Improving the consent process for pregnant mothers at risk of preterm delivery

改善有早产风险的孕妇的同意程序

• 批准号: 8765836
• 负责人: Frank Xavier Placencia
• 金额: $ 12.38万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8765836
• 关键词: Address; Affect; Caregivers; Caring; Child; Clinical; Consent; Counseling; Data; Decision Making; Development; Discipline of obstetrics; Education; Educational Models; Environment; Environment Design; Ethical Theory; Ethicists; Ethics; Family; Fetal Development; Fetus; Future; Goals; Hospitals; Infant; Infant Health; Informed Consent; Knowledge; Life; Long-Term Care; Long-Term Effects; Medical; Mentors; Modeling; Mothers; Nature; Neonatal; Outcome; Parents; Patients; Perinatal; Physicians; Pregnancy; Pregnant Women; Premature Birth; Premature Infant; Process; Qualifying; Reporting; Research; Research Design; Research Institute; Research Personnel; Resuscitation; Risk; Series; Shapes; Staging; Surveys; career development; congenital anomaly; end of life; evidence base; high risk infant; improved; interest; life-sustaining therapy; patient population; post intervention; pregnant; premature; prenatal; programs; prospective; public health relevance; satisfaction; skills

DESCRIPTION (provided by applicant): Candidate and environment: Dr. Placencia is an accomplished investigator in neonatal ethics. His long term goal is to become an independent investigator who uses empiric evidence to change, modify, or support the normative ethical standards. He has identified a mentor who pioneered this approach, the support of a premiere research institute and clinical environment, and designed a career development program to augment his research skills and expertise in ethics. With these critical components, he will be uniquely qualified to achieve his goals. Objective: Develop an ethical model for parental perinatal decision making about the care of high-risk infants, and develop a clinical model by which parental decision making may be improved. Study Design: SA 1: Develop an evidence based critical appraisal of the Best Interests Standard (BIS). SA 1.1: Survey parents of high risk infants to determine what information they want regarding the familial impact of providing long term care, how such information would have shaped their decision-making, and whether it would have been appropriate for them to consider these effects? SA 1.2: Defend an empirically and ethically justified critical appraisal of the BIS by incorporating data gathered in our previou surveys on the conceptualization of the BIS and in SA1.1. SA 2: Develop, assess, and disseminate a data-driven, ethically justified model for prenatal education of pregnant women and their partners on the consequences to the infant of premature delivery. SA 2.1: Create of a series of educational videos for pregnant women at 18-30 weeks gestation and their partners, describing the current stage of fetal development and what to expect if the fetus delivers premature. SA 2.2: Determine the efficacy of the video on parental knowledge via pre- and post- assessments. SA 2.3: Assess maternal satisfaction with educational impact via post intervention survey. SA 2.4: Assess impact on decision making regarding resuscitation or life sustaining therapy (LST) amongst patients who deliver prematurely at 22-26 weeks. SA 2.5: Assess physicians' satisfaction with educational impact for parents of infants born between 22-34 weeks and impact on decisions regarding resuscitation or LST for infants born at 22-26 weeks. Future RO1: SA 3: Adaption of our model of prenatal education for non-academic obstetric settings. Future RO1: SA 4: Expand the study of the video's impact on parental decision making. Future RO1: SA 5: Adaption of the model for parents of infants with known congenital anomalies.

描述（由申请人提供）：候选人和环境：博士胎盘是一个有成就的研究员在新生儿伦理。他的长期目标是成为一名独立的调查员，使用经验证据来改变，修改或支持规范的道德标准。他找到了一位开创这种方法的导师，得到了一流研究机构和临床环境的支持，并设计了一个职业发展计划来增强他的研究技能和伦理学专业知识。有了这些关键因素，他将是唯一有资格实现他的目标。目的：制定一个伦理模式，父母围产期决策的照顾高风险的婴儿，并制定一个临床模式，父母的决策可能会有所改善。研究设计：SA 1：对最佳利益标准（BIS）进行基于证据的批判性评价。 SA 1.1：调查高风险父母 婴儿，以确定他们想要什么样的信息，关于提供长期护理的家庭影响，这些信息将如何塑造他们的决策，以及它是否是适当的，他们考虑这些影响？ SA 1.2：通过整合我们以前关于BIS概念化的调查和SA1.1中收集的数据，为BIS的经验和伦理合理的批判性评估辩护。SA 2：制定、评估和传播一个数据驱动的、道德上合理的模式，对孕妇及其伴侣进行关于早产对婴儿后果的产前教育。 SA 2.1：为怀孕18-30周的孕妇及其伴侣制作一系列教育视频，描述胎儿发育的当前阶段以及如果胎儿早产会发生什么。 SA 2.2：通过前后评估确定视频对父母知识的有效性。 SA 2.3：通过干预后调查评估产妇对教育影响的满意度。 SA 2.4：评估在22-26周早产的患者中对复苏或生命维持治疗（LST）决策的影响。 SA 2.5：评估医生对教育对22-34周出生婴儿的父母的影响的满意度，以及对22-26周出生婴儿的复苏或LST决策的影响。未来的RO 1：SA 3：我们的产前教育模式适应非学术产科设置。未来RO 1：SA 4：扩大视频对父母决策影响的研究。未来的RO 1：SA 5：模型适用于已知先天性异常婴儿的父母。