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.

Project Narrative Periviable birth is among the leading causes of infant death and childhood disability, with disproportionate impact in low-income and minority communities, and although relatively rare, the CDC estimates that extremely premature deliveries result in societal costs exceeding $26 billion dollars annually. To optimize high-stakes periviable counseling encounters, we propose to test, in a multisite, randomized controlled trial, a decision support intervention (i.e., Periviable GOALS DST) developed by our research team to facilitate informed, shared decision-making regarding neonatal resuscitation among women who present to labor and delivery at periviable gestations (from 22 0/7 to 24 6/7 weeks gestational age) and their physicians. The proposed work stands to improve the quality of periviable care by enabling more informed and patient-centered decisions, and our results will have immediate clinical relevance because the regional and institutional diversity of our trial sites, which improves generalizability, allowing for broad application and dissemination of the tool.