Covid-19 Vaccine Clinical Trial
— PROCOVAXEDOfficial title:
PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED
Verified date | November 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Duke University, National Institute of Allergy and Infectious Diseases (NIAID), Thomas Jefferson University, University of Washington |
United States,
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 |
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