Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue (RESPOND) to Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- The number of patients initiated on a statin medication
研究概览
简要总结
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.
详细描述
Description of study design:
The study team will conduct a pragmatic randomized, controlled trial at two sites (rural versus urban). At each site the team will enroll 100 adults aged 40-69 years without known CHD and who are not on a statin. 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. DNA will be obtained from saliva/blood and a PRS for CHD will be calculated in a CLIA-certified laboratory, using the global diversity array. Patients will then see their PCP to review the 10-yr CHD risk estimate and engage in shared decision-making regarding statin therapy. The study team will assess patient and clinician understanding of polygenic risk information, as well as health-related and behavioral outcomes.
Visit #1: In individuals who have consented for the study, height, weight, and blood pressure will be measured by the study coordinator at the baseline study visit. Demographic information, medication history, and family history (details above) will be collected. A 5ml blood draw will be performed by a trained individual for both a lipid panel and for genotyping. Participant fills out surveys for baseline qualitative assessments. (e.g. numeracy, genetic literacy, perceived heart disease risk, perceived personal control, intention to change, anxiety, impact of events, genetic determinism of understanding PRS results, smoking status, dietary fat, physical activity level, concerns about placing PRS in the HER, intent to pursue medical assistance or counseling in response to PRS, views regarding sharing results with family members, worries about future employability or insurance coverage)
Visit #2: Participants will return after 2 months to be randomized to disclosure of risk estimate based on conventional risk score (CRS) versus an integrated risk score (IRS). The study coordinator will disclose the 10-yr coronary heart disease risk and walk the subject through a 10 minute educational video. This will be followed by a visit with the primary care physician/provider. The patient and provider will then engage in shared decision-making regarding statin initiation. Participant fills out surveys to assess post-disclosure qualitative assessments. (e.g. perceived heart disease risk, perceived personal control, intention to change, impact of events, genetic determinism understanding PRS results, smoking status, dietary fat, physical activity, communication of results, comprehension of results, shared decision-making satisfaction, knowledge transfer, decisional conflict, recall, decisional regret, concerns about placing PRS in the HER, intent to pursue medical assistance or counseling in response to PRS, views regarding sharing results with family members, worries about future employability or insurance coverage)
Physician outcomes. A post-visit questionnaire will assess physicians' satisfaction with the risk communication tool and the decision-making process. The study team will address any bias related to interpretation of PRS. The survey will be completed immediately following the patient visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 40-69 years of age
- •No prior history of coronary heart disease
- •No prior use of statin medication
- •Has primary care provider
排除标准
- •Prior history of coronary heart disease
- •current use of statin medication
研究组 & 干预措施
Adults aged 40-69 years
Adults aged 40-69 years without known coronary heart disease and who are not currently prescribed a statin medication.
干预措施: Polygenic risk score (Other)
结局指标
主要结局
The number of patients initiated on a statin medication
时间窗: Within 6 months of shared decision-making visit with primary care provider.
Primary outcome will be whether a participant was prescribed a statin medication.
次要结局
- A decrease in LDL cholesterol in patients who received the polygenic risk score(Within 6 months of shared decision making)
- A change in blood pressure in patient who received the polygenic risk score(Within 6 months of shared decision making)
- Lowered fasting glucose in patients who received the polygenic risk score(Within 6 months of shared decision making with primary care provider)
- Number of patients with new diagnosis of coronary heart disease in patients who received the polygenic risk score(Within 6 months of shared decision making)
- Number of patients that stop smoking who have received the polygenic risk score(Within 6 months of shared decision making with primary care provider)
- A decrease in body weight in patients who received the polygenic risk score(Within 6 months of shared decision making)
研究者
Julie K. Freed
Associate Professor
Medical College of Wisconsin