Penn Medicine Healthy Heart

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: Hypertension; Hyperlipidemias
• Intervention / Treatment: Behavioral: Penn Med Healthy Heart Program

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

• Study Contact: Name: Kayla Clark, MPH; Phone Number: 215-746-4428; Email: Kayla.Clark@pennmedicine.upenn.edu
• Study Contact Backup: Name: Laurie Norton, MA, MBE; Email: Laurie.Norton@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine
      • Contact: Kayla Clark, MPH; Phone Number: 215-746-4428; Email: Kayla.Clark@pennmedicine.upenn.edu
      • Contact: Laurie A Norton, MA, MBE; Phone Number: 215-573-8799; Email: Laurie.Norton@pennmedicine.upenn.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in the BP intervention	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)	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

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

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

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): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• 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