Penn Medicine Healthy Heart

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062394
• Other study ID #: 851832
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Kayla Clark, MPH
• Phone: 215-746-4428
• Email: kayla.clark[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1980
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hypertension

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.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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