Penn Medicine Healthy Heart

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 Pen

Первичные конечные точки

• Difference in mean Systolic Blood Pressure (SBP) [Срок оценки: 6-month period]
• Difference in mean LDL-c [Срок оценки: 6-month period]

Вторичные конечные точки (2)

• Engagement in the BP intervention [Срок оценки: 6-month period]
• Difference in Diastolic Blood Pressure (DBP) [Срок оценки: 6-month period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Patients who do not have a cell phone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Penn Medicine — Philadelphia

Публикации

• 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 PMID 39341482

Идентификаторы

NCT: NCT06062394 · 851832

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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