Effect of Electronic Reminders, Financial Incentives, and Social Support on Outcomes After Myocardial Infarction: The HeartStrong Randomized Clinical Trial

Abstract

Importance: Adherence to medications prescribed after acute myocardial infarction (AMI) is low. Wireless technology and behavioral economic approaches have shown promise in improving health behaviors.

Objective: To determine whether a system of medication reminders using financial incentives and social support delays subsequent vascular events in patients following AMI compared with usual care.

Design, setting, and participants: Two-arm, randomized clinical trial with a 12-month intervention conducted from 2013 through 2016. Investigators were blinded to study group, but participants were not. Design was a health plan-intermediated intervention for members of several health plans. We recruited 1509 participants from 7179 contacted AMI survivors (insured with 5 large US insurers nationally or with Medicare fee-for-service at the University of Pennsylvania Health System). Patients aged 18 to 80 years were eligible if currently prescribed at least 2 of 4 study medications (statin, aspirin, β-blocker, antiplatelet agent), and were hospital inpatients for 1 to 180 days and discharged home with a principal diagnosis of AMI.

Interventions: Patients were randomized 2:1 to an intervention using electronic pill bottles combined with lottery incentives and social support for medication adherence (1003 patients), or to usual care (506 patients).

Main outcomes and measures: Primary outcome was time to first vascular rehospitalization or death. Secondary outcomes were time to first all-cause rehospitalization, total number of repeated hospitalizations, medication adherence, and total medical costs.

Results: A total of 35.5% of participants were female (n = 536); mean (SD) age was 61.0 (10.3) years. There were no statistically significant differences between study arms in time to first rehospitalization for a vascular event or death (hazard ratio, 1.04; 95% CI, 0.71 to 1.52; P = .84), time to first all-cause rehospitalization (hazard ratio, 0.89; 95% CI, 0.73 to 1.09; P = .27), or total number of repeated hospitalizations (hazard ratio, 0.94; 95% CI, 0.60 to 1.48; P = .79). Mean (SD) medication adherence did not differ between control (0.42 [0.39]) and intervention (0.46 [0.39]) (difference, 0.04; 95% CI, -0.01 to 0.09; P = .10). Mean (SD) medical costs in 12 months following enrollment did not differ between control ($29 811 [$74 850]) and intervention ($24 038 [$66 915]) (difference, -$5773; 95% CI, -$13 682 to $2137; P = .15).

Conclusions and relevance: A compound intervention integrating wireless pill bottles, lottery-based incentives, and social support did not significantly improve medication adherence or vascular readmission outcomes for AMI survivors.

Trial registration: clinicaltrials.gov Identifier: NCT01800201.

Conflict of interest statement

Conflict of Interest Disclosures: Drs Volpp and Asch are principals and owners of VAL Health. Dr Volpp has served as a consultant for CVS Caremark and received grants from CVS Caremark, Hawaii Medical Services Association, Humana, Merck, Weight Watchers, and Discovery (South Africa). Dr Troxel serves on the Scientific Advisory Board of VAL Health. The authors who are employed by commercial insurance companies are salaried employees of these companies. Ms Levin and Mr Relish are salaried employees of Humana Inc. Dr Negin is a salaried employee of Horizon Blue Cross Blue Shield of New Jersey. Drs Smith-McLallen and Snyder are salaried employees of Independence Blue Cross. Dr Spettell is a salaried employee of Aetna. No other disclosures are reported.

Figures

Figure 1.. Consolidated Standards of Reporting Trials Diagram

aReasons for withdrawal: 2 participants withdrew because they were unhappy that they were placed in the control group; 1 did not want to use the GlowCap device; 2 enrolled but later were concerned about confidentiality and withdrew; 1 was withdrawn by the study investigators due to concern about competency to consent.

Figure 2.. Kaplan-Meier Curves for Hospitalization