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

Summary

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

Conditions

• COVID-19

Interventions

BEHAVIORAL

Vaccine Messaging

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.

BEHAVIORAL

Vaccine Acceptance Question

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?"

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Pfizer

  collaborator INDUSTRY

• Duke University

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Robert Rodriguez, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-19

Primary Completion

2024-07-18

Completion

2024-08-18

Countries

• United States

Study Locations