Penn Medicine Healthy Heart

March 10, 2026 updated by: University of Pennsylvania

Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1980

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
This group will not receive the intervention and will continue with usual care.
Experimental: Penn Med Healthy Heart Program
The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
Behavioral: Penn Med Healthy Heart Program
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.
Other Names:
  • PMHH
  • HDPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean Systolic Blood Pressure (SBP)
Time Frame: 6-month period
Whether mean SBP is improved among those assigned to intervention vs those assigned to control
6-month period
Difference in mean LDL-c
Time Frame: 6-month period
Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control
6-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement in the BP intervention
Time Frame: 6-month period
Engagement in the BP intervention as measured by number of participants who agree to receive blood pressure monitor
6-month period
Difference in Diastolic Blood Pressure (DBP)
Time Frame: 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
6-month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Kevin Volpp, MD, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 851832

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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