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临床试验/NCT03908346
NCT03908346已完成不适用

A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年7月21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
41
试验地点
2
主要终点
Effectiveness - Knowledge

研究概览

简要总结

This study will test the feasibility and acceptability of deploying a decision aid for surrogate decision makers of comatose survivors of cardiac arrest early during hospitalization. This decision aid is to inform, educate and support decision makers charged with determining goals of care during post-cardiac arrest treatment.

详细描述

Survival and neurological recovery after out-of-hospital cardiac arrest are highly variable, driven in part by inconsistent hospital care following successful resuscitation. International guidelines for post-cardiac arrest care recommend delaying neurologic prognostication until 72-hours after resuscitation because early prognostication is imprecise and may precipitate inappropriate withdrawal of life sustaining therapy (WLST). Early WLST has been observed in-post cardiac arrest care. In order to encourage better guideline concordant care, the study proposes the implementation of an educational tool to support and inform surrogate decision makers in post-cardiac arrest care and neuro-prognostication. This pilot study will test the feasibility of implementing an educational tool for surrogate decision makers, the acceptability of such an intervention and early measures of knowledge translation. This study will inform the creation of a randomized controlled trial to test the ability of the tool to encourage guideline concordant timing of post-cardiac arrest neuro-prognostication.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18 years of age and older
  • Identified as a surrogate decision maker for patient who is a comatose survivor of out of hospital cardiac arrest

排除标准

  • Illiterate or poor proficiency (unable to read decision aid)
  • Non-english speaking

结局指标

主要结局

Effectiveness - Knowledge

时间窗: Through study completion, on average 2.5 years

Determine the number of individuals who reviewed the educational tool and completed the follow up knowledge evaluation. The pre-knowledge and post-knowledge/acceptability surveys will establish how effective the tool was at relaying information to the surrogate decision maker.

Adoption

时间窗: Through study completion, on average 2.5 years

To maximize adoption, 8-10 qualitative interviews will be conducted with emergency medicine providers, nurses and ancillary staff to explore barriers to use and potential adaptations to the implementation that might improve real world use. Providers who did not deploy the device will be included in order to understand their reasons for not adopting the intervention. Surrogate decision makers who did not agree to participate in the pilot intervention will be queried to understand their reasons for non-participation.

Reach

时间窗: Through study completion, on average 2.5 years

To establish Reach, the investigators will determine the following: (1) number of out-of hospital cardiac arrests that present to the University of Colorado Hospital (UCH) ED; (2) number of Out of Hospital Cardiac Arrest (OHCA) patients with family/surrogate decision makers in the ED; (3) number of surrogate decision makers who agree to participate. Establishing reach is integral as it will allow us to determine the feasibility of intervening in the ED and will characterize the difficulties enrolling decision makers. The research assistant will keep a running tabulation of these data.

Implementation

时间窗: Through study completion, on average 2.5 years

In order to assess implementation (and prepare for larger implementation) a work-flow analysis will be conducted of the post-cardiac educational tools within the UCH ED. Nurses, ancillary staff (chaplain, social worker) who participate in family meetings within the emergency department will be queried. Via work-flow analysis, an understanding will be gained about when the tool was deployed, potential barriers/facilitators to deployment and how to best implement in a busy ED.

次要结局

  • Effectiveness - Patient Outcomes(Through study completion, on average 2.5 years)
  • Effectiveness - Decision Quality(Through study completion, on average 2.5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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