PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED (PROCOVAXED)
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|ClinicalTrials.gov Identifier: NCT05142332|
Recruitment Status : Not yet recruiting
First Posted : December 2, 2021
Last Update Posted : December 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid-19 Vaccine Influenza Vaccine||Other: Covid-19 vaccine education materials||Not Applicable|
Our preliminary work research at 15 ED sites across the US indicates that ED Usual Source of Care patients have particular health care access barriers, needs, and perceptions about vaccines (vaccine hesitancy) that require specific review beyond traditional (non-ED user) community engagement techniques. To gain insight about messaging that effectively addresses these barriers, needs, and perceptions, we will conduct one on one interviews and focus group meetings with ED Usual Source of Care Patients and community partners.
At five safety net EDs (Zuckerberg San Francisco General, Thomas Jefferson University Hospital [Philadelphia], Methodist Hospital [Philadelphia], Harborview Medical Center [Seattle], and Duke University Medical Center [Durham, NC], we will conduct a cluster-randomized, controlled trial of implementation of PROCOVAXED platforms, with COVID-19 and influenza vaccine acceptance rates on post-intervention ED surveys as the primary outcomes. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with increased acceptance of COVID-19 and influenza vaccines in ED patients.
One month after subjects' index ED visit enrollment in our PROCOVAXED implementation trial we will conduct electronic health record review and phone follow-up surveys to determine ED patient uptake (receipt) of COVID-19 and influenza vaccines. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with greater COVID-19 and influenza vaccine uptake in ED patients.
We will conduct a cluster-randomized, controlled trial (RCT) of implementation of our PROCOVAXED platforms in 5 high-volume, safety net hospital EDs, testing two hypotheses that implementation of PROCOVAXED platforms will be associated with increased acceptance and uptake of COVID-19 and influenza vaccines in ED USCARE patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Cluster Randomized Trial: Intervention arm is delivery of Covid vaccine messaging Non-intervention arm is usual care.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED|
|Estimated Study Start Date :||December 6, 2021|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Intervention Arm
Covid vaccine educational intervention
Other: Covid-19 vaccine education materials
videos and flyers containing Covid-19 vaccine educational information
No Intervention: Non-interventional Arm
- Covid-19 Vaccine uptake [ Time Frame: within one month of intervention ]participant update of Covid-19 vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142332
|Contact: Robin Kemball, MPHemail@example.com|
|Contact: Virginia Chanfirstname.lastname@example.org|
|United States, California|
|San Francisco General Hospital ICU|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Robert Rodriguez, MD||University of California, San Francisco|