Rationale and design of a randomized trial of automated hovering for post-myocardial infarction patients: The HeartStrong program.
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.
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA. Electronic address: atroxel@mail.med.upenn.edu.
Andrea B
AB
Troxel
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
David A
DA
Asch
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Shivan J
SJ
Mehta
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Laurie
L
Norton
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Devon
D
Taylor
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Tirza A
TA
Calderon
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Raymond
R
Lim
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Jingsan
J
Zhu
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Daniel M
DM
Kolansky
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Brian M
BM
Drachman
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Kevin G
KG
Volpp
D054058:Acute Coronary Syndrome / Q000453:epidemiology; D000789:Angina, Unstable / Q000453:epidemiology; D001331:Automation; D003324:Coronary Artery Disease; D019468:Disease Management; D060909:Economics, Behavioral; D015438:Health Behavior; D006760:Hospitalization; D006801:Humans; D055118:Medication Adherence; D009026:Mortality; D009203:Myocardial Infarction / Q000628:therapy*; D016016:Proportional Hazards Models; D012008:Recurrence; D055502:Secondary Prevention / Q000379:methods*; D020521:Stroke / Q000453:epidemiology