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

NCT ID: NCT05142332

Last Updated: 2023-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2022-08-30

Brief Summary

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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

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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.

Conditions

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Covid-19 Vaccine Vaccine Hesitancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parent Cluster Randomized Trial: Intervention arm is delivery of Covid vaccine messaging Non-intervention arm is usual care. (2 arms)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Arm: PROCOVAXED

Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging)

Group Type EXPERIMENTAL

Covid-19 vaccine education materials

Intervention Type OTHER

videos and flyers containing Covid-19 vaccine educational information

Non-interventional Arm: PROCOVAXED

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Covid-19 vaccine education materials

videos and flyers containing Covid-19 vaccine educational information

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco General Hospital Emergency Department

San Francisco, California, United States

Site Status

University of California, San Francisco - Parnassus

San Francisco, California, United States

Site Status

Duke University Hospital

Durham, North Carolina, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Washington-Harborview Emergency Department

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Rodriguez RM, Nichol G, Eucker SA, Chang AM, O'Laughlin KN, Pauley A, Rising KL, Eswaran V, Morse D, Li C, Patel A, Duber HC, Arreguin M, Shughart L, Glidden D; PROCOVAXED Study Network. Effect of COVID-19 Vaccine Messaging Platforms in Emergency Departments on Vaccine Acceptance and Uptake: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Feb 1;183(2):115-123. doi: 10.1001/jamainternmed.2022.5909.

Reference Type DERIVED
PMID: 36574256 (View on PubMed)

Gentsch AT, Butler J, O'Laughlin K, Eucker SA, Chang A, Duber H, Geyer RE, Guth A, Kanzaria HK, Pauley A, Rising KL, Chavez CL, Tupetz A, Rodriguez RM. Perspectives of COVID-19 vaccine-hesitant emergency department patients to inform messaging platforms to promote vaccine uptake. Acad Emerg Med. 2023 Jan;30(1):32-39. doi: 10.1111/acem.14620. Epub 2022 Nov 22.

Reference Type DERIVED
PMID: 36310395 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35449064 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01AI166967-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-34004

Identifier Type: -

Identifier Source: org_study_id