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.

Autor: Volpp KG; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Wharton School, University of Pennsylvania, Philadelphia PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA. Electronic address: Volpp70@wharton.upenn.edu., Mahraj K; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Penn Medicine Center for Health Care Transformation and Innovation, Philadelphia, PA., Norton LA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Asch DA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Wharton School, University of Pennsylvania, Philadelphia PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Glanz K; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; School of Nursing, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Mehta SJ; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Medicine Center for Health Care Transformation and Innovation, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Balasta M; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Kellum W; Penn Medicine, Lancaster General Hospital, Lancaster, PA., Wood J; Penn Medicine, Lancaster General Hospital, Lancaster, PA., Russell LB; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Fanaroff AC; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Bakshi S; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Jacoby D; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Cohen JB; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Press MJ; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Clark K; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Zhu J; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Rareside C; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Ashcraft LE; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Health Equity Research and Promotion, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; Penn Implementation Science Center, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA., Snider C; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Medicine Center for Health Care Transformation and Innovation, Philadelphia, PA., Putt ME; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2024 Dec; Vol. 278, pp. 208-222. Date of Electronic Publication: 2024 Sep 27.
DOI: 10.1016/j.ahj.2024.09.029
Abstrakt: Rationales: Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Suboptimal control of hypertension and hyperlipidemia are common factors contributing to ASCVD risk. The Penn Medicine Healthy Heart (PMHH) Study is a randomized clinical trial testing the effectiveness of a system designed to offload work from primary care clinicians and improve patient follow-through with risk reduction strategies by using a centralized team of nonclinical navigators and advanced practice providers, remote monitoring, and bi-directional text messaging, augmented by behavioral science engagement strategies. The intervention builds on prior nonrandomized evaluations of these design elements that demonstrated significant improvement in patients' systolic blood pressure and LDL Cholesterol (LDL-C).
Primary Hypothesis: Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention.
Design: Randomized clinical trial of Penn Medicine Healthy Heart in patients aged 35-80 years at elevated risk of ASCVD whose systolic blood pressure and LDL-C are not well controlled. The intervention consists of 4 modules that address blood pressure management, lipid management, nutrition, and smoking cessation, offered in a phased approach to give the participant time to learn about each topic, adopt any recommendations, and build a relationship with the care team.
Sites: University of Pennsylvania Health System at primary care practices located in inner-city urban and rural/semi-rural areas.
Primary Outcomes: Improvement in systolic blood pressure and LDL-C.
Secondary Outcomes: Cost-effectiveness analyses are planned to evaluate the health care costs and health outcomes of the intervention approach. An implementation evaluation is planned to understand factors influencing success of the intervention.
Estimated Enrollment: 2,420 active patients of Penn Medicine primary care practices who have clinical ASCVD, or who are at elevated risk for ASCVD, and who are (a) not on statins or have LDL-C >100 despite being on statins and (b) had systolic blood pressure >140 at 2 recent ambulatory visits.
Enrollment Dates: March 2024-March 2025. The intervention will last 6 months with a 12-month follow-up to determine whether its effects persist.
Current Status: Enrolling (1,240 enrolled as of August 15, 2024) CLINICAL TRIAL REGISTRATION: NCT06062394.
Competing Interests: Conflict of interest Dr. Volpp is a Scientific Board member of THRIVE Global and a part owner of VALHealth, a behavioral economics consulting firm and has received research funding and consulting support from the American Heart Association. Dr. Asch is also a part owner of VALHealth and a Scientific Board member of THRIVE Global.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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