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

项目总结 在美国，近三分之一的分娩是通过剖腹产进行的，存在不可接受的种族差异 影响了这一速度。标准化护理方案已被证明可减少以下方面的不良后果 医学，包括产科。除了改善总体结果外，在非产科人群中的研究 已经证明，护理标准化可以通过减少卫生保健中的种族差异 护理差异，从而将无意识偏见对决策的影响降至最低。 引产是产科最常见的程序之一，在实践模式上有很大的不同 提供商和站点。因此，我们提出了一种新的方法来降低剖宫产率和种族差异。 产科结局：引产的标准化。这一提议的中心假设是，一个劳工 入职议定书将规范入职中基于证据的积极劳动管理做法的使用， 从而改善剖宫产率、孕产妇发病率和新生儿发病率等结局。在……里面 此外，我们认为我们的干预将抑制隐性偏见在分娩中发挥重要作用 管理，从而特别减少黑人妇女的发病率。这项提案将利用导师关系 高级研究人员(帕里和莱文博士)和宾夕法尼亚大学在母体胎儿医学方面的研究项目， 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引产方案的有效性来检验我们的假设， 同时收集前瞻性队列设计中的过程实施数据。目标1将 比较引产方案实施前两年和实施后两年的产科结局 在两个不同的地点进行常规护理。目标1A将确定诱导方案是否减少了 这些关键的产科结局。目标2将利用创新的混合实施方法 科学，到目前为止还没有在产科使用，以了解围绕着 入职协议。这些数据将有助于我们为在国家舞台上实施干预措施做准备。 标准化引产程序用于降低剖宫产率和消除剖宫产率的效果评价 种族差异是尚未在文献中研究的一个重要的临床问题。哈姆博士是一位 受过临床流行病学培训的孕妇胎儿医学医生，对实施有明确的兴趣 研究。她建议在设计有效性试验、实施方法论方面进行培训 科学，以及在医疗创新方面的领先地位将使她成为一名独立研究员 研究在产科实施大规模的循证计划。以此为结论 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的结果将是计划中的R01级应用程序的宝贵试点工作。

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.