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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
Rationale and design of a randomized trial of automated hovering for post-myocardial infarction patients: The
Andrea B Troxel1, David A Asch1, Shivan J Mehta1
1University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Insights
The HeartStrong trial uses behavioral economics and technology to improve medication adherence for patients with coronary artery disease, aiming to reduce cardiovascular events and revascularization procedures.
Area of Science:
- Cardiovascular Disease Research
- Behavioral Economics in Healthcare
- Clinical Trial Innovation
Background:
- Coronary artery disease is a leading cause of death.
- Medication adherence is critically low, increasing event risk.
- Effective interventions are needed to improve patient outcomes.
Purpose of the Study:
- To evaluate the HeartStrong program, a novel intervention for medication adherence.
- To leverage behavioral economics and technology for enhanced patient care.
- To reduce repeat cardiovascular events and revascularization procedures.
Main Methods:
- National randomized trial with 1,509 patients post-acute myocardial infarction.
- Intervention group receives behavioral economics-based support and technology.
- Control group receives usual care.
- Wireless pill bottles and remote feedback automate procedures.
- Rapid-cycle innovation integrated into trial design.
Main Results:
- Primary outcome: time to first fatal or nonfatal acute vascular event or revascularization.
- Includes acute myocardial infarction, unstable angina, stroke, acute coronary syndrome, or death.
- Data collected via insurance partners and direct patient contact.
- 1-year intervention period.
Conclusions:
- The HeartStrong program offers a state-of-the-art behavioral economic intervention.
- Features include tailored patient support and streamlined processes.
- Utilizes technology for efficient implementation and data collection.
- Aims to improve outcomes centrally important to patients.
Background:
Coronary artery disease is the single leading cause of death in the United States, and medications can significantly reduce the rate of repeat cardiovascular events and treatment procedures. Adherence to these medications, however, is very low.
Methods:
HeartStrong is a national randomized trial offering 3 innovations. First, the intervention is built on concepts from behavioral economics that we expect to enhance its effectiveness. Second, the implementation of the trial takes advantage of new technology, including wireless pill bottles and remote feedback, to substantially automate procedures. Third, the trial's design includes an enhancement of the standard randomized clinical trial that allows rapid-cycle innovation and ongoing program enhancement.
Results:
Using a system involving direct data feeds from 6 insurance partners followed by mail, telephone, and email contact, we enrolled 1,509 patients discharged from the hospital with acute myocardial infarction in a 2:1 ratio of intervention:usual care. The intervention period lasts 1 year; the primary outcome is time to first fatal or nonfatal acute vascular event or revascularization, including acute myocardial infarction, unstable angina, stroke, acute coronary syndrome admission, or death.
Conclusions:
Our randomized controlled trial of the HeartStrong program will provide an evaluation of a state-of-the-art behavioral economic intervention with a number of important pragmatic features. These include a tailored intervention responding to patient activity, streamlining of consent and implementation processes using new technologies, outcomes centrally important to patients, and the ability to implement rapid-cycle innovation.
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