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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | This group will not receive the intervention and will continue with usual care. | |
| Penn Med Healthy Heart Program | Experimental | The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penn Med Healthy Heart Program | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Patients on PCSK9 inhibitors
Documented statin allergy/ or intolerance in the EMR
Pregnancy
Breast feeding
Markedly shortened life expectancy including:
Is a non-English speaker requiring a translator
Patients who do not have a cell phone
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Clark, MPH | Contact | 215-746-4428 | kayla.clark@pennmedicine.upenn.edu | |
| Laurie Norton, MA, MBE | Contact | Laurie.Norton@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Volpp, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39341482 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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|
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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 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |