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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI166967-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Thomas Jefferson University | OTHER |
| University of Washington | OTHER |
| Baylor College of Medicine |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Question (Q) | Experimental | Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine |
|
| Messaging (M) | Experimental | Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine |
|
| Non intervention | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Question (Q) | Other | Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days post index ED visit |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Acceptance | Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups | during ED visit |
| Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Rodriguez, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital Emergency Department | San Francisco | California | 94110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38776635 | Derived | Rodriguez RM, Eucker SA, Rafique Z, Nichol G, Molina MF, Kean E, O'Laughlin KN, Bezek SK, Goicochea K, Ford JS, Morse D, White J, Arreguin MI, Shughart L, Chavez CL, Glidden DV, Rising KL. Promotion of Influenza Vaccination in the Emergency Department. NEJM Evid. 2024 Apr;3(4):EVIDoa2300197. doi: 10.1056/EVIDoa2300197. Epub 2024 Mar 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Non Intervention | Usual care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Messaging (M) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Count of Participants | Participants | 30 days post index ED visit |
|
Up to 30 days post ED index visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Rodriguez | University of California San Francisco | 925-457-2145 | robert.rodriguez@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2022 | Nov 21, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2023 | May 1, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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.
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outcomes assessor will not know arm assignment
| Messaging (M) | Other | Flu vaccine educational materials -videos and flyers containing flu vaccine educational information |
|
Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:
|
| 30 days post index ED visit |
| 30 days post index ED visit |
| University of California San Francisco Parnassus |
| San Francisco |
| California |
| 94143 |
| United States |
| Duke University Hospital | Durham | North Carolina | 27708 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | United States |
| Jefferson Methodist Hospital | Philadelphia | Pennsylvania | 19148 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Washington-Harborview Emergency Department | Seattle | Washington | 98104 | United States |
| Later found to be previously vaccinated |
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| Pregnancy |
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| Allergic to vaccines |
|
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 |
| BG002 | Non Intervention | Usual care |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants could choose multiple answers and thus may be counted more than once | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Non Intervention | Usual care, no intervention given. Control group |
|
|
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| Secondary | Vaccine Acceptance | Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups | Posted | Count of Participants | Participants | during ED visit |
|
|
|
| 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:
| Posted | Count of Participants | Participants | 30 days post index ED visit |
|
|
|
| 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:
| Posted | Count of Participants | Participants | 30 days post index ED visit |
|
|
|
| 0 |
| 244 |
| 0 |
| 244 |
| 0 |
| 244 |
| EG001 | 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 | 1 | 210 | 0 | 210 | 0 | 210 |
| EG002 | Non Intervention | Usual care | 2 | 313 | 0 | 313 | 0 | 313 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |