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Effect of Messaging on Pragmatic Outcomes Within an Integrated Healthcare System

Study acronym: EMPOWeR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Sep 28, 2026 to Sep 29, 2026
    • Site details revised
  2. Eligibility criteria expanded, about 24 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
COVID-19 vaccination among patients at high risk for severe disease has declined in the United States since 2022. Prior research, including discrete choice experiments (DCEs), has demonstrated that vaccine preferences are influenced by attributes such as effectiveness, safety, convenience, and protection against severe disease. Although DCEs provide valuable insights into stated vaccine preferences and decision-making, they rely on hypothetical scenarios and cannot directly assess how vaccine attributes influence real-world vaccine uptake. Additional research is needed to understand the relationship between vaccine characteristics and observed COVID-19 vaccination behavior in routine clinical practice. The EMPOWeR study is a pragmatic randomized controlled trial conducted within Kaiser Permanente Southern California (KPSC) to evaluate the effect of immunization messages and reminders that highlight COVID-19 vaccine choices on vaccine uptake. The primary research questions are: 1. Does having a choice in COVID-19 vaccine platform affect vaccine uptake among patients at high-risk of severe disease? 1a. Does having a choice in COVID-19 vaccine platform affect vaccine uptake among patients at high-risk of severe disease, when differences in vaccine platform are highlighted? 1b. Does having a choice in COVID-19 vaccine platform affect vaccine uptake among patients at high-risk of severe disease, when a trusted healthcare professional (HCP) endorses both vaccine options? 1c. Does having a choice in COVID-19 vaccine platform affect vaccine uptake among patients at high-risk of severe disease, when vaccine reactogenicity is highlighted? A secondary research question is: 2. Does having a choice in COVID-19 vaccine additionally increase uptake of influenza vaccine? During the 2026-2027 respiratory virus season, eligible KPSC members who are at high-risk of severe COVID-19 will be randomly assigned to receive a standard reminder message or a reminder message with additional information about available COVID-19 vaccine options.
Trial Details
NCT Number NCT07838038
Lead Sponsor Kaiser Permanente
Collaborators: Sanofi
Conditions
(from sponsor)		 Covid-19 Vaccination
Related terms Patient Preference
Enrollment 1,300,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov