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临床试验/NCT05836818
NCT05836818已完成不适用

PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

University of California, San Francisco16 个研究点 分布在 1 个国家目标入组 776 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
776
试验地点
16
主要终点
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

outcomes assessor will not know arm assignment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention

时间窗: 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.

次要结局

  • Vaccine Acceptance(during ED visit)
  • Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group(30 days post index ED visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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