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Effect of Messaging on Pragmatic Outcomes Within an Integrated Healthcare System: a Randomized Trial (EMPOWeR)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
Kaiser Permanente Southern California, Department of Research & Evaluation
RECRUITING
Pasadena
Contact Information
Primary
Annette Regan, PhD
annette.k.regan@kp.org
626-760-2482
Backup
Zendi S Yha, BS
zendi.s.yha@kp.org
626-372-5637
Time Frame
Start Date: 2026-09-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 1300000
Treatments
No_intervention: Usual Care
Standard COVID-19 vaccination reminder message sent as part of usual care.
Experimental: A. Choice-framed
Intervention arm tests the effects of choice-framed communication to increase patient's awareness of their available choices of COVID-19 vaccines, compared with usual care.
Experimental: B. Choice + vaccine platform-framed
Intervention arm tests the effects of choice-framed communication to increase patients' awareness of their available choices of COVID-19 vaccines AND explain differences in vaccine composition and mechanisms of protection by vaccine type, compared with usual care.
Experimental: C. Choice + HCP trust-framed
Intervention arm tests the effects of choice-framed communication to increase patients' awareness of their available choices of COVID-19 vaccines AND emphasizes the support of healthcare personnel (HCP) for both vaccine options, compared with usual care.
Experimental: D. Choice + reactogenicity-framed
Intervention arm tests the effects of choice-framed communication to increase patients' awareness of their available choices of COVID-19 vaccines AND information about expected side effects, compared with usual care.
Related Therapeutic Areas
Sponsors
Leads: Kaiser Permanente
Collaborators: Sanofi

This content was sourced from clinicaltrials.gov