Trial Outcomes & Findings for PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED (NCT NCT05142332)
NCT ID: NCT05142332
Last Updated: 2023-12-13
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
541 participants
Primary outcome timeframe
Within 6 hours of intervention
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
Zuckerberg San Francisco Hospital
First Condition: Control
|
University of California San Francisco Hospital -Parnassus
First Condition: Control
|
Duke University Hospital
First condition: Intervention
|
Thomas Jefferson University Hospital
First Condition: Control
|
Jefferson Torresdale Hospital
First Condition: Intervention
|
Jefferson Methodist Hospital
First Condition: Intervention
|
University of Washington-Harborview Emergency Department
First condition: Control
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
166
|
27
|
110
|
97
|
12
|
12
|
117
|
|
Overall Study
Received PROCOVAXED Intervention
|
82
|
8
|
49
|
27
|
2
|
3
|
50
|
|
Overall Study
C C Control
|
79
|
18
|
52
|
61
|
9
|
4
|
52
|
|
Overall Study
COMPLETED
|
161
|
26
|
101
|
88
|
11
|
7
|
102
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
9
|
9
|
1
|
5
|
15
|
Reasons for withdrawal
| Measure |
Zuckerberg San Francisco Hospital
First Condition: Control
|
University of California San Francisco Hospital -Parnassus
First Condition: Control
|
Duke University Hospital
First condition: Intervention
|
Thomas Jefferson University Hospital
First Condition: Control
|
Jefferson Torresdale Hospital
First Condition: Intervention
|
Jefferson Methodist Hospital
First Condition: Intervention
|
University of Washington-Harborview Emergency Department
First condition: Control
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
0
|
2
|
6
|
|
Overall Study
Left ED
|
3
|
0
|
4
|
6
|
1
|
2
|
6
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
1
|
0
|
0
|
3
|
|
Overall Study
Became ineligible (e.g. developed altered mental status)
|
2
|
0
|
1
|
2
|
0
|
1
|
0
|
Baseline Characteristics
PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED
Baseline characteristics by cohort
| Measure |
Intervention Arm: PROCOVAXED
n=221 Participants
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
|
Non-interventional Arm: PROCOVAXED
n=275 Participants
Usual care
|
Total
n=496 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
39 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
86 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
134 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
71 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latinx
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Latinx
|
85 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
221 participants
n=5 Participants
|
275 participants
n=7 Participants
|
496 participants
n=5 Participants
|
|
Has a primary care clinic or physician
Yes
|
119 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Has a primary care clinic or physician
No
|
101 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Has a primary care clinic or physician
Unsure
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary language
English
|
196 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Primary language
Spanish
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Primary language
Other
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Housing status
Housed
|
172 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Housing status
Marginal
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Housing status
Unhoused
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Housing status
No answer given
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 6 hours of interventionPopulation: Intent to treat
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.
Outcome measures
| Measure |
Intervention Arm: PROCOVAXED
n=221 Participants
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
|
Non-interventional Arm: PROCOVAXED
n=275 Participants
Usual care
|
|---|---|---|
|
Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED
|
57 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of interventionPopulation: Intent to treat
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.
Outcome measures
| Measure |
Intervention Arm: PROCOVAXED
n=221 Participants
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
|
Non-interventional Arm: PROCOVAXED
n=275 Participants
Usual care
|
|---|---|---|
|
Covid-19 Vaccine Uptake: PROCOVAXED
|
44 Participants
|
24 Participants
|
Adverse Events
Intervention Arm: PROCOVAXED
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-interventional Arm: PROCOVAXED
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Rodriguez
University of California San Francsico
Phone: (628) 206-5875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place