R01MD019189

Comparing a novel telehealth-enabled hybrid cardiac rehabilitation program to clinic-based cardiac rehabilitation for improving patient engagement, functional outcomes, and health equity after ACS - Project abstract

Cardiac rehabilitation (CR)—which involves exercise training, patient education, and health behavior modification—is a comprehensive intervention traditionally delivered in clinic-based settings, with the highest recommendation and level of evidence classification (i.e., Class I, Level A) for secondary prevention.

Traditional CR significantly reduces rates of reinfarction (by 47%) and both cardiac (36%) and all-cause mortality (26%) in acute coronary syndrome (ACS) survivors, an extremely sedentary population whose functional status and health-related quality of life (HRQOL) improve after CR participation.

Despite the well-established effectiveness of traditional CR—benefits achieved through continued program participation (i.e., adherence), fewer than 10% of eligible ACS patients in the US who initiate CR (<30%) attend all prescribed CR sessions, with even lower rates among racial and ethnic minoritized groups.

Dismal participation in traditional CR programs and stark utilization disparities that have endured for decades highlight the need to design nontraditional CR models (e.g., virtual, hybrid) and rigorously test whether such models can deliver the same quality of traditional CR while equitably improving patient participation among diverse groups of cardiac patients.

To address this need, our group combined user-centered design (UCD) and implementation science (IMS) principles and methods to design and test the feasibility of a telehealth-enhanced hybrid CR program (TeleHeartCR; mixture of in-person, clinic and virtual, home sessions with a telehealth platform that supports real-time monitoring and electronic health record [EHR] data integration).

This program targets patient-, provider-, and system-level barriers in a large hospital setting that serves diverse patients.

Now, we propose to conduct a single-site, single-blind, two-arm, parallel group, randomized controlled trial to determine the degree to which TeleHeartCR equitably improves CR participation and clinical outcomes relative to traditional CR among ACS patients.

We hypothesize that participants allocated to TeleHeartCR will demonstrate greater program adherence (% of CR sessions completed) and non-inferior functional capacity (pre-to-post program change in six-minute walk test [6MWT] distance) vs participants allocated to traditional CR.

Both CR programs include 24 CR sessions over 3 months.

Program attendance, and a 6MWT at baseline and program completion, will be collected and extracted from the EHR.

Self-reported program acceptability, appropriateness, and HRQOL will be secondary outcomes.

We will also explore the comparative costs and cost-effectiveness (TeleHeartCR vs. traditional CR), as well as whether racially, ethnically, and socioeconomically minoritized groups particularly benefit.

Findings will inform the design and implementation of innovative hybrid delivery models to achieve equitable utilization of established interventions in hospital settings that serve diverse patients.

More broadly, if our hypotheses are supported, this study will illustrate the power of UCD and IMS to deploy technology in the service of closing evidence-to-practice gaps and reducing disparities in healthcare access and persistence.

The Trustees Of Columbia University In The City Of New York

NOT APPLICABLE

93.307 - Minority Health and Health Disparities Research

National Institute for Minority Health and Health Disparities (NIMHD) [HHS - NIH]

New York, New York 100323720 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 380% from $821,694 to $3,943,721.