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 — BEHAVIORAL1. 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 — BEHAVIORALThe 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Francisco General Hospital Emergency Department | San Francisco | California | 94110 | - |
| University of California San Francisco Parnassus | San Francisco | California | 94143 | - |
| Duke University Hospital | Durham | North Carolina | 27708 | - |
| Jefferson Methodist Hospital | Philadelphia | Pennsylvania | 19148 | - |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | - |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | - |
| Baylor College of Medicine | Houston | Texas | 77030 | - |
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