The Feasibility of Pertussis Immunization in a Canadian Emergency Department
2018年1月24日 更新者：University of Prince Edward Island
Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine to patients presenting to the emergency department.
Rates of vaccination as well as effects on department efficiency will be measured.
研究概览
详细说明
This study is a prospective randomized, controlled trial of two strategies to provide patients with the pertussis vaccine.
Eligible adult patients with be offered pertussis vaccination in the Emergency Department vs. a referral to Public Health for pertussis vaccination.
The effect of both strategies on triage time as well as measure of emergency department efficiency including length of stay, time to physician and left without being seen rates will be compared.
At a four-month follow up, rates of pertussis vaccination will be measured.
研究类型
介入性
注册 (实际的)
644
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Prince Edward Island
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Charlottetown、Prince Edward Island、加拿大、PO Box 6600
- Queen Elizabeth Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults age 18 and above
- Have not received Tdap vaccine as an adult (age 18 and above) or have not received Tdap vaccine within 10 years, or unsure of vaccination status
Exclusion Criteria:
- Acute significant illness (Canadian Triage and Acuity Scale = 1)
- Deemed "in too much distress" by triage nurse
- Acute Febrile illness
- Allergy to vaccine or vaccine components
- Pts presenting for wound care (are normally given the vaccine as part of wound care)
- Pregnancy < 26 weeks
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Emergency Department vaccination group
Pertussis (Tdap) vaccine offered/administered in the Emergency Department
|
Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
其他名称：
|
|
实验性的：Public Health referral group
Public Health referral for Pertussis (Tdap) vaccine administration offered
|
Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of immunization
大体时间：One day
|
Rate of patients receiving Tdap vaccine
|
One day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of Stay
大体时间：One day
|
Length of Stay (mins, secs) for all patients presenting to the emergency.
department on study days.
|
One day
|
|
Left with out being seen rate
大体时间：One day
|
Rate of patients leaving without being seen by a physician on study days.
|
One day
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|
Time to physician
大体时间：One day
|
Time to be seen by emergency physician after triage (mins, secs) on study days.
|
One day
|
|
Patient refusals
大体时间：One day
|
Reasons for patient vaccination refusal
|
One day
|
|
Nursing satisfaction
大体时间：One day
|
Five statements rated on 5 point likert scale (strongly disagree (1) to strongly agree (5)).
The immunization strategy significantly increased my workload; patient care was negatively affected by the immunization strategy; I was unable to provide the standard of care because of the immunization strategy; patient flow within the department was negatively affected by the immunization strategy; the ED should implement the immunization strategy
|
One day
|
|
Additional vaccine received
大体时间：One day
|
Additional vaccines administered in the Public Health referral arm
|
One day
|
|
Triage time
大体时间：One day
|
Time (in seconds) required to triage eligible patients in the emergency department
|
One day
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Aaron Sibley, MD、University of Prince Edward Island
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月10日
初级完成 (实际的)
2017年12月20日
研究完成 (实际的)
2017年12月20日
研究注册日期
首次提交
2017年9月25日
首先提交符合 QC 标准的
2017年10月2日
首次发布 (实际的)
2017年10月6日
研究记录更新
最后更新发布 (实际的)
2018年1月26日
上次提交的符合 QC 标准的更新
2018年1月24日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Tdap的临床试验
-
Sanofi Pasteur, a Sanofi Company完全的破伤风免疫（健康志愿者） | 白喉免疫（健康志愿者） | 百日咳免疫（健康志愿者）加拿大
-
Centre Hospitalier Universitaire Saint Pierre完全的
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Vanderbilt UniversityDuke University; Centers for Disease Control and Prevention完全的
-
Institute of Arthritis ResearchLouisiana State University Health Sciences Center in New Orleans; Brigham Young University尚未招聘