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: 10038654
• 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/10038654
• 关键词: Academic Training; Address; American College of Obstetricians and Gynecologists; Biometry; Birth; Caring; Cesarean section; Child Development; Child Health; Clinical; Data; Decision Making; Discipline of obstetrics; Effectiveness; 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; Process; 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; clinical care; clinical epidemiology; cohort; design; effectiveness evaluation; effectiveness trial; efficacy study; evidence base; implementation research; implementation science; implicit bias; improved; improved outcome; innovation; interest; maternal morbidity; maternal outcome; neonatal morbidity; neonatal outcome; novel; obstetric outcomes; perinatal outcomes; programs; racial disparity; racial health disparity; randomized trial; routine care; satisfaction; standardized care; success; successful intervention; 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 在美国，近三分之一的分娩是通过剖腹产进行的，种族差异是不可接受的 影响这个速度。标准化护理方案已被证明可以减少不良结局， 医学，包括产科。除了改善总体结果外，在非产科人群中进行的研究 已经证明，护理标准化可以大大减少健康方面的种族差异， 护理差异，从而最大限度地减少无意识偏见对决策的影响。 引产是产科最常见的程序之一，在实践模式上有很大差异， 供应商和网站因此，我们提出了一种新的方法来降低剖宫产率，以及种族差异 产科结局：引产的标准化。这一提议的核心假设是， 诱导方案将标准化在诱导中使用基于证据的积极分娩管理实践， 从而改善诸如剖腹产率、产妇发病率和新生儿发病率的结果。在 此外，我们相信我们的干预将抑制内隐偏见在劳动中发挥重要作用， 管理，从而特别减少黑人妇女的发病率。该提案将利用导师制 高级研究人员（帕里博士和莱文博士）和宾夕法尼亚大学在母胎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验证我们的假设， 同时在前瞻性队列设计中收集过程实施数据。目标1将 比较引产方案实施前两年与实施后两年的产科结局 在两个不同的地方进行常规护理目标1A将确定诱导方案是否减少了 这些关键的产科结果。目标2将利用创新的混合执行方法 科学，迄今为止在产科中未被充分使用，以了解可接受性，渗透性和围绕 诱导方案。这些数据将有助于我们准备在国家竞技场实施干预措施。 规范化引产方案对降低剖宫产率及消除剖宫产的效果评价 种族差异是一个非常重要的临床问题，尚未在文献中进行研究。哈姆医生是一个 接受过临床流行病学培训的母胎医学医生，对实施有兴趣 research.她提出的设计有效性试验的培训， 科学和医疗创新的领导力将使她成为一名独立的研究人员 研究在产科实施大规模循证举措。通过这一结论， 计划，她将能够独立设计，制定和评估干预措施，以减少产科 发病率建议的K23的结果将是计划中的R 01级应用的宝贵试点工作。