Penn Medicine Healthy Heart

University of Pennsylvania

Status: Enrolling

Conditions: Hypertension; Hyperlipidemias

Treatments: Behavioral: Penn Med Healthy Heart Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06062394

851832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,980 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,980 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

Penn Med Healthy Heart Program

Experimental group

Description:

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

Treatment:

Behavioral: Penn Med Healthy Heart Program