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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05142332
Acronym
PROCOVAXED
Enrollment
541
Registered
2021-12-02
Start date
2021-12-06
Completion date
2022-08-30
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 Vaccine, Vaccine Hesitancy

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.

Interventions

OTHERCovid-19 vaccine education materials

videos and flyers containing Covid-19 vaccine educational information

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXEDWithin 6 hours of interventionParticipant 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.
Covid-19 Vaccine Uptake: PROCOVAXEDWithin 30 days of interventionParticipation uptake of the COVID-19 vaccine 30 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 30 days - We are asking patients if they received a COVID-19 vaccine since their index emergency department visit.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Arm: PROCOVAXED
Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging) Covid-19 vaccine education materials: videos and flyers containing Covid-19 vaccine educational information
221
Non-interventional Arm: PROCOVAXED
Usual care
275
Total496

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyBecame ineligible (e.g. developed altered mental status)2012010
Overall StudyLeft ED3046126
Overall StudyPhysician Decision0021003
Overall StudyWithdrawal by Subject0120026

Baseline characteristics

CharacteristicTotalIntervention Arm: PROCOVAXEDNon-interventional Arm: PROCOVAXED
Age, Continuous39 years39 years39 years
Has a primary care clinic or physician
No
218 Participants101 Participants117 Participants
Has a primary care clinic or physician
Unsure
1 Participants1 Participants0 Participants
Has a primary care clinic or physician
Yes
277 Participants119 Participants158 Participants
Housing status
Housed
408 Participants172 Participants236 Participants
Housing status
Marginal
19 Participants10 Participants9 Participants
Housing status
No answer given
1 Participants1 Participants0 Participants
Housing status
Unhoused
68 Participants38 Participants30 Participants
Primary language
English
435 Participants196 Participants239 Participants
Primary language
Other
14 Participants3 Participants11 Participants
Primary language
Spanish
47 Participants22 Participants25 Participants
Race/Ethnicity, Customized
African American
193 Participants71 Participants122 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
18 Participants14 Participants4 Participants
Race/Ethnicity, Customized
Asian
12 Participants5 Participants7 Participants
Race/Ethnicity, Customized
Latinx
97 Participants50 Participants47 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
10 Participants4 Participants6 Participants
Race/Ethnicity, Customized
Other
48 Participants23 Participants25 Participants
Race/Ethnicity, Customized
White, non-Latinx
183 Participants85 Participants98 Participants
Region of Enrollment
United States
496 participants221 participants275 participants
Sex/Gender, Customized
Female
205 Participants86 Participants119 Participants
Sex/Gender, Customized
Male
289 Participants134 Participants155 Participants
Sex/Gender, Customized
Other
2 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2210 / 275
other
Total, other adverse events
0 / 2210 / 275
serious
Total, serious adverse events
0 / 2210 / 275

Outcome results

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.

Time frame: Within 6 hours of intervention

Population: Intent to treat

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Arm: PROCOVAXEDCovid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED57 Participants
Non-interventional Arm: PROCOVAXEDCovid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED33 Participants
p-value: <0.00195% CI: [4.5, 19.3]Regression, Logistic
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: 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 30 days - We are asking patients if they received a COVID-19 vaccine since their index emergency department visit.

Time frame: Within 30 days of intervention

Population: Intent to treat

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Arm: PROCOVAXEDCovid-19 Vaccine Uptake: PROCOVAXED44 Participants
Non-interventional Arm: PROCOVAXEDCovid-19 Vaccine Uptake: PROCOVAXED24 Participants
p-value: <0.00195% CI: [1.7, 14.1]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026