PROmotion of COvid-19 VA(X)Ccination in the Emergency Department – PROCOVAXED

Overview

The goal of this research is to increase COVID-19 and influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal we will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of COvid-19 VA(X)ccination in the Emergency Department – PROCOVAXED) that will address barriers to COVID-19 and influenza vaccination, especially vaccine hesitancy. We will then conduct a cluster-randomized, controlled trial of PROCOVAXED platforms in six EDs to determine whether their implementation is associated with greater COVID-19 and influenza vaccine acceptance and uptake in ED Usual Source of Care Patients.

Full Title of Study: “PROmotion of COvid-19 VA(X)Ccination in the Emergency Department – PROCOVAXED”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2024

Detailed Description

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.

Interventions

  • Other: Covid-19 vaccine education materials
    • videos and flyers containing Covid-19 vaccine educational information

Arms, Groups and Cohorts

  • Experimental: Intervention Arm
    • Covid vaccine educational intervention
  • No Intervention: Non-interventional Arm
    • Usual care

Clinical Trial Outcome Measures

Primary Measures

  • Covid-19 Vaccine uptake
    • Time Frame: within one month of intervention
    • participant update of Covid-19 vaccine

Participating in This Clinical Trial

Inclusion Criteria

  • Adults (>18 years of age) patients who have received care at the participating sites Emergency Department and have not yet received a COVID-19 vaccine Exclusion Criteria:

  • major trauma patients – patients transferred from another hospital, chronic care facility, nursing home or hospice, – patients unable to participate in an interview because of intoxication, altered mental status or critical illness – incarcerated patients – patients on psychiatric holds – patients who have received a COVID-19 vaccine

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Rodriguez, MD, Principal Investigator, University of California, San Francisco
  • Overall Contact(s)
    • Robin Kemball, MPH, 415-509-9842, robin.kemball@ucsf.edu

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