Handoffs and Transitions in Critical Care - Understanding Scalability

项目总结： 《重症监护中的移交和过渡--急性护理实施研究伦理》 (HATRICC-AIRE)“ 迫切需要确定适用于快节奏、高风险的实施策略 危重护理的环境，这一环境在实施科学文献中没有得到充分的描述。在 同时，这种研究必须以道德的方式进行，尊重研究的权利 研究对象。调查人员和研究伦理委员会在评估实施中的伦理问题上面临着反复出现的困难 研究，提出了在突出的医学领域中尚未明确或全面解决的问题 道德准则。例如，常常不清楚卫生专业人员是否受到 执行情况研究应被视为“研究对象”，它们是否以及如何提供信息 同意，以及哪些看门人可以适当地允许机构参与 实施试验。与此同时，医疗保健专业人员面临着许多潜在的风险， 实施研究，包括对某些护理做法的制裁，改变与同事的关系， 与患者和家人的关系改变，临床工作流程中断，以及决定 选择退出实施研究。在这个项目中，我们使用定性的方法来揭示和探索挑战 关于急性护理环境中实施研究的合乎道德的行为。我们将引出不同的观点 急性护理实施研究的利益相关者，包括临床医生和其他一线员工、临床 和行政领导，以及机构审查委员会成员。然后，我们将完善当前的研究伦理 框架，以更密切地应对执行研究提出的独特挑战。最接近的 这项工作的目标是促进由父母赠款支持的混合有效性-执行研究。这个 较长期的目标是通过制定一个框架来指导实施研究的道德行为，该框架可以 在未来基于急性护理的研究中使用。这项研究的发现将发表在科学杂志上。 方便文献的广泛使用。这项工作对公众健康的潜在影响是显著的，因为 由此产生的道德框架将有意义地增强调查人员进行符合道德的、严格的急性护理的能力 实施研究旨在缩小证据与实践之间的差距。这个项目是针对生物伦理学的。 研究；它与美国国立卫生研究院对研究中的生物伦理问题的兴趣有关，包括临床接口 学习型卫生系统中的研究和临床护理以及获取和记录信息的方法 同意。这也与NHLBI对与实施科学相关的生物伦理问题的兴趣有关 研究。

PROJECT SUMMARY: “Handoffs and Transitions in Critical Care – Acute care Implementation Research Ethics (HATRICC-AIRE)” There is an urgent need to characterize implementation strategies suitable for use in the fast-paced, high stakes environment of critical care, a setting that is underrepresented in the implementation science literature. At the same time, such research must be conducted in an ethical fashion, one that respects the rights of research subjects. Investigators and research ethics boards face recurrent difficulties evaluating ethics in implementation research, which presents issues that have not been clearly or comprehensively addressed in prominent medical ethical guidelines. For example, it is frequently unclear whether the health professionals targeted by implementation studies should be considered “research subjects,” whether and how they should give informed consent, and which gatekeepers can appropriately give permission for institutions to participate in implementation trials. Healthcare professionals are meanwhile exposed to a number of potential risks by implementation research, including sanction for certain care practices, altered relationships with colleagues, altered relationships with patients and families, interruptions to clinical workflow, and retaliation for deciding to opt out of an implementation study. In this project, we use qualitative methods to unmask and explore challenges to the ethical conduct of implementation research in acute care settings. We will elicit the perspectives of diverse stakeholders in acute care implementation research, including clinicians and other frontline employees, clinical and administrative leaders, and institutional review board members. We will then refine current research ethics frameworks to more closely address the unique challenges raised by implementation research. The proximate goal of this work is to facilitate the hybrid effectiveness-implementation study supported by the parent grant. The longer-term goal is to guide the ethical conduct of implementation research by developing a framework that can be employed in future studies based in acute care. The findings of this study will be disseminated in the scientific literature to facilitate widespread use. The potential public health impact of this work is significant because the resulting ethical framework will meaningfully augment investigators’ ability to conduct ethical, rigorous acute care implementation research aimed at narrowing the evidence-to-practice gap. This project is specific to bioethics research; it is relevant to the NIH’s interest in bioethical issues in research including the interface of clinical research and clinical care in the learning health system and methods for obtaining and documenting informed consent. It is also relevant to the NHLBI’s interest in bioethical questions related to implementation science research.