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Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.

Publication ,  Journal Article
Cocoros, NM; Gurwitz, JH; Cziraky, MJ; Granger, CB; Harkins, T; Haynes, K; Li, X; Parlett, L; Seeger, JD; Singh, S; McMahill-Walraven, CN; Platt, R
Published in: Clin Trials
August 2023

BACKGROUND: There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes. METHODS: We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials. RESULTS: Information is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned. CONCLUSIONS: Studies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

August 2023

Volume

20

Issue

4

Start / End Page

416 / 424

Location

England

Related Subject Headings

  • United States
  • Statistics & Probability
  • Sample Size
  • Research Design
  • Pragmatic Clinical Trials as Topic
  • National Institutes of Health (U.S.)
  • Medicare
  • Humans
  • Aged
  • 5203 Clinical and health psychology
 

Citation

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Cocoros, N. M., Gurwitz, J. H., Cziraky, M. J., Granger, C. B., Harkins, T., Haynes, K., … Platt, R. (2023). Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple. Clin Trials, 20(4), 416–424. https://doi.org/10.1177/17407745231160459
Cocoros, Noelle M., Jerry H. Gurwitz, Mark J. Cziraky, Christopher B. Granger, Thomas Harkins, Kevin Haynes, Xiaojuan Li, et al. “Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.Clin Trials 20, no. 4 (August 2023): 416–24. https://doi.org/10.1177/17407745231160459.
Cocoros NM, Gurwitz JH, Cziraky MJ, Granger CB, Harkins T, Haynes K, et al. Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple. Clin Trials. 2023 Aug;20(4):416–24.
Cocoros, Noelle M., et al. “Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.Clin Trials, vol. 20, no. 4, Aug. 2023, pp. 416–24. Pubmed, doi:10.1177/17407745231160459.
Cocoros NM, Gurwitz JH, Cziraky MJ, Granger CB, Harkins T, Haynes K, Li X, Parlett L, Seeger JD, Singh S, McMahill-Walraven CN, Platt R. Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple. Clin Trials. 2023 Aug;20(4):416–424.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

August 2023

Volume

20

Issue

4

Start / End Page

416 / 424

Location

England

Related Subject Headings

  • United States
  • Statistics & Probability
  • Sample Size
  • Research Design
  • Pragmatic Clinical Trials as Topic
  • National Institutes of Health (U.S.)
  • Medicare
  • Humans
  • Aged
  • 5203 Clinical and health psychology