JAMA published 5-year RCT results for Million Hearts - a national HHS pay-for-performance model to prevent heart attacks & strokes in Medicare patients. Quick take: No discernible impact on the study’s primary health or cost outcomes (health findings are misreported as positive in JAMA). Continued below.

Program:

  • Launched in 2017, the HHS/CMS Million Hearts® Model pays healthcare providers to (i) use a novel risk assessment tool to identify fee-for-service Medicare patients at risk of heart attack or stroke, & (ii) provide these patients with cardiovascular care management services.

Study Design:

  • The study randomly assigned 516 organizations (primary care & specialty practices, health centers, & hospital outpatient departments) to a treatment group vs a usual-care control group. These organizations enrolled a patient sample of about 219,000 over two years.

Findings:

  • On the pre-specified primary 5-year outcomes (highlighted in blue, above): There was no impact on first-time heart attacks & strokes for high-risk patients (10.6% T vs 10.7% C), nor on Medicare Part A&B spending/month ($960 T vs $958 C). The impact on CVD risk scores of high-risk patients at 5 years isn't reported.  

  • The study changed its primary outcomes after receiving the early outcome data in January 2019 to those now posted on clinicaltrials.gov (shown above, right), but even so, none of the impacts on these 4 primary outcomes were statistically significant at conventional levels.

  • Specifically: First-time heart attack & stroke was 10.6% T vs 10.7% C (p=0.63) for high-risk patients, and 7.8% T vs 8.1% C (p=0.09) for high+medium risk patients. CVD-related spending per month was $51 T vs $54 C (p=0.23) for high-risk patients, & $38 T vs $39 C (p=0.16) for high+medium risk patients.

Comment:

  • The JAMA study abstract unfortunately portrays the health impacts as positive based on selectively-reported and/or post-hoc exploratory outcomes. Here's the JAMA article & other relevant study reports (here and here).

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