Penn Medicine Healthy Heart

NCT ID: NCT06062394

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1980 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2026-04-30

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.

Conditions

Hypertension; Hyperlipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Usual Care

This group will not receive the intervention and will continue with usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Penn Med Healthy Heart Program

The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.

Group Type: EXPERIMENTAL

Penn Med Healthy Heart Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PMHH; HDPP

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Volpp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Medicine

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kayla Clark, MPH

Role: CONTACT

kayla.clark@pennmedicine.upenn.edu

215-746-4428

Laurie Norton, MA, MBE

Role: CONTACT

Laurie.Norton@pennmedicine.upenn.edu

Facility Contacts

Laurie A Norton, MA, MBE

Role: primary

Laurie.Norton@pennmedicine.upenn.edu

215-573-8799

Kayla Clark, MPH

Role: backup

Kayla.Clark@pennmedicine.upenn.edu

215-746-4428

References

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.

Reference Type: DERIVED

PMID: 39341482 (View on PubMed)

Other Identifiers

851832

Identifier Type: -

Identifier Source: org_study_id