Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

Study Overview
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Brief Summary
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Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.

Official Title
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Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

Conditions
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Cardiovascular Diseases, Obesity

Intervention / Treatment
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* Behavioral: PREVENT tool
* Behavioral: Wait-list Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 12-17 years at baseline at risk for poor CVH (body mass index >= 85th percentile) Receiving care from the Healthy Start Clinic at Barnes Jewish Hospital.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients - Wait-List Control<br>Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered at 3-months after the clinic visit electronically and by mail. • A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement. | Behavioral: Wait-list Control<br>* Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool<br>|
| Experimental: Experimental: Patients - PREVENT Tool<br>Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 3-months after the clinic visit electronically and by mail • At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. | Behavioral: PREVENT tool<br>* PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.<br>|
| No Intervention: Providers<br>-All eligible providers will be sent questionnaires electronically to their email at baseline, following provider training and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction of PREVENT tool: survey | A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction. | 3-months | 
| Provider's satisfaction of PREVENT tool: survey | A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction. | 3-months | 
| Fidelity of PREVENT tool implementation | Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended. | 0-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's motivation | A survey (15-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 4-point Likert scale (range: 15-60) with a higher score indicating greater motivation. | At baseline, and 3-months | 
| Change in patient's knowledge of CVH | A survey (3-question) administered to patients to assess their knowledge of CVH risk (perceived value/importance of healthy behaviors) and awareness of resources. Questions are asked using a 4-point Likert scale (range: 3-12) with a higher score indicating greater knowledge. | At baseline, and 3-months | 
| Change in food intake behaviors | Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey. | At baseline, and 3-months | 
| Change in physical activity behaviors | Patient-reported physical activity (minutes of moderate and vigorous activity per week) are collected using a survey (4-questions). Patients report the average number of minutes of moderate and vigorous activity they do per week. | At baseline, and 3-months | 
| Change in body mass index z-score | Collected from patient's medical record. BMI z-score was calculated using the Centers for Disease Control and Prevention Growth Charts. The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group. | At baseline, and 3-months | 
| Change on patient's average systolic and diastolic blood pressure | Collected from patient's medical record | At baseline, and 3-months | 
| Change in patient's cholesterol | Collected from patient's medical record | At baseline, and 3-months | 
| Change in patient's blood glucose | Collected from patient's medical record | At baseline, and 3-months |