A standardized labor induction protocol to reduce primary cesarean and racial disparities in labor outcomes: a prospective cohort study

减少初次剖宫产和分娩结果种族差异的标准化引产方案：一项前瞻性队列研究

• 批准号: 10468139
• 负责人: Rebecca Feldman Hamm
• 金额: $ 16.99万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10468139
• 关键词: Academic Training; Address; American College of Obstetricians and Gynecologists; Biometry; Birth; Black race; Caring; Cesarean section; Child Development; Child Health; Clinical; Data; Decision Making; Discipline of obstetrics; Enrollment; Epidemiology; Evaluation; Health Policy; Healthcare; Induced Labor; Institutes; Institution; Intervention; Interview; Leadership; Life; Literature; Maternal Health; Maternal-fetal medicine; Medical; Medicine; Mentorship; Methodology; Methods; Mission; Morbidity - disease rate; National Institute of Child Health and Human Development; Outcome; Patients; Pattern; Penetration; Physicians; Play; Population; Practice Management; Procedures; Prospective Studies; Prospective cohort; Prospective cohort study; Protocols documentation; Provider; Qualitative Methods; Race; Research; Research Design; Research Personnel; Role; Savings; Site; Standardization; Strategic Planning; Surveys; Testing; Training; Treatment Efficacy; Unconscious State; United States; Variant; Woman; Work; adverse outcome; black women; clinical care; clinical epidemiology; cohort; design; effectiveness evaluation; effectiveness study; effectiveness trial; efficacy study; evidence base; implementation evaluation; implementation intervention; implementation outcomes; implementation process; implementation research; implementation science; implicit bias; improved; improved outcome; innovation; interest; maternal morbidity; maternal outcome; neonatal morbidity; neonatal outcome; novel; obstetric outcomes; perinatal outcomes; post implementation; programs; racial disparity; racial health disparity; randomized trial; routine care; satisfaction; standardized care; success; therapy design; unconscious bias

PROJECT SUMMARY Nearly 1 in 3 deliveries in the United States occurs by cesarean section, with unacceptable racial disparities impacting that rate. Protocols to standardize care have been shown to decrease adverse outcomes across medicine, including in obstetrics. In addition to improving outcomes overall, studies in non-obstetric populations have demonstrated that care standardization can considerably reduce racial disparities in health by reducing care variation, thereby minimizing the effects unconscious bias can have on decision-making. Labor induction, one of the most common procedures in obstetrics, varies widely in practice patterns by provider and site. Thus, we propose a novel means of reducing the cesarean rate, as well as racial disparities in obstetric outcomes: standardization of labor induction. The central hypothesis of this proposal is that a labor induction protocol will standardize the use of evidence-based active labor management practices in induction, thereby improving outcomes such as cesarean delivery rate, maternal morbidity, and neonatal morbidity. In addition, we believe our intervention will inhibit implicit bias from playing a significant role in labor management, thus specifically decreasing morbidity for Black women. This proposal will leverage mentorship of senior investigators (Drs. Parry and Levine) and Penn’s research programs in maternal fetal medicine, implementation science, biostatistics/epidemiology, and qualitative methods. We plan to test our hypothesis by studying the effectiveness of a standardized labor induction protocol, while simultaneously collecting process implementation data in a prospective cohort design. Aim 1 will compare obstetric outcomes two years pre- to two-years post-implementation of the labor induction protocol into routine care at two diverse sites. Aim 1A will determine if the induction protocol reduces racial disparities in these critical obstetric outcomes. Aim 2 will utilize the innovative mixed-methodologies of implementation science, underused to date in obstetrics, to understand acceptability, penetration, and fidelity surrounding the induction protocol. These data will aid in preparing our intervention for implementation in the national arena. Evaluation of the use of standardized labor induction protocol to reduce cesarean rate and eliminate racial disparities is a significantly important clinical question yet to be studied in the literature. Dr. Hamm is a maternal fetal medicine physician trained in clinical epidemiology with an established interest in implementation research. The training she proposes in designing effectiveness trials, the methodologies of implementation science, and leadership in healthcare innovation will enable her to become an independent researcher studying the implementation of large-scale, evidence-based initiatives in obstetrics. By the conclusion of this program, she will be able to independently design, enact, and evaluate interventions to reduce obstetric morbidity. The results of the proposed K23 will be invaluable pilot work for a planned R01-level application.

项目摘要 剖宫产分区发生了近三分之一的交付，有不可接受的种族分布 影响该速度。已显示标准化护理的协议可以减少跨越的不良结果 医学，包括妇产科。除了改善总体结果外，对非口头群体的研究 已经证明，护理标准化可以考虑通过减少卫生中的种族分配 护理变化，从而最大程度地减少了无意识偏见对决策的影响。 劳动归纳是产科中最常见的程序之一，在实践模式下的差异很大 提供者和网站。这，我们提出了一种新颖的方法来降低剖宫产以及种族分布 在产科结果中：劳动归纳的标准化。该提议的中心假设是一项劳动 归纳协议将标准化基于证据的积极劳动管理实践在归纳中的使用， 从而提高了剖宫产，母体发病率和新生儿发病率等结果。在 此外，我们认为我们的干预将抑制隐性偏见在劳动中发挥重要作用 管理，因此特别降低了黑人妇女的发病率。该建议将利用心态 高级调查员（帕里博士和莱文）和宾夕法尼亚州的胎儿医学研究计划， 实施科学，生物统计学/流行病学和定性方法。 我们计划通过研究标准化实验室诱导方案的有效性来检验我们的假设， 同时在预期队列设计中同时收集过程实施数据。目标1意志 比较劳动归纳协议后两年前两年的产科结果 在两个潜水员站点进行常规护理。 AIM 1A将确定感应协议是否减少了种族分布 这些关键的产科结果。 AIM 2将利用实施的创新混合方法 科学迄今为止迄今未充分利用，以了解可接受性，渗透和忠诚度 归纳方案。这些数据将有助于准备我们在国家舞台上实施的干预措施。 评估使用标准化劳动诱导协议以降低剖宫产和消除 种族差异是文献中尚待研究的一个重要重要的临床问题。哈姆博士是 对临床流行病学培训的孕产妇胎儿医学对实施具有既定兴趣 研究。她在设计有效性试验时提出的培训，实施方法 科学和医疗保健创新领域的领导才能使她成为一名独立研究员 研究实施大规模的，基于证据的计划。从此结束 计划，她将能够独立设计，制定和评估干预措施以减少产科 发病率。拟议的K23的结果将是计划的R01级申请的宝贵试点工作。