Promoting Shared Decision Making in Periviable Care: A randomized controlled trial of the Periviable GOALS Decision Support Tool

促进围产期护理中的共同决策：围产期目标决策支持工具的随机对照试验

• 批准号: 10693922
• 负责人: MIRIAM KUPPERMANN
• 金额: $ 38.75万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10693922
• 关键词: Promoting; Shared; Decision; Making; Periviable

Periviable neonates, born between 22 0/7 - 24 6/7 weeks gestational age, cannot survive outside of the womb without support. Even with support, 40% of these neonates die, and, among survivors, roughly half suffer moderate to severe disability. These births are financially and emotionally costly to families, and all of these burdens are most heavily born by Black families, as Black infants are 3 times more likely to be born extremely premature. Because mortality is high and outcomes can be poor, the American Academy of Pediatrics calls for shared decision making (SDM) when families face these decisions—so that parents are engaged in deliberations, and, ultimately, choose whether to attempt resuscitation or pursue palliation. Our preliminary research suggests that, despite these recommendations, the current model of periviable decision making is not shared, well-informed, or patient-centered. Mortality and morbidity estimates provided are variable and inaccurate; there is conflicting guidance regarding antenatal interventions; and goals of care or resuscitation preferences are not always elicited. By presenting parents with inconsistent information without eliciting and clarifying values and goals of care, providers place parents at substantial risk for misinformed decision making, decisional conflict, and decisional regret. Our previous work also shows that poor decision quality is associated with poor postpartum parental mental health. To optimize these high-stakes counseling encounters, we have utilized a novel approach to design, in partnership with patient and clinician stakeholders, a decision support intervention - the Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST). This DST is meant to facilitate informed SDM regarding neonatal resuscitation. Periviable GOALS DST is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. With the completion of pilot testing, we are ready to conduct a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on: a) decision quality (i.e., shared decision-making, knowledge, decisional conflict, decision satisfaction, and decision regret), b) mental health (i.e., depression, anxiety, and post-traumatic stress in the postpartum period), and c) neonatal treatment preference (i.e., resuscitation or comfort care). We hypothesize that participants who utilize the GOALS DST will have improved decision quality, particularly in regard to SDM (primary outcome), and improved mental health outcomes. This work stands to improve the quality of periviable care by ensuring more informed and patient-centered decision-making. Our methodology is innovative, as we are offering patients a stronger voice in research design and, ultimately, clinical practice. Our results will have immediate clinical relevance because the regional and institutional diversity of our trial sites improves generalizability, allowing for broad application and dissemination of the DST.

生长的新生儿，出生于22 0/7-24 6/7周胎龄，无法在女人之外生存 没有支持。即使得到支持，这些新生儿中有40％死亡，在生存中，大约一半遭受 中度至重度残疾。这些出生对家庭来说在经济和情感上都是昂贵的，所有这些 伯伦斯最沉重的是黑人家庭，因为黑人婴儿出生的可能性高3倍 早产。由于死亡率很高，结果可能很差，因此美国儿科学会要求 当家人面临这些决定时，共享决策（SDM） - 以便父母参与 审议，最终选择是尝试复苏还是购买palliation。我们的初步 研究表明，目的地这些建议，当前的可涉及决策模型不是 共享，信息良好或以患者为中心。提供的死亡率和发病率估计是可变的，并且 不准确；关于静脉干预措施有矛盾的指导；和护理或复苏的目标 偏好并不总是引起的。通过向父母提供不一致的信息而不引起和 澄清的价值和护理目标，提供者将父母面临误导决策的巨大风险， 决策冲突和决策的遗憾。我们以前的工作还表明，决策质量差是相关的 产后父母心理健康。为了优化这些高风险的咨询，我们有 利用一种新颖的方法来设计与患者和临床利益相关者合作的决策支持 干预 - 可行的目标（围绕生活支持的最佳一致）决策支持工具 （DST）。该DST旨在促进有关新生儿复苏的知情SDM。可实现的目标dst 专为父母而设计的，以独立于临床审查，并旨在补充，不取代， 临床咨询。 DST的重点是提供以患者为中心的结果信息和 关于新生儿结果的价值澄清的帮助。随着试点测试的完成，我们是 准备进行多站点，随机对照试验，以测试可渗透目标DST的效果：a） 决策质量（即共享决策，知识，决策冲突，决策满意度以及 遗憾），b）心理健康（即产后抑郁，动画和创伤后压力 时期）和c）新生儿治疗偏好（即复苏或舒适护理）。我们假设这一点 利用目标DST的参与者将提高决策质量，尤其是SDM （主要结果），并改善了心理健康结果。这项工作将提高 通过确保更明智和以患者为中心的决策来确保可行的护理。我们的方法是 创新，因为我们为患者提供了研究设计和最终临床实践的更强烈的声音。我们的 结果将立即具有临床相关性，因为我们试验地点的区域和机构多样性 提高普遍性，允许广泛应用和传播DST。