Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
- Conditions
- Interventions
- Registration Number
- NCT06397729
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
This project will conduct a pilot hybrid study that examines the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT, a digital health intervention, among patients with overweight/obesity (N=100) using a clinic-randomized design. The central hypothesis of the study is that PREVENT will be feasible and show improvements in health beh...
- Detailed Description
Cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents in the United States. Maintaining healthy weight, physical activity, and food intake behaviors promotes cardiovascular health (CVH) and prevents CVD. The Health Resources and Services Administration requires health behavior counseling and follow-up care for patients with e...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Aged 18-64 years at baseline
- Low income (household income <200% FPL)
- At risk for poor CVH (body mass index greater than or equal to 30)
- Receiving care from the Missouri Highlands Healthcare
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Provider Inclusion Criteria:
• All providers and clinic staff (physicians, nurses, community health workers, clinic staff, clinic research associates) in the Missouri Highlands Healthcare Clinics are eligible to participate.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients - Wait-List Control Wait-List Control * Complete questionnaires at baseline, within 48 hours of their routine clinic visit, and 6-months after the clinic visit. All surveys will be administered electronically or 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. Patients- PREVENT Tool PREVENT Tool * Complete questionnaires at baseline, within 48 hours of their routine clinic visit, and 6-months after the clinic visit. All surveys will be administered electronically or 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. Community Health Workers will follow up with patients monthly to support behavior change.
- Primary Outcome Measures
Name Time Method Healthcare team member confidence baseline, at study completion (3 years) A survey (4-questions) will assess provider's confidence in delivering health behavior counseling and discussing cardiovascular health with patients. Questions are asked on a 5-point Likert scale (range: 4-20) with a higher score indicating greater satisfaction. Change in confidence from baseline to post-study will be compared in intervention clinics versus ...
Quality counseling Within 48 hours of clinic visit A 12 question survey will ask patients 1) if they have been counseled on 10 topics Life's Essential 8 (obesity, blood pressure, physical activity, food intake, smoking, sleep, cholesterol, and diabetes), and two distractor topics (flu vaccination and seat belt use); 2) if they received goals for healthy eating and/or physical activity; and 3) if they receive...
- Secondary Outcome Measures
Name Time Method Provider satisfaction at study completion (3 years) A survey (33-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology (content, accuracy, format, ease of use and timeliness) and PREVENT's fit with their clinic workflow. Questions are asked on a 5-point Likert scale (range: 33-165) with a higher score indicating greater satisfaction.
Shared Decision Making 3 months into study Direct observation of intervention visits will be conducted using the Observing Patient Involvement in Decision Making instrument62 to understand the extent to which the PREVENT tool facilitates shared decision making.
Change in food intake behaviors at baseline, and 6-months Patients report servings per week or per day for fruit intake, vegetable intake, whole grains, sugar-sweetened beverages, fast food consumption, and snacking behaviors.
Change in patient's cholesterol at baseline and at study completion At baseline, and 6-months Collected from patient's medical record
Resource Offering 6-months The number and type of resources offered will be tracked by PREVENT for each patient
Patient motivation to change at baseline, and 6-months A survey (11-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 5-point Likert scale (range: 11-55) with a higher score indicating greater motivation.
Change on patient's average systolic and diastolic blood pressure At baseline, and 6-months Collected from patient's medical record
Patient satisfaction Within 48 hours of clinic visit 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.
Change in patients knowledge of CVH at baseline, and 6-months A survey (4-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 5-point Likert scale (range: 4-20) with a higher score indicating greater knowledge.
Change in physical activity behaviors at baseline, and 6-months 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.
Change in body mass index (BMI) index z-score At baseline, and 6-months Collected from patient's medical record.
Change in patient's blood glucose at baseline and at study completion At baseline, and 6-months Collected from patient's medical record
Trial Locations
- Locations (1)
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States