Penn Medicine Healthy Heart
Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
1 other identifier
interventional
1,980
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Mar 2024
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedStudy Start
First participant enrolled
March 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 12, 2026
March 1, 2026
2.7 years
September 25, 2023
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Difference in mean Systolic Blood Pressure (SBP)
Whether mean SBP is improved among those assigned to intervention vs those assigned to control
6-month period
Difference in mean LDL-c
Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control
6-month period
Secondary Outcomes (2)
Engagement in the BP intervention
6-month period
Difference in Diastolic Blood Pressure (DBP)
6-month period
Study Arms (2)
Usual Care
NO INTERVENTIONThis group will not receive the intervention and will continue with usual care.
Penn Med Healthy Heart Program
EXPERIMENTALThe Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
Interventions
Patients randomized to the intervention arm will be assigned a Patient Navigator (Clinical Research Coordinators, with support from Nurse Practitioners and a Medical Director) who will conduct an initial assessment with the patient to determine their main barriers to improving blood pressure and cholesterol control. The Patient Navigators will provide the patient with a home blood pressure cuff for remote monitoring, support from Way to Health text message reminders, referrals to established Penn Medicine smoking cessation programs, and referrals to nutrition and social workers as applicable. The Patient Navigators will help move the patients through four modules: Blood Pressure, Food Insecurity/Nutrition Screening, Statins, and Smoking Cessation. These modules provide patients with the chance to work on blood pressure, cholesterol control, access nutrition resources, and smoking cessation simultaneously or sequentially.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Volpp KG, Mahraj K, Norton LA, Asch DA, Glanz K, Mehta SJ, Balasta M, Kellum W, Wood J, Russell LB, Fanaroff AC, Bakshi S, Jacoby D, Cohen JB, Press MJ, Clark K, Zhu J, Rareside C, Ashcraft LE, Snider C, Putt ME. Design and rationale of penn medicine healthy heart, a randomized trial of effectiveness of a centrally organized approach to blood pressure and cholesterol improvement among patients at elevated risk of atherosclerotic cardiovascular disease. Am Heart J. 2024 Dec;278:208-222. doi: 10.1016/j.ahj.2024.09.029. Epub 2024 Sep 27.
PMID: 39341482DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Volpp, MD, PhD
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2023
First Posted
October 2, 2023
Study Start
March 11, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03