Penn Medicine Healthy Heart

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Hyperlipidemias

Intervention / Treatment
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* Behavioral: Penn Med Healthy Heart Program


Participation Criteria
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Eligibility Criteria
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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: metastatic cancer hospice End Stage Renal Disease Congestive Heart Failure Dementia Is a non-English speaker requiring a translator

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>This group will not receive the intervention and will continue with usual care. | |
| Experimental: Penn Med Healthy Heart Program<br>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<br>* 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.<br>* Other names: HDPP;|

What is the study measuring?
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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 |
| --- | --- | --- |
| Difference in mean Systolic Blood Pressure (SBP) | Whether mean SBP is improved among those who engaged in the intervention i.e., the average improvement for intervention versus control for those who would have, counter-factually, engaged in the intervention if assigned intervention | 6-month period | 
| Difference in mean LDL-c | Whether mean LDL-c is improved among those who engaged in the intervention i.e., the average improvement for intervention versus control for those who would have, counter-factually, engaged in the intervention if assigned intervention | 6-month period |