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Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.
Cocoros, Noelle M; Gurwitz, Jerry H; Cziraky, Mark J; Granger, Christopher B; Harkins, Thomas; Haynes, Kevin; Li, Xiaojuan; Parlett, Lauren; Seeger, John D; Singh, Sonal; McMahill-Walraven, Cheryl N; Platt, Richard.
Afiliación
  • Cocoros NM; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Gurwitz JH; Meyers Health Care Institute, A Joint Endeavor of UMass Chan Medical School, Reliant Medical Group and Fallon Health, Worcester, MA, USA.
  • Cziraky MJ; HealthCore, Inc., Wilmington, DE, USA.
  • Granger CB; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Harkins T; Humana Healthcare Research, Inc., Louisville, KY, USA.
  • Haynes K; Janssen Research & Development, Titusville, PA, USA.
  • Li X; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Parlett L; HealthCore, Inc., Wilmington, DE, USA.
  • Seeger JD; Optum Epidemiology, Boston, MA, USA.
  • Singh S; Meyers Health Care Institute, A Joint Endeavor of UMass Chan Medical School, Reliant Medical Group and Fallon Health, Worcester, MA, USA.
  • McMahill-Walraven CN; CVS Health Clinical Trial Services, Blue Bell, PA, USA.
  • Platt R; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Clin Trials ; 20(4): 416-424, 2023 08.
Article en En | MEDLINE | ID: mdl-37322894
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Medicare Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Aged / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Medicare Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Aged / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido