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PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED (PROFLUVAXED)

Primary Purpose

Influenza Vaccination

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Question (Q)
Messaging (M)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults Presenting to ED Not already vaccinated for influenza in the current year Able to provide informed consent Fluent in English or Spanish Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip Exclusion Criteria: Age < 18 years Major trauma such that it will preclude survey Inability to participate in a survey because of intoxication, altered mental status, or critical illness Incarceration Psychiatric hold 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.

Sites / Locations

  • San Francisco General Hospital Emergency Department
  • University of California San Francisco Parnassus
  • Duke University Hospital
  • Thomas Jefferson University Hospital
  • Jefferson Torresdale Hospital
  • Jefferson Methodist Hospital
  • Baylor College of Medicine
  • University of Washington-Harborview Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Question (Q)

Messaging (M)

Non intervention

Arm Description

Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine

Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine

Usual care

Outcomes

Primary Outcome Measures

Influenza vaccine uptake in the emergency department
Vaccine uptake measured by medical record review on the day following ED visit
Comparative influenza vaccine uptake in the emergency department
Vaccine uptake in messaging versus question arms measured by medical record review on the day following ED visit

Secondary Outcome Measures

Influenza vaccine uptake in the emergency department
Participation uptake of the influenza vaccine 32 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways: Receipt in emergency department during index (enrollment) visit Electronic health record review 30 days after index visit Follow up phone call to participant at 28 to 32 days - We are asking patients if they received a flu vaccine since their index emergency department visit.

Full Information

First Posted
April 19, 2023
Last Updated
May 2, 2023
Sponsor
University of California, San Francisco
Collaborators
Duke University, Thomas Jefferson University, University of Washington, Baylor College of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05836818
Brief Title
PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
Acronym
PROFLUVAXED
Official Title
PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Duke University, Thomas Jefferson University, University of Washington, Baylor College of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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]), we 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
outcomes assessor will not know arm assignment
Allocation
Randomized
Enrollment
767 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Question (Q)
Arm Type
Experimental
Arm Description
Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine
Arm Title
Messaging (M)
Arm Type
Experimental
Arm Description
Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine
Arm Title
Non intervention
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Question (Q)
Intervention Description
Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
Intervention Type
Other
Intervention Name(s)
Messaging (M)
Intervention Description
Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
Primary Outcome Measure Information:
Title
Influenza vaccine uptake in the emergency department
Description
Vaccine uptake measured by medical record review on the day following ED visit
Time Frame
1 day post index ED visit
Title
Comparative influenza vaccine uptake in the emergency department
Description
Vaccine uptake in messaging versus question arms measured by medical record review on the day following ED visit
Time Frame
1 day post index ED visit
Secondary Outcome Measure Information:
Title
Influenza vaccine uptake in the emergency department
Description
Participation uptake of the influenza vaccine 32 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways: Receipt in emergency department during index (enrollment) visit Electronic health record review 30 days after index visit Follow up phone call to participant at 28 to 32 days - We are asking patients if they received a flu vaccine since their index emergency department visit.
Time Frame
Within 32 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults Presenting to ED Not already vaccinated for influenza in the current year Able to provide informed consent Fluent in English or Spanish Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip Exclusion Criteria: Age < 18 years Major trauma such that it will preclude survey Inability to participate in a survey because of intoxication, altered mental status, or critical illness Incarceration Psychiatric hold 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rodriguez, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital Emergency Department
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of California San Francisco Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Jefferson Torresdale Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Jefferson Methodist Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington-Harborview Emergency Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

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