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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05142332
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : June 2, 2022
Sponsor:
Collaborators:
Duke University
Thomas Jefferson University
University of Washington
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
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, the investigators 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. The investigators 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.

Condition or disease Intervention/treatment Phase
Covid-19 Vaccine Vaccine Hesitancy Other: Covid-19 vaccine education materials Not Applicable

Detailed Description:

The investigator's 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, the investigators 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], the investigators 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, the investigators 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.

The investigators 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 Usual Source of Care Patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1290 participants
Allocation: Randomized
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: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Arm
Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging)
 Other: Covid-19 vaccine education materials
videos and flyers containing Covid-19 vaccine educational information
No Intervention: Non-interventional Arm
Usual care


Outcome Measures
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Primary Outcome Measures :
  1. Covid-19 vaccine acceptance in the emergency department [ Time Frame: Within 6 hours of intervention ]

    Participant acceptance of the COVID-19 vaccine assessed by the question "Would you accept the COVID-19 vaccine in the emergency department today if your doctor or provider asked you to get it?" The response choices for this question are "Yes", "No", and "No, but I might consider getting it at some other time".

    This question will be asked once at the end of the Emergency Department visit.


  2. Covid-19 vaccine uptake [ Time Frame: Within 32 days of intervention ]

    Participation uptake of the COVID-19 vaccine 32 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:

    1. Receipt in emergency department during index (enrollment) visit
    2. Electronic health record review 30 days after index visit
    3. Follow up phone call to participant at 28 to 32 days - We are asking patients if they received a COVID-19 vaccine since their index emergency department visit.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (>18 years of age) patients who are receiving care at participating Emergency Departments 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
  • under suspicion for acute COVID-19 illness
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Robin Kemball, MPH 415-509-9842 robin.kemball@ucsf.edu
Contact: Virginia Chan virginia.chan@ucsf.edu

Locations
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United States, California
San Francisco General Hospital Emergency Department Recruiting
San Francisco, California, United States, 94110
Contact: robert m rodriguez, md    415-206-5875      
Principal Investigator: robert m rodriguez, md         
University of California, San Francisco - Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Robert Rodriguez, MD       robert.rodriguez@ucsf.edu   
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27708
Contact: Stephanie Eucker, MD       stephanie.eucker@duke.edu   
Contact: Alena Pauley       alena.pauley@duke.edu   
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Anna Marie Chang, MD       annamarie.chang@jefferson.edu   
Jefferson Torresdale Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Anna Marie Chang, MD       annamarie.chang@jefferson.edu   
Jefferson Methodist Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19148
Contact: Anna Marie Chang, MD       annamarie.chang@jefferson.edu   
United States, Washington
University of Washington-Harborview Emergency Department Recruiting
Seattle, Washington, United States, 98104
Contact: Graham Nichol, MD       nichol@uw.edu   
Contact: Dana Morse, BSN       dmorse2@uw.edu   
Sponsors and Collaborators
University of California, San Francisco
Duke University
Thomas Jefferson University
University of Washington
Investigators
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Principal Investigator: Robert Rodriguez, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05142332    
Other Study ID Numbers: 21-34004
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Emergencies
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes