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Trial Outcomes & Findings for PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED (NCT NCT05836818)

NCT ID: NCT05836818

Last Updated: 2024-05-31

Results Overview

Participant uptake of the influenza 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 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

776 participants

Primary outcome timeframe

30 days post index ED visit

Results posted on

2024-05-31

Participant Flow

Unit of analysis: Recruitment days across all sites

Participant milestones

Participant milestones
Measure
Question (Q)
Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
Messaging (M)
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
Usual care
Overall Study
STARTED
245 270
214 270
317 270
Overall Study
COMPLETED
244 270
210 270
313 270
Overall Study
NOT COMPLETED
1 0
4 0
4 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Question (Q)
Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
Messaging (M)
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
Usual care
Overall Study
Physician Decision
1
1
0
Overall Study
Withdrawal by Subject
0
0
1
Overall Study
Later found to be previously vaccinated
0
1
3
Overall Study
Pregnancy
0
1
0
Overall Study
Allergic to vaccines
0
1
0

Baseline Characteristics

PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Question (Q)
n=244 Participants
Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
Messaging (M)
n=210 Participants
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
n=313 Participants
Usual care
Total
n=767 Participants
Total of all reporting groups
Age, Continuous
49 years
n=5 Participants
47 years
n=7 Participants
44 years
n=5 Participants
46 years
n=4 Participants
Sex/Gender, Customized
Female
104 Participants
n=5 Participants
99 Participants
n=7 Participants
150 Participants
n=5 Participants
353 Participants
n=4 Participants
Sex/Gender, Customized
Male
136 Participants
n=5 Participants
109 Participants
n=7 Participants
161 Participants
n=5 Participants
406 Participants
n=4 Participants
Sex/Gender, Customized
Other
4 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
8 Participants
n=4 Participants
Race/Ethnicity, Customized
African American
81 Participants
n=5 Participants
73 Participants
n=7 Participants
120 Participants
n=5 Participants
274 Participants
n=4 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
3 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
21 Participants
n=4 Participants
Race/Ethnicity, Customized
Asian
8 Participants
n=5 Participants
8 Participants
n=7 Participants
17 Participants
n=5 Participants
33 Participants
n=4 Participants
Race/Ethnicity, Customized
Latinx
50 Participants
n=5 Participants
52 Participants
n=7 Participants
56 Participants
n=5 Participants
158 Participants
n=4 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
1 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
7 Participants
n=4 Participants
Race/Ethnicity, Customized
Middle Eastern
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
Race/Ethnicity, Customized
White (Non-Latino)
96 Participants
n=5 Participants
78 Participants
n=7 Participants
112 Participants
n=5 Participants
286 Participants
n=4 Participants
Race/Ethnicity, Customized
Other
20 Participants
n=5 Participants
14 Participants
n=7 Participants
24 Participants
n=5 Participants
58 Participants
n=4 Participants
Region of Enrollment
United States
244 Participants
n=5 Participants
210 Participants
n=7 Participants
313 Participants
n=5 Participants
767 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 30 days post index ED visit

Participant uptake of the influenza 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 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.

Outcome measures

Outcome measures
Measure
Messaging (M)
n=210 Participants
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
n=313 Participants
Usual care, no intervention given. Control group
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention
86 Participants
47 Participants

SECONDARY outcome

Timeframe: during ED visit

Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups

Outcome measures

Outcome measures
Measure
Messaging (M)
n=210 Participants
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
n=244 Participants
Usual care, no intervention given. Control group
Vaccine Acceptance
103 Participants
110 Participants

SECONDARY outcome

Timeframe: 30 days post index ED visit

Participant uptake of the influenza 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 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.

Outcome measures

Outcome measures
Measure
Messaging (M)
n=244 Participants
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
n=313 Participants
Usual care, no intervention given. Control group
Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group
78 Participants
47 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days post index ED visit

Participant uptake of the influenza 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 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.

Outcome measures

Outcome measures
Measure
Messaging (M)
n=210 Participants
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Question (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine Messaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Non Intervention
n=244 Participants
Usual care, no intervention given. Control group
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q
86 Participants
78 Participants

Adverse Events

Question (Q)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Messaging (M)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Non Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 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 Francisco

Phone: 925-457-2145

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place