Clinical trial NCT05142332: PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED
Official title: PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid-19 Vaccine
Vaccine Hesitancy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Duke University
name: Thomas Jefferson University
name: University of Washington
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-12-02
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parent Cluster Randomized Trial: Intervention arm is delivery of Covid vaccine messaging Non-intervention arm is usual care. (2 arms)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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.

Eligibility 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 (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

Primary outcomes:
measure: Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED
timeFrame: Within 6 hours of intervention
measure: Covid-19 Vaccine Uptake: PROCOVAXED
timeFrame: Within 30 days of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital Emergency Department
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco - Parnassus
state: California
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Torresdale Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Methodist Hospital
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington-Harborview Emergency Department
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: Robert Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez RM, O'Laughlin K, Eucker SA, Chang AM, Rising KL, Nichol G, Pauley A, Kanzaria H, Gentsch AT, Li C, Duber H, Butler J, Eswaran V, Glidden D. PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial. Trials. 2022 Apr 21;23(1):332. doi: 10.1186/s13063-022-06285-x.