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

围产儿出生在22.0/7-24.6/7周之间，不能在子宫外存活 没有支持的话。即使有了支持，这些新生儿中也有40%死亡，而在幸存者中，大约有一半遭受痛苦 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 黑人家庭出生的负担最重，因为黑人婴儿出生的可能性是黑人家庭的3倍 还为时过早。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，共享决策(SDM)-以便父母参与 商议，并最终选择是尝试复苏还是寻求姑息。我们的预赛 研究表明，尽管有这些建议，但目前危险的决策模式并不是 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值是可变的 不准确；关于产前干预的指导意见相互矛盾；护理或复苏的目标 偏好并不总是能引出的。通过向父母提供不一致的信息而不引出 阐明护理的价值和目标，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。我们之前的工作也表明，糟糕的决策质量与 产后父母心理健康状况不佳。为了优化这些高风险的咨询接触，我们有 利用一种新的方法，与患者和临床医生利益相关者合作，设计决策支持 干预-危险目标(围绕生命支持获得最佳匹配)决策支持工具 (DST)。此DST旨在促进有关新生儿复苏的知情SDM。危险目标DST 旨在供父母独立于临床医生进行审查，旨在补充而不是取代， 临床医生咨询。DST的重点是提供以患者为中心的结果信息和 协助澄清新生儿结局的价值。随着试点测试的完成，我们正在 准备进行多点随机对照试验，以测试危险目标DST对以下方面的影响：a) 决策质量(即共享决策、知识、决策冲突、决策满意度和 决定后悔)，b)心理健康(即产后抑郁、焦虑和创伤后应激 (C)新生儿治疗偏好(即复苏或舒适护理)。我们假设 使用Goals DST的参与者将提高决策质量，特别是在SDM方面 (主要结果)，并改善精神健康结果。这项工作将提高产品的质量 通过确保更知情和以患者为中心的决策，提供可持续的护理。我们的方法是 创新，因为我们在研究设计和最终的临床实践中为患者提供了更强的发言权。我们的 结果将具有直接的临床意义，因为我们试验地点的地区和机构多样性 提高可概括性，使DST得以广泛应用和传播。

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.