Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,980
- 试验地点
- 1
- 主要终点
- Difference in mean Systolic Blood Pressure (SBP)
研究概览
简要总结
To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll a program that will be evaluated in a clinical trial that is focused on changing patient behavior and powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest Philadelphia and Lancaster.
详细描述
To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll Penn Medicine primary care patients into the Penn Medicine Healthy Heart, a six-month program for reduction of hypertension and hypercholesterolemia grounded in behavioral economics insights to increase uptake of and adherence to evidence-based interventions to reduce ASCVD risk. Penn Medicine Healthy Heart emphasizes proactive outreach and prevention outside of a traditional visit model using data assets to identify and risk stratify patients. The program aims to relieve overburdened PCPs through automated hovering technology coupled with a centralized, leveraged team of non-clinical navigators and nurse practitioners. The clinical trial will assess Penn Medicine Healthy Heart and will be powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest/Downtown Philadelphia and Lancaster, PA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On the Penn Medicine Primary Care Service Line registry
- •Last 2 Blood Pressure readings with Systolic Blood Pressure >=140 from any outpatient encounter in the last 12 months AND
- •ASCVD dx OR ASCVD risk score ≥10% OR Diabetes dx OR A1c ≥6.5 in last year OR Diabetes registry OR Last LDL ≥190 in past five years AND
- •Not on a statinor PCSK9, Inclisiran OR on a Low-intensity/moderate-intensity statin) with LDL >100
排除标准
- •Patients on PCSK9 inhibitors
- •Documented statin allergy/ or intolerance in the EMR
- •Pregnancy
- •Breast feeding
- •Markedly shortened life expectancy including:
- •metastatic cancer
- •End Stage Renal Disease
- •Congestive Heart Failure
- •Is a non-English speaker requiring a translator
- •Patients who do not have a cell phone
研究组 & 干预措施
Usual Care
This group will not receive the intervention and will continue with usual care.
Penn Med Healthy Heart Program
The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
干预措施: Penn Med Healthy Heart Program (Behavioral)
结局指标
主要结局
Difference in mean Systolic Blood Pressure (SBP)
时间窗: 6-month period
Whether mean SBP is improved among those assigned to intervention vs those assigned to control
Difference in mean LDL-c
时间窗: 6-month period
Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control
次要结局
- Engagement in the BP intervention(6-month period)
- Difference in Diastolic Blood Pressure (DBP)(6-month period)