RecruitingRecruiting
Penn Medicine Healthy Heart
NCT06062394 · University of Pennsylvania
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients on PCSK9 inhibitors
* Documented statin allergy/ or intolerance in the EMR
* Pregnancy
* Breast feeding
* Markedly shortened life expectancy including:
1. metastatic cancer
2. hospice
3. End Stage Renal Disease
4. Congestive Heart Failure
5. Dementia
* Is a non-English speaker requiring a translator
* Patients who do not have a cell phone
Study design
Enrollment target: 1980 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-03-11
Estimated completion: 2026-12
Last updated: 2026-03-12
Interventions
Behavioral: Penn Med Healthy Heart Program
Primary outcomes
- • Difference in mean Systolic Blood Pressure (SBP) (6-month period)
- • Difference in mean LDL-c (6-month period)
Sponsor
University of Pennsylvania · other
Contacts & investigators
ContactKayla Clark, MPH · contact · kayla.clark@pennmedicine.upenn.edu · 215-746-4428
ContactLaurie Norton, MA, MBE · contact · Laurie.Norton@pennmedicine.upenn.edu
InvestigatorKevin Volpp, MD, PhD · principal_investigator, University of Pennsylvania
All locations (1)
Penn MedicineRecruiting
Philadelphia, Pennsylvania, United States