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| ID | Type | Description | Link |
|---|---|---|---|
| IHS-2017C3-8930 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Mount Sinai Hospital, New York | OTHER |
| The Cleveland Clinic | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Szigethy, MD, PhD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
Individual Participant Data will not be shared. Data is shared at the aggregate level
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants were included in baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex/Gender, Customized | Sex/gender self-reported by participants at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Compare scores at Baseline, 6-month and 12-month for any changes |
From enrollment until end of follow-up (12 months after enrollment)
All enrolled participants were included in the analysis population for adverse events. Adverse events align with ClinicalTrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Szigethy, Co-Principal Investigator, Adjunct Professor of Psychiatry, Staff Psychiatrist | Department of Psychiatry, University of Pittsburgh | 412-667-0416 | szigethye@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2025 | Aug 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Comparison between technology interventions and in-person interventions.
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| 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. |
|
| 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. | 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. | 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. | 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. | Compare at baseline, 6-month and 12-month for any changes |
| Protocol Violation |
|
| BG001 |
| TECH |
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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity self-reported by participants at baseline. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race self-reported by participants at baseline. | Count of Participants | Participants |
|
| IBD Diagnosis | IBD diagnosis confirmed by physician at baseline. | Count of Participants | Participants |
|
| Steroid Use | Incidence of steroid prescription at baseline was extracted from the electronic medical record. | Count of Participants | Participants |
|
| Opioid use | Incidence of opioid prescription at baseline was extracted from the electronic medical record. | Count of Participants | Participants |
|
| Advanced therapy | Incidence of advanced IBD therapy prescription at baseline was extracted from the electronic medical record. Advanced therapies include: Infliximab/Remicade, Adalimumab/Humira, Certolizumab/Cimzia, Golimumab/Simponi, Vedolizumab/Entyvio, Natalizumab/Tysabri, Ustekinumab/Stelara, Tofacitinib/Xeljanz, and Ozanimod/Zyposia. | Count of Participants | Participants |
|
| Comorbidity | Incidence of any one of 14 investigator-defined select comorbidities at baseline. Comorbidities of interest include: AIDS; autonomic disorder; chronic kidney disease; chronic pain syndrome; connective tissue disease; COVID-19; diabetes (Type 1 or 2); irritable bowel syndrome; liver disease; peptic ulcer disease; primary sclerosing cholangitis; rheumatologic disease; short gut syndrome; and systemic autoimmune conditions. | Count of Participants | Participants |
|
| Age, Continuous | Age of participants at baseline. | Mean | Standard Deviation | Years |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | TECH | 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. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Compare at Baseline, 6-month and 12-month for any changes |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Compare at baseline, 6-month and 12-month for any changes |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Compare at baseline, 6-month and 12-month for any changes |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Compare at baseline, 6-month and 12-months for any changes |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Compare at baseline, 6-month and 12-month for any changes |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Compare at baseline, 6-month and 12-month for any changes |
|
|
|
|
| 1 |
| 329 |
| 0 |
| 329 |
| 0 |
| 329 |
| EG001 | TECH | 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. | 2 | 328 | 0 | 328 | 0 | 328 |
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| D001519 | Behavior |
| Score at 12-month follow-up |
|
| Aim 2a, moderation by disease activity. Null hypothesis: Disease activity does not moderate the trajectory of behavioral health score by treatment group. | Mixed Models Analysis | 0.55 | Threshold for statistical significance was 0.05. | Type III Wald chi-squared | 1.21 | Superiority | Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1*X+B2*M+B3*X*M+ε, where ε~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50. |
| Aim 2b, moderation by age. Null hypothesis: Age does not moderate the trajectory of behavioral health score by treatment group. | Mixed Models Analysis | The Chi-squared statistic for the group*time*age interaction term is 1.37 with two degrees of freedom. | 0.50 | Threshold for statistical significance was 0.05. | Type III Wald chi-squared | 1.37 | Superiority | Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1*X+B2*M+B3*X*M+ε, where ε~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50. |
| Aim 2b, moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of behavioral health score by treatment group. | Mixed Models Analysis | The Chi-squared statistic for the group*time*diagnosis interaction term is 5.16 with two degrees of freedom. | 0.08 | Threshold for statistical significance was 0.05. | Type III Wald chi-squared | 5.16 | Superiority | Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1*X+B2*M+B3*X*M+ε, where ε~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50. |
| Aim 2b, moderation by site. Null hypothesis: Site does not moderate the trajectory of behavioral health score by treatment group. | Mixed Models Analysis | The Chi-squared statistic for the group*time*site interaction term is 0.11 with two degrees of freedom. | 1.0 | Threshold for statistical significance was 0.05. | Type III Wald chi-squared | 0.11 | Superiority | Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1*X+B2*M+B3*X*M+ε, where ε~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50. |
| Aim 2b, moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of behavioral health score by treatment group. | Mixed Models Analysis | The Chi-squared statistic for the group*time*eHealth literacy interaction term is 3.23 with two degrees of freedom. | 0.20 | Threshold for statistical significance was 0.05 | Type III Wald chi-squared | 3.23 | Superiority | Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1*X+B2*M+B3*X*M+ε, where ε~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50. |
| Score at 12-month follow-up |
|
| Score at 12-month follow-up |
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| Missing |
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| ED Visits |
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| Null hypothesis: The trajectory of ED visits does not differ by treatment group. | Mixed Models Analysis | For ED visits, the Chi-squared statistic for the group*time interaction term is 0.82 with two degrees of freedom. | 0.67 | The threshold for statistical significance was .05. | Type III Wald chi-squared | 0.82 | Superiority | We calculated statistical power for the target sample size of 675 (~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1. |
| Score at 12-month follow-up |
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| Score at 12-month follow-up |
|