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Penn Medicine Healthy Heart

Primary Purpose

Hypertension, Hyperlipidemias

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Penn Med Healthy Heart Program
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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: metastatic cancer hospice End Stage Renal Disease Congestive Heart Failure Dementia Is a non-English speaker requiring a translator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual Care

    Penn Med Healthy Heart Program

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Difference in mean Systolic Blood Pressure (SBP)
    Whether mean SBP is improved among those assigned to intervention vs those assigned to control
    Difference in mean LDL-c
    Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    October 2, 2023
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062394
    Brief Title
    Penn Medicine Healthy Heart
    Official Title
    Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Hyperlipidemias

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    This group will not receive the intervention and will continue with usual care.
    Arm Title
    Penn Med Healthy Heart Program
    Arm Type
    Experimental
    Arm Description
    The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Penn Med Healthy Heart Program
    Other Intervention Name(s)
    PMHH, HDPP
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Difference in mean Systolic Blood Pressure (SBP)
    Description
    Whether mean SBP is improved among those assigned to intervention vs those assigned to control
    Time Frame
    6-month period
    Title
    Difference in mean LDL-c
    Description
    Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control
    Time Frame
    6-month period
    Secondary Outcome Measure Information:
    Title
    Difference in mean Systolic Blood Pressure (SBP)
    Description
    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
    Time Frame
    6-month period
    Title
    Difference in mean LDL-c
    Description
    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
    Time Frame
    6-month period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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: metastatic cancer hospice End Stage Renal Disease Congestive Heart Failure Dementia Is a non-English speaker requiring a translator
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kayla Clark, MPH
    Phone
    215-746-4428
    Email
    kayla.clark@pennmedicine.upenn.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laurie Norton, MA, MBE
    Email
    Laurie.Norton@pennmedicine.upenn.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Volpp, MD, PhD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Penn Medicine Healthy Heart

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