跳至主要内容
临床试验/NCT05142332
NCT05142332终止不适用

PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED

University of California, San Francisco14 个研究点 分布在 1 个国家目标入组 541 人开始时间: 2021年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
541
试验地点
14
主要终点
Covid-19 Vaccine Uptake: PROCOVAXED

研究概览

简要总结

The goal of this research is to increase COVID-19 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 COvid-19 VA(X)ccination in the Emergency Department - PROCOVAXED) that will address barriers to COVID-19 vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, controlled trial of PROCOVAXED platforms in six EDs to determine whether their implementation is associated with greater COVID-19 vaccine acceptance and uptake in ED Usual Source of Care Patients.

详细描述

The investigator's preliminary work research at 15 ED sites across the US indicates that ED Usual Source of Care patients have particular health care access barriers, needs, and perceptions about vaccines (vaccine hesitancy) that require specific review beyond traditional (non-ED user) community engagement techniques. To gain insight about messaging that effectively addresses these barriers, needs, and perceptions, the investigators will conduct one on one interviews and focus group meetings with ED Usual Source of Care Patients and community partners.

At five safety net EDs (Zuckerberg San Francisco General, Thomas Jefferson University Hospital [Philadelphia], Methodist Hospital [Philadelphia], Harborview Medical Center [Seattle], and Duke University Medical Center [Durham, NC], the investigators will conduct a cluster-randomized, controlled trial of implementation of PROCOVAXED platforms, with COVID-19 and influenza vaccine acceptance rates on post-intervention ED surveys as the primary outcomes. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with increased acceptance of COVID-19 vaccines in ED patients.

One month after subjects' index ED visit enrollment in our PROCOVAXED implementation trial, the investigators will conduct electronic health record review and phone follow-up surveys to determine ED patient uptake (receipt) of COVID-19 vaccines. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with greater COVID-19 vaccine uptake in ED patients.

The investigators will conduct a cluster-randomized, controlled trial (RCT) of implementation of our PROCOVAXED platforms in 5 high-volume, safety net hospital EDs, testing two hypotheses that implementation of PROCOVAXED platforms will be associated with increased acceptance and uptake of COVID-19 vaccines in ED Usual Source of Care 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)

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

  • Adults (>18 years of age) patients who are receiving care at participating Emergency Departments and have not yet received a COVID-19 vaccine (PROCOVAXED)

排除标准

  • major trauma patients
  • patients transferred from another hospital, chronic care facility, nursing home or hospice,
  • patients unable to participate in an interview because of intoxication, altered mental status or critical illness
  • incarcerated patients
  • patients on psychiatric holds
  • patients who have received a COVID-19 vaccine
  • under suspicion for acute COVID-19 illness

结局指标

主要结局

Covid-19 Vaccine Uptake: PROCOVAXED

时间窗: Within 30 days of intervention

Participation uptake of the COVID-19 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 28 to 30 days - We are asking patients if they received a COVID-19 vaccine since their index emergency department visit.

Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED

时间窗: Within 6 hours of intervention

Participant acceptance of the COVID-19 vaccine assessed by the question "Would you accept the COVID-19 vaccine in the emergency department today if your doctor or provider asked you to get it?" The response choices for this question are "Yes", "No", and "No, but I might consider getting it at some other time". This question will be asked once at the end of the Emergency Department visit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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