Decision-making for Infants with Complex Life-Threatening Conditions

描述（由申请人提供）：决策的婴儿与复杂的危及生命的条件摘要婴儿与危及生命的条件谁早些时候会在生命的头几个月死亡，现在正在接受高度复杂的，有时实验性的治疗，旨在治愈的条件或延长寿命。然而，这些治疗具有不确定的结果，婴儿死亡的风险很高，如果他们活着，他们将面临严重的发病率。患有这些疾病的婴儿经历了一个不确定的轨迹，通常涉及多种健康危机，需要父母和医疗保健提供者对治疗的类型和水平做出关键决定。决策跨越了从是否开始治疗、如何改变治疗以应对医疗危机、是否从积极的治疗性护理转向以症状为中心的姑息治疗，到是否撤回治疗的连续统一体。这项为期5年的研究将采用纵向病例研究设计，以检查婴儿因复杂的危及生命的疾病（CLTC）接受生命维持治疗的决策轨迹。本研究的重点是三组死亡风险特别高和终生发病率显著的CLTC婴儿：极早产儿（妊娠<26周），复杂心脏畸形婴儿和需要造血干细胞移植（HSCT）的遗传诊断婴儿。将研究四十个案例，每个案例将包括婴儿、父母、提供者和护理的物理环境。将在出生或诊断后对病例成员进行叙述性访谈和自我报告测量，此后至少每月一次，直至死亡或入组后1年。一个案例内和跨案例分析将被用来探索这些婴儿的决策轨迹，并检查决策是如何以及何时跨越疾病轨迹。该研究将确定整个轨迹的过渡点，并确定影响决策的因素，例如父母希望的参与程度;希望更多或更少参与的父母的特征;以及医疗保健提供者在决策中可以发挥的作用。研究结果将用于制定CLTC婴儿的决策和疾病轨迹转变点的类型学。这些将为制定干预措施提供基础，以促进这些婴儿的决策。公共卫生相关性：本研究将采用纵向多病例研究设计，以检查复杂危及生命的疾病（CLTC）婴儿的决策轨迹，以及从出生或诊断到死亡或12个月对父母决策的影响。这项研究将是第一项前瞻性研究所有类型的健康相关决策的轨迹（治疗开始和强化，从治疗性护理到姑息治疗的治疗转变，暂停或撤销治疗）在长达一年的疾病轨迹中，在多个CLTC婴儿人群中，无论是死亡还是存活。此外，极早产儿（妊娠<26周）、患有复杂先天性心脏病（CHD）的婴儿和患有需要造血干细胞移植（HSCT）的遗传诊断的婴儿的样本将允许探索对于接受三种最常见的儿科死亡原因的实验性治疗的婴儿，决策是如何相似和不同的。我们将确定决策过程中的过渡点，并确定对决策的影响，如父母希望的参与程度;希望更多或更少参与的父母的特征;以及医疗保健提供者在决策中扮演的角色。目标是确定整个轨迹的过渡点，并为制定干预措施提供基础，以促进父母为这些婴儿做出决策。

DESCRIPTION (provided by applicant): Decision-Making For Infants with Complex Life-Threatening Conditions Abstract Infants with life-threatening conditions who earlier would have died in the first months of life are now receiving highly complex and sometimes experimental treatments designed to cure the condition or prolong life. However, these treatments have uncertain outcomes, the infants are at high risk for death, and if they live face a life-span of significant morbidity. Infants with these conditions experience an uncertain trajectory that typically involves multiple health crises requiring parents and health care providers to make critical decisions about the type and level of treatment. Decisions span the continuum from whether to initiate treatment, how to alter the treatment to respond to a medical crisis, whether to shift from aggressive curative care to symptom- focused palliative care, to whether to withdraw treatment. This 5-year study will use a longitudinal, case study design to examine the trajectory of decision making for infants undergoing life-sustaining treatment for complex life-threatening conditions (CLTC). Three groups of infants with CLTCs who are at particularly high risk for death and significant life-span morbidity are the focus of this study: extremely preterm infants (<26 weeks gestation), infants with complex cardiac anomalies, and infants with genetic diagnoses requiring a hematopoietic stem cell transplant (HSCT). Forty cases will be studied and each case will include the infant, parents, providers and the physical context of caregiving. Narrative interviews and self-report measures will be used with case members following birth or diagnosis and at least monthly thereafter until death or 1 year following enrollment. A within-case and cross-case analysis will be used to explore the trajectory of decision making for these infants and examine how and when decisions are across the illness trajectory. The study will identify transition points across the trajectory and identify factors influencing decision making, such as the level of involvement that parents' want; characteristics of parents who desire more or less involvement; and roles health care providers can play in decision making. The findings will be used to develop typologies of decision making and illness trajectory transition points for infants with CLTCs. These will provide a foundation for developing interventions to facilitate the decision making for these infants. PUBLIC HEALTH RELEVANCE: This study will use a longitudinal multiple case study design to examine the trajectory of decision making for infants with complex life-threatening conditions (CLTC) and influences on parents' decision making from birth or diagnosis until death or 12 months. This study will be the first study to prospectively examine the trajectory of all types of health-related decisions (treatment initiation and intensification, shifts in treatment from curative care to palliative care, withholding or withdrawing treatment) across a year-long illness trajectory, in multiple populations of infants with CLTCs, both those who die and those who survive. In addition, the sample of extremely premature infants (<26 weeks gestation), infants with complex congenital heart disease (CHD), and infants with genetic diagnoses requiring a hematopoietic stem cell transplant (HSCT) will allow for exploration of how decision making is both similar and different for infants undergoing experimental treatment for the three most common causes of pediatric death. We will identify transition points across the trajectory of decision making and identify the influences on decision making, such as the level of involvement that parents' want; characteristics of parents who desire more or less involvement; and roles health care providers play in decision making. The goal will be to identify transition points across the trajectory and provide a foundation for developing interventions to facilitate parents' decision-making for these infants.