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