An interventional study of Question (Q) and Messaging (M) in Influenza Vaccination, sponsored by University of California, San Francisco. Completed at 8 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 776 is above the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine
Other: Question (Q)
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine
Other: Question (Q) · Other: Messaging (M)
Usual care
Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
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
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
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
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
| Milestone | Question (Q) | Messaging (M) | Non Intervention |
|---|---|---|---|
| Started | 245 | 214 | 317 |
| Completed | 244 | 210 | 313 |
| Not completed | 1 | 4 | 4 |
| Withdrew: Physician decision | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Later found to be previously vaccinated | 0 | 1 | 3 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| Withdrew: Allergic to vaccines | 0 | 1 | 0 |
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.
| Participants | Messaging (M) | Non Intervention |
|---|---|---|
| Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention | 86 | 47 |
Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups
| Participants | Messaging (M) | Question (Q) |
|---|---|---|
| Vaccine Acceptance | 103 | 110 |
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.
| Participants | Question (Q) | Non Intervention |
|---|---|---|
| Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group | 78 | 47 |
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.
| Participants | Messaging (M) | Question (Q) |
|---|---|---|
| Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q | 86 | 78 |
Collected over Up to 30 days post ED index visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Question (Q) | 0/244 (0%) | 0/244 (0%) | 0/244 (0%) |
| Messaging (M) | 1/210 (0.5%) | 0/210 (0%) | 0/210 (0%) |
| Non Intervention | 2/313 (0.6%) | 0/313 (0%) | 0/313 (0%) |
| Age, Continuous(years) | Question (Q) | Messaging (M) | Non Intervention | Total |
|---|---|---|---|---|
| Median | 49 (32 to 61) | 47 (33 to 59) | 44 (32 to 58) | 46 (32 to 59) |
| Sex/Gender, Customized(Participants) | Question (Q) | Messaging (M) | Non Intervention | Total |
|---|---|---|---|---|
| Female | 104 | 99 | 150 | 353 |
| Male | 136 | 109 | 161 | 406 |
| Other | 4 | 2 | 2 | 8 |
| Race/Ethnicity, Customized(Participants) | Question (Q) | Messaging (M) | Non Intervention | Total |
|---|---|---|---|---|
| African American | 81 | 73 | 120 | 274 |
| American Indian/Alaska Native | 3 | 6 | 12 | 21 |
| Asian | 8 | 8 | 17 | 33 |
| Latinx | 50 | 52 | 56 | 158 |
| Native Hawaiian/Pacific Islander | 1 | 4 | 2 | 7 |
| Middle Eastern | 2 | 1 | 1 | 4 |
| White (Non-Latino) | 96 | 78 | 112 | 286 |
| Other | 20 | 14 | 24 | 58 |
| Region of Enrollment(Participants) | Question (Q) | Messaging (M) | Non Intervention | Total |
|---|---|---|---|---|
| United States | 244 | 210 | 313 | 767 |
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University of California, San Francisco