Handoffs and Transitions in Critical Care - Understanding Scalability

重症监护中的交接和过渡 - 了解可扩展性

基本信息

批准号：
10364299
负责人：
Meghan Brooks Lane-Fall
金额：
$ 14.46万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10364299
关键词：
Address Affect Age Agreement Authorization documentation Behavior Bioethical Issues Bioethics Caring Characteristics Clinical Clinical Research Cluster randomized trial Communities Consent Consent Forms Critical Care Dissemination and Implementation Employee Environment Equilibrium Ethical Issues Ethics Ethnic Origin Evaluation Research Evidence based intervention Exposure to Face Family Freedom Frequencies Funding Future Gatekeeping Gender Goals Guidelines Health Professional Health system Healthcare Individual Informed Consent Institution Institutional Review Boards Interruption Intervention Interview Knowledge Learning Literature Medical Methods Morals National Heart, Lung, and Blood Institute Outcome Parents Participant Patients Persons Public Health Qualitative Methods Quasi-experiment Race Randomized Clinical Trials Recurrence Reporting Research Research Ethics Research Personnel Research Subjects Research Training Rights Risk Role Sampling Site Structure Time Translational Research Translations United States National Institutes of Health Work acute care authority base care delivery clinical care cluster trial community engagement demographics design effectiveness implementation study effectiveness implementation trial group intervention human subject protection implementation research implementation science implementation strategy implementation study implementation trial improved interest member parent grant recruit response routine practice social group welfare

项目摘要

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.

项目概要： “重症监护中的交接和过渡——急性护理实施研究伦理（HATRICC-AIRE）” 迫切需要确定适合在快节奏、高风险的情况下使用的实施策略重症监护环境，这一环境在实施科学文献中代表性不足。同时，此类研究必须以符合道德的方式进行，即尊重研究权利研究人员和研究伦理委员会在评估实施过程中的伦理方面经常面临困难。研究提出了著名医学中尚未明确或全面解决的问题例如，经常不清楚卫生专业人员是否受到道德准则的影响。实施研究应被视为“研究对象”，它们是否以及如何提供同意，以及哪些看门人可以适当地允许机构参与实施试验中，医疗保健专业人员面临许多潜在风险。实施研究，包括对某些护理实践的制裁、与同事的关系、与患者和家属的关系改变、临床工作流程中断以及对决定的报复在这个项目中，我们使用定性方法来揭示和探索实施挑战。我们将征求不同观点的意见。急症护理研究的利益相关者，包括实施扩音器和其他一线员工、临床然后，我们将完善当前的研究道德。更紧密地解决实施研究提出的独特挑战的框架。这项工作的目标是促进由家长赠款支持的混合有效性实施研究。长期目标是通过开发一个框架来指导实施研究的道德行为这项研究的结果将在未来的急性护理研究中得到应用。促进广泛使用的文献。这项工作的潜在公共卫生影响是重大的，因为由此产生的道德框架将有意义地增强研究人员进行道德、严格的急性护理的能力旨在缩小证据与实践差距的实施研究该项目专门针对生物伦理学。研究；与 NIH 对研究中的生物伦理问题的兴趣相关，包括临床界面学习健康系统中的研究和临床护理以及获取和记录知情的方法这也与 NHLBI 对与实施科学相关的生物伦理问题的兴趣有关。研究。