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

Covid-19 Vaccine Clinical Trial

— PROCOVAXED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05142332
• Other study ID #: 21-34004
• Secondary ID: R01AI166967-01
• Status: Terminated
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to increase COVID-19 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 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 vaccine acceptance and uptake in ED Usual Source of Care Patients.

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 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 vaccines. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with greater COVID-19 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 vaccines in ED Usual Source of Care Patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 541
• Est. completion date: August 30, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (PROCOVAXED)

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

Related Conditions & MeSH terms

• COVID-19
• Covid-19 Vaccine
• Emergencies
• Vaccine Hesitancy

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina
United States	Jefferson Methodist Hospital	Philadelphia	Pennsylvania
United States	Jefferson Torresdale Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	San Francisco General Hospital Emergency Department	San Francisco	California
United States	University of California, San Francisco - Parnassus	San Francisco	California
United States	University of Washington-Harborview Emergency Department	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Duke University, National Institute of Allergy and Infectious Diseases (NIAID), Thomas Jefferson University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED	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.	Within 6 hours of intervention
Primary	Covid-19 Vaccine Uptake: PROCOVAXED	Participation uptake of the COVID-19 vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways: Receipt in emergency department during index (enrollment) visit; Electronic health record review 30 days after index visit; Follow up phone call to participant at 28 to 30 days - We are asking patients if they received a COVID-19 vaccine since their index emergency department visit.	Within 30 days of intervention