Influenza Vaccination
Conditions
Brief summary
The goal of this research is to increase influenza 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 FLU VA(X)ccination in the Emergency Department - PROFLUVAXED) that will address barriers to flu vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, controlled trial of PROFLUVAXED platforms in six EDs to determine whether their implementation is associated with greater flu vaccine acceptance and uptake in ED Usual Source of Care Patients.
Detailed description
Specific Aim I: To determine whether implementation of influenza vaccine trusted messaging platforms is associated with increased influenza vaccine uptake in unvaccinated ED patients. At six EDs (Zuckerberg San Francisco General, UCSF Parnassus Medical Center \[San Francisco, CA\], Thomas Jefferson University Hospital \[Philadelphia, PA\], Ben Taub Hospital \[Houston, TX\], Harborview Medical Center \[Seattle, WA\], and Duke University Medical Center \[Durham, NC\]), investigators will conduct a cluster-randomized controlled trial of implementation of PROFLUVAXED trusted messaging platforms, with influenza vaccine uptake in the ED as the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine uptake in unvaccinated ED patients. Specific Aim II: To determine whether implementation of influenza vaccine trusted messaging platforms in EDs is associated with increased influenza vaccine acceptance in unvaccinated ED patients. For this specific aim influenza vaccine acceptance in the ED assessed via ED survey will be the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine acceptance in unvaccinated ED patients. Specific Aim III: To determine whether implementation of a protocol in which ED patients are asked whether they will accept an influenza vaccine in the ED (and notifying ED providers when they say they will accept it) is associated with increased influenza vaccine uptake in unvaccinated ED patients. Hypothesis: Implementation of an ED protocol in which patients are asked whether they will accept an influenza vaccine (and notifying ED providers when they say they will accept it) will be associated with increased influenza vaccine uptake in unvaccinated ED patients.
Interventions
OTHERQuestion (Q)
Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
OTHERMessaging (M)
Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Sponsors
Duke University
Thomas Jefferson University
University of Washington
Baylor College of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
outcomes assessor will not know arm assignment
Intervention model description
A three-arm cluster randomized control trial to determine the effect of vaccine messaging and a question about acceptance, a question about acceptance without messaging, and standard care affect vaccine uptake in the ED.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults 2. Presenting to ED 3. Not already vaccinated for influenza in the current year 4. Able to provide informed consent 5. Fluent in English or Spanish 6. Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip
Exclusion criteria
1. Age \< 18 years 2. Major trauma such that it will preclude survey 3. Inability to participate in a survey because of intoxication, altered mental status, or critical illness 4. Incarceration 5. Psychiatric hold 6. We will also exclude patients who state that they have already received an influenza vaccine and patients who are in the ED for suspected acute Covid or influenza illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Acceptance | during ED visit | Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups |
| Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 244 |
| 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 | 210 |
| Non Intervention Usual care | 313 |
| Total | 767 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Allergic to vaccines | 0 | 1 | 0 |
| Overall Study | Later found to be previously vaccinated | 0 | 1 | 3 |
| Overall Study | Physician Decision | 1 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Question (Q) | Total | Non Intervention | Messaging (M) |
|---|---|---|---|---|
| Age, Continuous | 49 years | 46 years | 44 years | 47 years |
| Race/Ethnicity, Customized African American | 81 Participants | 274 Participants | 120 Participants | 73 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 3 Participants | 21 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 33 Participants | 17 Participants | 8 Participants |
| Race/Ethnicity, Customized Latinx | 50 Participants | 158 Participants | 56 Participants | 52 Participants |
| Race/Ethnicity, Customized Middle Eastern | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 58 Participants | 24 Participants | 14 Participants |
| Race/Ethnicity, Customized White (Non-Latino) | 96 Participants | 286 Participants | 112 Participants | 78 Participants |
| Region of Enrollment United States | 244 Participants | 767 Participants | 313 Participants | 210 Participants |
| Sex/Gender, Customized Female | 104 Participants | 353 Participants | 150 Participants | 99 Participants |
| Sex/Gender, Customized Male | 136 Participants | 406 Participants | 161 Participants | 109 Participants |
| Sex/Gender, Customized Other | 4 Participants | 8 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 244 | 1 / 210 | 2 / 313 |
| other Total, other adverse events | 0 / 244 | 0 / 210 | 0 / 313 |
| serious Total, serious adverse events | 0 / 244 | 0 / 210 | 0 / 313 |
Outcome results
Primary
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention
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.
Time frame: 30 days post index ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messaging (M) | Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention | 86 Participants |
| Non Intervention | Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention | 47 Participants |
Comparison: Adjusted difference 25.1 percentage pointsp-value: <0.000195% CI: [17, 33.2]Regression, Logistic
Secondary
Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group
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.
Time frame: 30 days post index ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messaging (M) | Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group | 78 Participants |
| Non Intervention | Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group | 47 Participants |
Secondary
Vaccine Acceptance
Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups
Time frame: during ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messaging (M) | Vaccine Acceptance | 103 Participants |
| Non Intervention | Vaccine Acceptance | 110 Participants |
Other Pre-specified
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q
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.
Time frame: 30 days post index ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messaging (M) | Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q | 86 Participants |
| Non Intervention | Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q | 78 Participants |