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Effect of Messaging on Pragmatic Outcomes Within an Integrated Healthcare System

Kaiser Permanente · with Sanofi · NCT07838038

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
1300000
US sites recruiting
1
Study start
September 29, 2026
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • 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

  • 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.

Being studied: Vaccine choice message; Vaccine choice + platform-framed message; Vaccine choice + HCP trust-framed message; Vaccine choice + reactogenicity-framed message

Conditions: Covid-19 Vaccination

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Aged ≥18 years;
  • Active KPSC member;
  • Continuous membership from 27 August 2025 to 28 September 2026;
  • Members who are aged 65 years and older, or adults aged 18-64 years with at least one of the following health conditions that increases their risk for severe COVID-19 illness, including: a) asthma, b) cancer, c) ischemic stroke, d) intracerebral or subarachnoid hemorrhage, e) transient ischemic attack, f) chronic kidney disease, g) dialysis, h) bronchiectasis, i) chronic obstructive, pulmonary disease (COPD), j) pulmonary fibrosis, k) cystic fibrosis, l) pulmonary hypertension, m) cirrhosis, n) non-alcoholic fatty liver disease (NALD), o) alcoholic liver disease, p) autoimmune hepatitis, q) diabetes, r) heart failure, s) coronary artery disease, t) cardiomyopathy, u) HIV, v) obesity, w) essential hypertension, x) primary immunodeficiency and other underlying immunocompromising conditions, y) solid organ or blood stem cell transplant, z) tuberculosis;
  • No documented receipt of updated 2026-27 COVID-19 vaccine as of 28 September 2026;
  • Has valid email information.

Exclusion Criteria

  • Unable to receive or opted out of email communication.
  • People with unknown or missing sex.
  • People who cannot safely receive a COVID-19 vaccine, including those who had a severe allergic reaction to a previous COVID-19 vaccine or have a contraindication to COVID-19 vaccine or a vaccine ingredient, will not be included in the study.
  • People with metastatic or terminal illness, advanced illness, receiving hospice or palliative care, or resident in skilled nursing facilities.
  • People who are pregnant or currently breastfeeding.

Recruiting US locations

  • Kaiser Permanente Southern California, Department of Research & Evaluation

    Pasadena, CA 91101

    Site contact: Zendi S Yha, BS · 626-372-5637 · zendi.s.yha@kp.org

Study contacts (from the official record)

  • Annette Regan, PhD · 626-760-2482 · annette.k.regan@kp.org
  • Zendi S Yha, BS · 626-372-5637 · zendi.s.yha@kp.org
All vaccine studies in California →
Effect of Messaging on Pragmatic Outcomes Within an Integrated… (NCT07838038) | Bored Studies