Communication Regarding Organ and Tissue Donation in Intensive Care (COMFORT)
2017年10月3日 更新者：NSW Organ and Tissue Donation Service
Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
The overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices change rates of consent for donation, and other family-based outcomes.
研究概览
研究类型
介入性
注册 (实际的)
417
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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New South Wales
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New Lambton Heights、New South Wales、澳大利亚、2305
- John Hunter Hospital
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Sydney、New South Wales、澳大利亚、2145
- The Children's Hospital at Westmead
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Sydney、New South Wales、澳大利亚、2065
- Royal North Shore Hospital
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Sydney、New South Wales、澳大利亚、2010
- St Vincent's Hospital
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Sydney、New South Wales、澳大利亚、2031
- Prince of Wales Hospital
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Sydney、New South Wales、澳大利亚、2217
- St George Hospital
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Sydney、New South Wales、澳大利亚、1871
- Liverpool Hospital
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Sydney、New South Wales、澳大利亚、2052
- Royal Prince Alfred Hospital
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Sydney、New South Wales、澳大利亚、2217
- NSW Organ and Tissue Donation Service
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Tweed Heads、New South Wales、澳大利亚、2485
- The Tweed 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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Donation events identified by a patient who is a potential organ and tissue donor in a participating ICU or under the care of ICU health professionals.
- For the primary endpoint only, patients must not have registered their donation wishes.
Exclusion Criteria:
- A patient who is not medically suitable for organ or tissue donation.
- A patient who does not have next of kin available to participate in donation conversations.
- A patient in the ICU who is able to provide first person consent for deceased donation, for example a patient with spinal injuries.
- A patient who is suitable to donate only tissue after death.
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：不适用
- 介入模型：单组作业
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Communication intervention
This study uses a single arm design with current 'controls' to explore an intervention, the procedure for providing information and requesting consent for donation, that uses new agreed best practice procedures led by specially trained intensive care health professionals.
The study intervention is a staff education and training module intended to provide a framework and preparation for select critical care staff to conduct organ donation discussions in line with best practice.
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The intervention is a modification of current standard practice procedures for requesting consent for donation. The intervention period commences when the possibility of organ donation is first raised with the family, and includes the time for families to make a decision. This time may last up to 72 hours. |
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 |
|---|---|---|
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Proportion of families providing consent for deceased organ donation.
大体时间：Up to 72 hours subsequent to raising deceased donation with next of kin.
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Final decision of either written or verbal consent or decline to deceased organ donation provided at the hospital.
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Up to 72 hours subsequent to raising deceased donation with next of kin.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.
大体时间：90 days post enrollment.
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This outcome will be assesed using a telephone follow-up call.
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90 days post enrollment.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health professionals' adherence rates to core elements of the intervention.
大体时间：Up to 72 hours subsequent to next of kin making their final donation decision.
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This will be measured by observation and self-report at the hospital.
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Up to 72 hours subsequent to next of kin making their final donation decision.
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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：Robert Herkes、NSW Organ and Tissue Donation Service
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Potter JE, Perry L, Elliott RM, Aneman A, Brieva JL, Cavazzoni E, Cheng AT, O'Leary MJ, Seppelt IM, Herkes RG; COMFORT study investigators. Communication with Families Regarding Organ and Tissue Donation after Death in Intensive Care (COMFORT): a multicentre before-and-after study. Crit Care Resusc. 2018 Dec;20(4):268-276.
- Potter JE, Herkes RG, Perry L, Elliott RM, Aneman A, Brieva JL, Cavazzoni E, Cheng AT, O'Leary MJ, Seppelt IM, Gebski V; COMFORT study investigators. COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study. BMC Health Serv Res. 2017 Jan 17;17(1):42. doi: 10.1186/s12913-016-1964-7.
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)
2013年5月1日
初级完成 (实际的)
2016年7月8日
研究完成 (实际的)
2016年12月21日
研究注册日期
首次提交
2013年8月10日
首先提交符合 QC 标准的
2013年8月12日
首次发布 (估计)
2013年8月14日
研究记录更新
最后更新发布 (实际的)
2017年10月5日
上次提交的符合 QC 标准的更新
2017年10月3日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
其他研究编号
- DR-01-2012
- ACTRN12613000815763 (注册表标识符：Australian New Zealand Clinical Trials Registry (ANZCTR))
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.