Clinical trial NCT06397729: Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
Official title: Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Obesity
Keywords: Digital health
Behavior Change
Physical Activity
Diet
Cardiovascular Disease
Obesity
Rural health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Missouri Highlands Health Care
First posted: 2024-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 behavior counseling and the patient experience that will improve patients' motivation to change, and their CVH health behaviors and outcomes.

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 elevated body mass index. Counseling is most effective when developed with and tailored to the patient and offered with resources that support healthy food intake and physical activity. Healthcare teams are challenged by the lack of accessible evidence-based, tailored recommendations and limited awareness of patient health behaviors and community resources, all of which are compounded by lack of time within the clinical workflow. Yet, digital health tools that can facilitate quality counseling and follow-up are not readily available for primary care teams - particularly those in low-resourced rural settings. The investigators will leverage our existing digital health tool (PREVENT) for healthcare teams, including Community Health Workers (CHWs), to use at the point-of-care with rural low-income patients who are overweight or obese and often have more severe social needs. PREVENT visually displays patient-reported and electronic health record data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. The investigators have been working with the Missouri Highlands Health Care, a federally-qualified health center with 10 clinics across 7 rural counties that has an existing CHW network, to adapt our tool to meet the needs of their health care teams and patients. This project will examine the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT among patients with overweight/obesity (N=100) using a clinic-randomized design in four clinics. The investigators believe that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients' motivation to change, CVH health behaviors, and outcomes. The investigators will seek to understand factors impacting implementation and sustainment of this approach to streamline the translation of this tool into routine care. Our ultimate goal is to improve CVH with enhanced health behavior counseling and follow-up using a multi-level approach that targets health behaviors and unmet social needs to give everyone an equal opportunity for health.

Eligibility criteria: Patient Inclusion Criteria:

* 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.

Primary outcomes:
measure: Healthcare team member confidence
timeFrame: baseline, at study completion (3 years)
measure: Quality counseling
timeFrame: Within 48 hours of clinic visit
Secondary outcomes:
measure: Provider satisfaction
timeFrame: at study completion (3 years)
measure: Shared Decision Making
timeFrame: 3 months into study
measure: Resource Offering
timeFrame: 6-months
measure: Patient satisfaction
timeFrame: Within 48 hours of clinic visit
measure: Patient motivation to change
timeFrame: at baseline, and 6-months
measure: Change in patients knowledge of CVH
timeFrame: at baseline, and 6-months
measure: Change in food intake behaviors
timeFrame: at baseline, and 6-months
measure: Change in physical activity behaviors
timeFrame: at baseline, and 6-months
measure: Change in body mass index (BMI) index z-score
timeFrame: At baseline, and 6-months
measure: Change on patient's average systolic and diastolic blood pressure
timeFrame: At baseline, and 6-months
measure: Change in patient's cholesterol at baseline and at study completion
timeFrame: At baseline, and 6-months
measure: Change in patient's blood glucose at baseline and at study completion
timeFrame: At baseline, and 6-months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Maura Kepper, PhD
role: PRINCIPAL_INVESTIGATOR
References: