Key result
Penn Medicine trial tests centralized remote care to improve blood pressure and LDL-C in high-risk patients.
Why the study?
Suboptimal control of hypertension and hyperlipidemia contributes to ASCVD risk, and effectiveness of a centralized approach to improve risk factor management is being tested.
Does a centrally organized care approach using remote monitoring, text messaging, and clinical navigators improve systolic blood pressure and LDL-C in primary care patients at elevated ASCVD risk?
RCT (n=2,420)
Single-blind (blinding for the analytic team and investigators but not participants or clinical team)
1:1 ratio, stratified by geographic clusters
Yes
Does a centrally organized care approach using remote monitoring, text messaging, and clinical navigators improve systolic blood pressure and LDL-C in primary care patients at elevated ASCVD risk?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“PMHH extends care outside of traditional office-based visits to increase patient access in lowering their risk of heart attacks and strokes by improving their blood pressure and cholesterol. This means that patient needs can be more frequently addressed between office visits rather than wait weeks or months until the next appointment to make changes in blood pressure and cholesterol management. Combining hovering with a centralized team working in collaboration with PCPs helps to improve patients' cardiovascular health and create a supportive experience for patients.”
“Prior to the ready availability of electronic medical records and text-capable cell phones, interventions to reduce atherosclerotic cardiovascular disease (ASCVD) risk relied on patient office visits or hospital-based care. The greater availability of remote patient monitoring and telemedicine in the last few years has created opportunities for reaching outside the traditional models of health care delivery to bring more timely, convenient, and high-quality care to patients. This program leverages new technologies for proactive outreach and health management to a large population of patients.”
This design and rationale paper outlines a pragmatic, randomized trial evaluating whether a centralized team approach using remote monitoring and behavioral strategies can improve blood pressure and cholesterol control in high-risk ASCVD patients compared to usual primary care.
Rationales: Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Suboptimal control of hypertension and hyperlipidemia are common factors contributing to ASCVD risk. The Penn Medicine Healthy Heart (PMHH) Study is a randomized clinical trial testing the effectiveness of a system designed to offload work from primary care clinicians and improve patient follow-through with risk reduction strategies by using a centralized team of non-clinical navigators and advanced practice providers, remote monitoring, and bi-directional text messaging, augmented by behavioral science engagement strategies. The intervention builds on prior non-randomized evaluations of these design elements that demonstrated significant improvement in patients’ systolic blood pressure and LDL Cholesterol (LDL-C). Primary hypothesis: Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention. Design: Randomized clinical trial of Penn Medicine Healthy Heart in patients aged 35-80 years at elevated risk of ASCVD whose systolic blood pressure and LDL-C are not well controlled. The intervention consists of four modules that address blood pressure management, lipid management, nutrition, and smoking cessation, offered in a phased approach to give the participant time to learn about each topic, adopt any recommendations, and build a relationship with the care team. Sites: University of Pennsylvania Health System at primary care practices located in inner-city urban and rural/semi-rural areas Primary Outcomes: Improvement in systolic blood pressure and LDL-C Secondary Outcomes: Cost-effectiveness analyses are planned to evaluate the health care costs and health outcomes of the intervention approach. An implementation evaluation is planned to understand factors influencing success of the intervention. Estimated enrollment: 2,420 active patients of Penn Medicine primary care practices who have clinical ASCVD, or who are at elevated risk for ASCVD, and who are (a) not on statins or have LDL-C > 100 despite being on statins and (b) had systolic blood pressure>140 at two recent ambulatory visits. Enrollment dates: March 2024-March 2025. The intervention will last 6 months with a 12-month follow-up to determine whether its effects persist. Current status: Enrolling (1,240 enrolled as of August 15, 2024)
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Volpp et al. (2024) conducted an RCT in Elevated risk of ASCVD with suboptimal blood pressure and LDL-C control (n=2,420). Centralized remote monitoring and navigator team program (Penn Medicine Healthy Heart) vs. Usual care was evaluated on Systolic blood pressure and LDL-C at 6 months. The Penn Medicine Healthy Heart study is an ongoing randomized clinical trial designed to evaluate whether a centralized remote care model improves blood pressure and LDL cholesterol in high-risk patients.
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