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: 10366336
• 负责人: MIRIAM KUPPERMANN
• 金额: $ 39.98万
• 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/10366336
• 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.

围产期新生儿，出生在22 0/7 - 24 6/7周胎龄之间，不能在子宫外存活 没有支持。即使得到支持，这些新生儿中也有40%死亡，而在幸存者中，大约有一半的新生儿患有 中度至重度残疾。这些生育对家庭来说在经济上和情感上都是昂贵的，所有这些 黑人家庭的负担最重，因为黑人婴儿出生的可能性是极少数的三倍 早产由于死亡率高，结果可能很差，美国儿科学会呼吁 当家庭面临这些决定时， 他们会考虑，并最终选择是否尝试复苏或寻求姑息。我们的初步 研究表明，尽管有这些建议，但目前的循环决策模型并不是 共享、消息灵通或以患者为中心。提供的死亡率和发病率估计数是可变的， 不准确;关于产前干预的指导相互矛盾;以及护理或复苏的目标 偏好并不总是被引出的。通过向父母提供不一致的信息， 澄清护理的价值观和目标，提供者将父母置于错误决策的巨大风险中， 决策冲突和决策后悔我们以前的工作也表明，决策质量差， 产后父母心理健康状况不佳为了优化这些高风险的咨询遭遇，我们有 利用一种新的方法来设计，与患者和临床医生利益相关者合作，决策支持 Perivilable GOALS（围绕生命支持获得最佳对齐）决策支持工具 （夏令时）。该DST旨在帮助SDM了解新生儿复苏情况。外围目标DST 是专为父母审查独立于他们的临床医生，并打算补充，而不是取代， 临床咨询。DST的重点是提供以患者为中心的结局信息， 协助澄清有关新生儿结局的价值观。随着试点测试的完成，我们 准备进行一项多中心、随机对照试验，以测试Perivilable GOALS DST对以下方面的影响：a） 判定质量（即，共享决策，知识，决策冲突，决策满意度， 决定后悔），B）心理健康（即，产后抑郁、焦虑和创伤后压力 时期），和c）新生儿治疗偏好（即，复苏或舒适护理）。我们假设 使用目标数据集测试的参与者将提高决策质量，特别是在SDM方面 （主要结果）和改善的心理健康结果。这项工作有助于提高 通过确保更知情和以患者为中心的决策，我们的方法是 创新，因为我们在研究设计和最终临床实践中为患者提供了更强有力的声音。我们 由于我们试验地点的地区和机构多样性， 提高了普遍性，允许广泛应用和传播DST。