PROmotion of COVID-19 BOOSTer VA(X)Ccination in the Emergency Department - PROBOOSTVAXED

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06156215
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vaccine Messaging — BEHAVIORAL
    1. Video clips - short (approximately 3-minute) Public Service Announcement type videos to be viewed by participant using a QR code on their smartphone. If no smartphone is available, the video will be shown to the participant on an iPad. 2. Printed materials - one page information sheets handed to subjects by CRCs. 3. Face to face messaging - short (\< 1 minute), scripted message from the patient's providers in the ED (nurse or provider) Each site will maintain a library of A. 5 versions of the videos - the version used in any participant will be tailored to that participant's stated race/ethnicity. B. 5 versions of printed flyers - likewise, the version will be tailored to the participant's stated race/ethnicity. C. 1 version of scripted message to be delivered in English or Spanish.
  • Vaccine Acceptance Question — BEHAVIORAL
    The last question in the Vaccine Acceptance Survey in both the Intervention M and Intervention Q arms of the study is "Would you accept the COVID-19 booster vaccine in the emergency department today if your doctor asked you?"

Study Details

The goal of this cluster randomized clinical trial is to test the efficacy of messaging interventions to increase booster vaccine uptake in adults in the emergency department(ED). The main question\[s\] and goals of this study are: * does the intervention of vaccine messaging increase booster vaccine uptake at 30 days post ED visit? * does the intervention of asking about vaccine acceptance increase booster vaccine uptake at 30 days post ED visit? * considering recent national changes to funding and availability of updated vaccines, the investigators will examine the effects of these changes on vaccine acceptance and uptake in ED populations. Specifically, they will stratify EDs and ED patients according to the ED availability of vaccines, and they will also examine whether costs and availability of vaccines are a deterrent to patient acceptance and uptake of vaccines

Key Dates

Start date
Jan 19, 2024
Status verified
Aug 2025
Primary completion
Jul 18, 2024
Completion
Aug 18, 2024

Study Design

Enrollment
919 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: PROBOOSTVAXED Intervention M (Messaging + Vaccine Question)
    * Vaccine messaging * Vaccine acceptance question All patients will receive an Intake Survey assessing their demographic and vaccination information. At the end of the Intake Survey, the Clinical Research Coordinator (CRC) will deliver the booster vaccine information flyer and ask the patient if they will watch a short video on booster vaccines. If they agree, the CRC will give them a QR code to view the video on their smartphone or an iPad. After finishing with the video, the CRC will tell the subject that they will be back for the Vaccine Acceptance survey. The CRC will then leave the room and ask the patient's primary provider to deliver the booster vaccine scripted message. This message is short and should not significantly impact provider workflow. Vaccine Acceptance Survey (Post-Intervention) in the ED: We will administer the Vaccine Acceptance Survey at 30 minutes to 3 hours after the Intake Survey.
  • Active Comparator: Intervention Q (Vaccine Question, No Messaging)
    * No vaccine messaging * Vaccine acceptance question asked in the Vaccine Acceptance Survey Vaccine Acceptance Survey: We will administer the Vaccine Acceptance Survey at some time (generally 30 minutes but up to 3 hours) after the Intake Survey. The surveys in the control group retain the same key primary and secondary outcome questions as in the intervention group Vaccine Acceptance surveys.
  • No Intervention: Control (No Messaging, No Vaccine Question)
    * No vaccine messaging * No vaccine acceptance question The workflow during this arm is identical to the Intervention Q arm except there will be no Vaccine Acceptance Question survey.

Primary Outcome Measure

Number of Participants With 30-day Booster Vaccine Uptake [ Time Frame: 30 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
San Francisco General Hospital Emergency DepartmentSan FranciscoCalifornia94110-
University of California San Francisco ParnassusSan FranciscoCalifornia94143-
Duke University HospitalDurhamNorth Carolina27708-
Jefferson Methodist HospitalPhiladelphiaPennsylvania19148-
Jefferson Torresdale HospitalPhiladelphiaPennsylvania19114-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Baylor College of MedicineHoustonTexas77030-

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