Clinical trial NCT06062394: Penn Medicine Healthy Heart
Official title: Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Hyperlipidemias
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 1980
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Difference in mean Systolic Blood Pressure (SBP)
timeFrame: 6-month period
measure: Difference in mean LDL-c
timeFrame: 6-month period
Secondary outcomes:
measure: Engagement in the BP intervention
timeFrame: 6-month period
measure: Difference in Diastolic Blood Pressure (DBP)
timeFrame: 6-month period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: