Covid-19 Vaccine, Vaccine Hesitancy
Conditions
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
videos and flyers containing Covid-19 vaccine educational information
Sponsors
Study design
Intervention model description
Parent Cluster Randomized Trial: Intervention arm is delivery of Covid vaccine messaging Non-intervention arm is usual care. (2 arms)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED | Within 6 hours of intervention | 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. |
| Covid-19 Vaccine Uptake: PROCOVAXED | Within 30 days of intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 496 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Became ineligible (e.g. developed altered mental status) | 2 | 0 | 1 | 2 | 0 | 1 | 0 |
| Overall Study | Left ED | 3 | 0 | 4 | 6 | 1 | 2 | 6 |
| Overall Study | Physician Decision | 0 | 0 | 2 | 1 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 | 0 | 2 | 6 |
Baseline characteristics
| Characteristic | Total | Intervention Arm: PROCOVAXED | Non-interventional Arm: PROCOVAXED |
|---|---|---|---|
| Age, Continuous | 39 years | 39 years | 39 years |
| Has a primary care clinic or physician No | 218 Participants | 101 Participants | 117 Participants |
| Has a primary care clinic or physician Unsure | 1 Participants | 1 Participants | 0 Participants |
| Has a primary care clinic or physician Yes | 277 Participants | 119 Participants | 158 Participants |
| Housing status Housed | 408 Participants | 172 Participants | 236 Participants |
| Housing status Marginal | 19 Participants | 10 Participants | 9 Participants |
| Housing status No answer given | 1 Participants | 1 Participants | 0 Participants |
| Housing status Unhoused | 68 Participants | 38 Participants | 30 Participants |
| Primary language English | 435 Participants | 196 Participants | 239 Participants |
| Primary language Other | 14 Participants | 3 Participants | 11 Participants |
| Primary language Spanish | 47 Participants | 22 Participants | 25 Participants |
| Race/Ethnicity, Customized African American | 193 Participants | 71 Participants | 122 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 18 Participants | 14 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Latinx | 97 Participants | 50 Participants | 47 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 10 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 48 Participants | 23 Participants | 25 Participants |
| Race/Ethnicity, Customized White, non-Latinx | 183 Participants | 85 Participants | 98 Participants |
| Region of Enrollment United States | 496 participants | 221 participants | 275 participants |
| Sex/Gender, Customized Female | 205 Participants | 86 Participants | 119 Participants |
| Sex/Gender, Customized Male | 289 Participants | 134 Participants | 155 Participants |
| Sex/Gender, Customized Other | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 221 | 0 / 275 |
| other Total, other adverse events | 0 / 221 | 0 / 275 |
| serious Total, serious adverse events | 0 / 221 | 0 / 275 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm: PROCOVAXED | Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED | 57 Participants |
| Non-interventional Arm: PROCOVAXED | Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED | 33 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm: PROCOVAXED | Covid-19 Vaccine Uptake: PROCOVAXED | 44 Participants |
| Non-interventional Arm: PROCOVAXED | Covid-19 Vaccine Uptake: PROCOVAXED | 24 Participants |