Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-69
SponsorMedical College of Wisconsin

About this trial

Cardiometabolic diseases are major causes of morbidity and mortality in the state of Wisconsin and are expected to pose an increasing burden over the next few decades. A crucial initial step in preventing or delaying the onset of these diseases is to assess disease risk at the individual level. However, the accuracy of risk prediction of disease events based on conventional risk factors remains modest. Incorporating a polygenic risk score (PRS) into risk equations improves risk prediction but there is uncertainty about how best to integrate PRSs into primary care settings, given the lack of familiarity with PRSs among patients and providers. Probabilistic estimates for risks of cardiometabolic diseases may be misunderstood, and genetic risk assessment may not be trusted by those in low resource rural or inner-city settings. The potential for using PRSs to refine disease risk estimates has led to numerous studies to assess their clinical utility; however, the vast majority have been conducted in tertiary academic medical centers, raising concern that communities with diminished access to care could be left behind. The study team will investigate how the use of PRSs for such diseases influences health outcomes in rural and inner-city settings. The study team will leverage prior experience in conducting the MIGENES randomized clinical trial (RCT) of disclosing polygenic risk of CHD in a preventive cardiology setting of an academic center. In the proposed study, the investigators will conduct a pragmatic RCT to extend the investigation to 'real-world' settings of primary care clinics in a rural medical center and an urban Federally Qualified Health Center (FQHC). The investigators will engage a Community Advisory Board (CAB) through focus groups to gather feedback on implementing PRS-guided screening, related medical and lifestyle interventions, and public health strategies to reduce CHD risk. Feedback will inform provider education, targeted outreach to Wisconsin residents, and identification of barriers to adoption. The study team will also assess primary care physicians' and patients' familiarity with polygenic risk, their attitudes toward PRS testing, and intended actions based on results, comparing responses across rural and urban settings. The 10-yr risk of CHD will be estimated based on pooled cohort equations (PCE). Participants will view a video describing how cardiovascular risk was estimated and how lifestyle changes and drug therapy could reduce such risk and, in those randomized to receive PRS, the probabilistic nature of genetic risk. Patients will then see their PCP to review the 10-yr CHD risk estimate and engage in shared decision-making regarding statin therapy. Patient and clinician understanding of polygenic risk information will be assessed, as well as health-related and behavioral outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 40-69 years of age

No prior history of coronary heart disease

No prior use of statin medication

Has primary care provider

Disqualifiers

Prior history of coronary heart disease

current use of statin medication

Trial population

Adults who receive their primary care in Milwaukee and Shawano Counties in the state of Wisconsin.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Polygenic risk score

    Other intervention

    The polygenic risk score is a precision medicine screening tool to determine one's future risk of coronary heart disease.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Adults aged 40-69 years1 intervention

Trial outcomes

Primary outcomes

1

The number of patients initiated on a statin medication

Primary outcome will be whether a participant was prescribed a statin medication.

Time frame
Within 6 months of shared decision-making visit with primary care provider.

Secondary outcomes

1

A decrease in LDL cholesterol in patients who received the polygenic risk score

LDL cholesterol as measured by lipid panel

Time frame
Within 6 months of shared decision making
2

Number of patients with new diagnosis of coronary heart disease in patients who received the polygenic risk score

New diagnosis of coronary heart disease

Time frame
Within 6 months of shared decision making
3

A decrease in body weight in patients who received the polygenic risk score

Subject's total body weight

Time frame
Within 6 months of shared decision making
4

A change in blood pressure in patient who received the polygenic risk score

Blood pressure

Time frame
Within 6 months of shared decision making

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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