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.
Time frame: Compare at baseline, 6-month and 12-month for any changes
Health Care Utilization
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.
Time frame: Compare at baseline, 6-month and 12-months for any changes
Patient Engagement
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.
Time frame: Compare at baseline, 6-month and 12-month for any changes
Quality of Life
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.
Time frame: Compare at baseline, 6-month and 12-month for any changes
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.
| Milestone | TEAM | TECH |
|---|---|---|
| Started | 329 | 328 |
| Completed | 323 | 320 |
| Not completed | 6 | 8 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Withdrawal by subject | 3 | 6 |
| Withdrew: Protocol violation | 2 | 0 |
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.
| Score on a scale | TEAM | TECH |
|---|---|---|
| Score at baseline | 75.9 ± 31.0 | 79.9 ± 31.3 |
| Score at 6-month follow-up | 63.5 ± 30.0 | 65.0 ± 33.2 |
| Score at 12-month follow-up | 62.3 ± 31.2 | 64.4 ± 32.2 |
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.
| Score on a scale | TEAM | TECH |
|---|---|---|
| Score at baseline | 25.4 ± 7.88 | 26.2 ± 7.94 |
| Score at 6-month follow-up | 18.7 ± 10.9 | 19.7 ± 10.9 |
| Score at 12-month follow-up | 18.0 ± 11.2 | 19.2 ± 11.5 |
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.
| Score on a scale | TEAM | TECH |
|---|---|---|
| Score at baseline | 37.6 ± 6.57 | 38.4 ± 6.36 |
| Score at 6-month follow-up | 34.2 ± 7.98 | 34.7 ± 7.58 |
| Score at 12-month follow-up | 33.3 ± 7.70 | 33.5 ± 8.07 |
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.
| Score on a scale | TEAM | TECH |
|---|---|---|
| Score at baseline | 222 ± 135 | 238 ± 130 |
| Score at 6-month follow-up | 185 ± 125 | 175 ± 123 |
| Score at 12-month follow-up | 174 ± 124 | 179 ± 125 |
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.
| Participants | TEAM | TECH |
|---|---|---|
| Hospitalizations — Yes | 35 | 36 |
| Hospitalizations — No | 292 | 291 |
| Hospitalizations — Missing | 2 | 1 |
| ED Visits — Yes | 27 | 31 |
| ED Visits — No | 297 | 297 |
| ED Visits — Missing | 5 | 0 |
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.
| Score on a scale | TEAM | TECH |
|---|---|---|
| Score at baseline | 161 ± 40 | 157 ± 35.8 |
| Score at 6-month follow-up | 174 ± 47.5 | 178 ± 46.9 |
| Score at 12-month follow-up | 178 ± 54.0 | 178 ± 49.7 |
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.
| Score on a scale | TEAM | TECH |
|---|---|---|
| Score at baseline | 37.7 ± 10.7 | 35.5 ± 10.7 |
| Score at 6-month follow-up | 42.6 ± 12.0 | 41.4 ± 11.9 |
| Score at 12-month follow-up | 43.0 ± 12.5 | 43.4 ± 12.4 |
Collected over From enrollment until end of follow-up (12 months after enrollment). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TEAM | 1/329 (0.3%) | 0/329 (0%) | 0/329 (0%) |
| TECH | 2/328 (0.6%) | 0/328 (0%) | 0/328 (0%) |
All enrolled participants were included in baseline analysis.
| Sex/Gender, Customized(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Gender — Female | 211 | 213 | 424 |
| Gender — Male | 93 | 90 | 183 |
| Gender — Other | 2 | 1 | 3 |
| Gender — Prefer not to answer | 1 | 1 | 2 |
| Gender — Missing | 22 | 23 | 45 |
| Ethnicity (NIH/OMB)(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 13 | 30 |
| Not Hispanic or Latino | 269 | 275 | 544 |
| Unknown or Not Reported | 43 | 40 | 83 |
| Race (NIH/OMB)(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 3 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 24 | 13 | 37 |
| White | 254 | 271 | 525 |
| More than one race | 5 | 11 | 16 |
| Unknown or Not Reported | 40 | 30 | 70 |
| IBD Diagnosis(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Crohn's disease | 222 | 218 | 440 |
| Ulcerative colitis | 107 | 110 | 217 |
| Steroid Use(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Yes | 121 | 119 | 240 |
| No | 208 | 209 | 417 |
| Opioid use(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Yes | 108 | 105 | 213 |
| No | 216 | 218 | 434 |
| Missing | 5 | 5 | 10 |
| Advanced therapy(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Yes | 185 | 169 | 354 |
| No | 144 | 159 | 303 |
| Comorbidity(Participants) | TEAM | TECH | Total |
|---|---|---|---|
| Yes | 147 | 143 | 290 |
| No | 182 | 185 | 367 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual Participant Data will not be shared. Data is shared at the aggregate level
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