Penn Medicine Healthy Heart
- Conditions
- HypertensionHyperlipidemias
- Interventions
- Behavioral: Penn Med Healthy Heart Program
- Registration Number
- NCT06062394
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1980
- 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
-
Patients on PCSK9 inhibitors
-
Documented statin allergy/ or intolerance in the EMR
-
Pregnancy
-
Breast feeding
-
Markedly shortened life expectancy including:
- metastatic cancer
- hospice
- End Stage Renal Disease
- Congestive Heart Failure
- Dementia
-
Is a non-English speaker requiring a translator
-
Patients who do not have a cell phone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Penn Med Healthy Heart Program Penn Med Healthy Heart Program The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
- Primary Outcome Measures
Name Time Method Difference in mean Systolic Blood Pressure (SBP) 6-month period Whether mean SBP is improved among those assigned to intervention vs those assigned to control
Difference in mean LDL-c 6-month period Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control
- Secondary Outcome Measures
Name Time Method Engagement in the BP intervention 6-month period Engagement in the BP intervention as measured by number of participants who agree to receive blood pressure monitor
Difference in Diastolic Blood Pressure (DBP) 6-month period Whether mean DBP is improved among those assigned to intervention vs those assigned to control Whether mean SBP is improved among those assigned to intervention vs those assigned to control
Trial Locations
- Locations (1)
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States