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

Detailed Description

I. Overview On January 22, 2020, Acting Health and Human Services Secretary Norris Cochran
declared COVID-19 a national public health emergency, an action that eventually enabled
emergency authorization for free COVID-19 vaccines, testing and treatments. This public
health declaration has been renewed seven times for 90-day intervals, as required under
section 319 of the Public Health Service (PHS) Act. Under this declaration over the past two
years, the US government has provided full support and distribution of COVID-19 vaccines and
therapeutics (antibody therapies, remdesivir, and nirmatrelvir/ritonavir), such that they
have been widely available and free of charge to all Americans. Although these measures have
not, by any means, ended the pandemic, it is clear from multiple epidemiologic modeling
studies that they have decreased hospitalizations and saved hundreds of thousands of lives.
They have also led to a narrowing of the profound morbidity and mortality disparities gap
that was seen in minority populations in the first two waves of the pandemic.

The PROCOVAXED trial was a multicenter study that sought to decrease COVID-19 vaccine
hesitancy and increase COVID-19 vaccine uptake through the use of vaccine messaging platforms
in the emergency department (ED). In this trial, investigators found that implementation of
our COVID-19 messaging platforms (videos, information sheets and scripted, direct messaging)
were associated with greater COVID-19 vaccine acceptance and uptake among unvaccinated ED
patients (Rodriguez RM, Nichol G, Eucker SA, et al. Effect of COVID-19 Vaccine Messaging
Platforms in Emergency Departments on Vaccine Acceptance and Uptake: A Cluster Randomized
Clinical Trial. JAMA Intern Med. 2023;183(2):115-123. doi:10.1001/jamainternmed.2022.5909).

In January 2022, the investigators extended PROCOVAXED by shifting the focus to vaccinated ED
patients to examine the timely and critically important topic of booster vaccine hesitancy in
underserved ED populations. To better characterize COVID-19 booster hesitancy, the
investigators performed a cross-sectional study at five high-volume, safety-net hospital EDs
in four cities (San Francisco, Philadelphia, Seattle, and Durham, NC) using survey tools to
gather quantitative data on vaccination status, demographic variables, usual source of care,
and attitudes toward booster vaccination. Of 771 participants who had completed their full
initial series, 316 (41%) had not received any booster vaccine. Among these 316 non-boosted
participants, 179 (57%, 95% CI 51-62) stated they would decline or were unsure whether they
would accept a booster vaccine if it was offered to them (i.e., booster-hesitant).
Investigators found the following associations with booster vaccine hesitancy: age 35-49
years vs age 18-34 years (OR 1.16, 95% CI 0.99-1.36); Asian vs White race (OR 0.21, 95% CI
0.05-0.93); Hispanic/Latino vs White ethnicity (OR 1.59, 95% CI 0.82-3.09); primary language
non-English vs English (OR 2.35, 95% CI 1.49-3.71); and Republican vs Democrat party
affiliation (OR 6.07, 95% CI 4.21-8.75). The three most common reasons for booster vaccine
hesitancy were a preference to wait for more information (25%), concerns about side effects
and safety (24%), and "I don't need one because I'm fully vaccinated" (20%).

Recognizing the ED as a unique opportunity to address COVID-19 booster vaccine hesitancy in
underserved populations, the investigators will launch the PROmotion of COVID-19 BOOSTer
VA(X)ccination in the Emergency Department (PROBOOSTVAXED) trial as an extension of the
PROCOVAXED trial, seeking to increase COVID-19 booster vaccine acceptance and uptake among
vaccinated ED patients. Because of Omicron variant-associated surges during the COVID-19
pandemic with corresponding research staff illness and ED overcrowding, the investigators
found wide week-to-week fluctuations in enrollment in the PROCOVAXED study. To reduce this
variability of enrollment, the investigators have changed the unit of randomization from
1-week to 1-day in the PROBOOSTVAXED trial.

As of May 11, 2023, the COVID-19 public health emergency ended. Consequently, not only are
the costs for vaccines, testing, and treatments shifted to health insurers and patients via
commercial payment mechanisms, but COVID-19 vaccines are no longer available in some EDs.
Since our research focuses on the delivery and availability of vaccines to underserved
populations whose only health care access occurs in EDs, the team believes that this
represents a potential barrier to 30-day vaccine uptake in these populations. The
investigators have been informed that only some of the PROBOOSTVAXED study sites will have
COVID-19 vaccines available for distribution in the ED, and this availability is subject to
change throughout the study period. Nevertheless, the team will proceed with the same
research protocol, however, the investigators feel it is important to examine how ED vaccine
availability will affect 30-day vaccine uptake in underserved populations. They will
therefore be performing additional subgroup analyses that compare 30-day vaccine uptake among
sites with available COVID-19 vaccine to those without for the intervention and control
arms.They will also evaluate whether patient costs of vaccines are a deterrent to acceptance
and uptake.

While the sample size calculation for this research is derived from Aim 1, the investigators
emphasize that this is a pragmatic study in which they seek to evaluate the fluid real-world
changes in COVID-19 vaccine availability and funding. As stated above, there have been (and
likely will continue to be) changes in payment for and availability of vaccines in EDs.

The investigators therefore have developed our protocol and aims below to assess the impact
of these changes.

Aim1: To determine whether implementation of COVID-19 booster vaccine trusted messaging
platforms is associated with increased booster vaccine uptake in ED patients. At five EDs
(Zuckerberg San Francisco General, UCSF Parnassus Medical Center [San Francisco, CA], Thomas
Jefferson University Hospital [Philadelphia, PA], Ben Taub Hospital [Houston, TX], Duke
University Medical Center [Durham, NC]), investigators will conduct a cluster-randomized
controlled trial of the implementation of PROBOOSTVAXED trusted messaging platforms, with
30-day booster vaccine uptake as the primary outcome and booster vaccine uptake in the ED as
a secondary outcome. Hypothesis: Implementation of PROBOOSTVAXED trusted messaging platforms
in EDs will be associated with increased 30-day booster vaccine uptake in vaccinated ED
patients.

Aim 1a: To determine whether implementation of COVID-19 booster vaccine trusted messaging
platforms in EDs is associated with increased booster vaccine acceptance in ED patients. For
this aim, booster vaccine acceptance in the ED assessed via ED survey will be the primary
outcome. Hypothesis: Implementation of PROBOOSTVAXED trusted messaging platforms in EDs will
be associated with increased booster vaccine acceptance in ED patients.

Aim 2: To determine whether implementation of a protocol in which ED patients are asked
whether they will accept a COVID-19 booster vaccine in the ED is associated with increased
booster vaccine uptake in ED patients. Hypothesis: Implementation of an ED protocol in which
patients are asked whether they will accept a COVID-19 booster vaccine will be associated
with increased 30-day booster vaccine uptake in ED patients.

Aim 3: To compare vaccine uptake (during the index ED visit and 30 days post visit) between
sites that have COVID-19 booster vaccine available and those that do not.

Aim 3a: To compare vaccine acceptance and 30-day uptake among patients with health insurance
versus those without health insurance (evaluating the effects of patient vaccine cost on
acceptance and uptake).

Aim 4: To compare COVID-19 vaccine uptake in this current study with data gathered in our
previous COVID-19 vaccine messaging trial.

General Design: This is a three-arm cluster-randomized controlled trial (CRCT).

Recruiting
COVID-19

Behavioral: Vaccine Messaging

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.
Printed materials - one page information sheets handed to subjects by CRCs.
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?"

Eligibility Criteria

Inclusion Criteria:

1. Age > 18 years

2. Presenting to ED

3. No receipt of COVID-19 booster within prior 6 months

4. Able to provide informed consent

5. Fluent in English or Spanish

6. Anticipated ability to complete study intervention in ED i.e., able to watch a
3-minute videoclip

Exclusion Criteria:

1. Major trauma such that it will preclude survey

2. Inability to participate in a survey because of intoxication, altered mental status,
or critical illness

3. Incarceration

4. Psychiatric hold

5. Patients who state that they have already received a bivalent COVID-19 booster vaccine
or other COVID-19 vaccine within the prior 6 months

6. Patients who are in the ED for suspected acute COVID-19

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

San Francisco General Hospital Emergency Department
San Francisco, California, United States

University of California San Francisco Parnassus
San Francisco, California, United States

Duke University Hospital
Durham, North Carolina, United States

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States

Jefferson Methodist Hospital
Philadelphia, Pennsylvania, United States

Baylor College of Medicine
Houston, Texas, United States

Contacts

Robert Rodriguez, MD
925-457-2145
robert.rodriguez@ucsf.edu

Melanie Molina, MD
Melanie.Molina@ucsf.edu

Robert Rodriguez, MD, Principal Investigator
University of California, San Francisco

University of California, San Francisco
NCT Number
Keywords
Covid-19
Health Disparities
booster vaccines
healthcare access
Vaccination
Public Health
MeSH Terms
COVID-19
Emergencies
Vaccines