Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics

Study Overview
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Brief Summary
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The focus on this application is low-income, rural patients, since cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents. Health behavior counseling and follow-up care are required for patients with an elevated body mass index who have increased risk for CVD. Counseling is most effective when developed with, and tailored to, the patient and offered with resources that support healthy food intake and physical activity. Resource referral and follow-up is particularly important in rural low income residents who often have more severe social needs that impede healthy behaviors. The proposed research will leverage the candidate's digital health tool (PREVENT) for healthcare teams to use within the clinic visit. PREVENT visually displays patient-reported and electronic health record (EHR) data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. PREVENT may improve the quality of required care and promote cardiovascular health equity. This research will: 1) collaborate with rural and clinic partners to modify and integrate the PREVENT tool for low-income, rural patients with obesity (Aim 1); and 2) conduct a pilot pragmatic clinical trial of PREVENT to optimize feasibility, acceptability, appropriateness, and potential health equity impact.

Official Title
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Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics

Conditions
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Obesity, Cardiovascular Diseases

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-64 years at baseline low-income (household income <200% poverty) a BMI ≥ 30 Receiving care from the Missouri Highlands. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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
Interventional Model Description: Clinic randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wait-List Control<br>Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following their clinic visit and at 6-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: PREVENT Intervention<br>Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 6-months after the clinic visit electronically and by mail At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk. A community health worker (CHW) will deliver a tailored behavioral change plan inclusive of patient-centered community resources. The CHW will provide ongoing support with goals and social needs for 6-months. | Behavioral: PREVENT<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>|

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. | 6-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. | Up to 12 weeks post-study | 
| 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. | 0-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in provider confidence: survey | Provider confidence in discussing CVH and health behaviors with overweight and obese patients will be assessed using a survey (4-questions). Questions are asked on 5-point Likert scale (range: 4-20) with a higher score indicating greater confidence. | At baseline, and 6-months | 
| Quality of health behavior counseling | Patient perceptions of the clinical interaction in which CVH and health behaviors will be assessed using a survey (10- questions). Questions are asked as yes/no/I don't' know. Quality counseling will be defined as patient reported yes to their care team: 1) talking to them about healthy food intake; 2) talking to them about physical activity 3) delivering goals and 4) delivering resources. | Immediately following clinic visit | 
| 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 5-point Likert scale (range: 15-75) with a higher score indicating greater motivation. | At baseline, and 6-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 6-months | 
| Change in minutes of moderate to vigorous physical activity | 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 6-months | 
| Change in body mass index (BMI) | Collected from patient's medical record. | At baseline, and 6-months | 
| Change on patient's average systolic and diastolic blood pressure | Collected from patient's medical record. | At baseline, and 6-months | 
| Change in patient's cholesterol | Collected from patient's medical record. | At baseline, and 6-months | 
| Change in patient's blood glucose | Collected from patient's medical record. | At baseline, and 6-months |