Effect of a patient-centered decision app on TOLAC: An RCT

以患者为中心的决策应用程序对 TOLAC 的影响：随机对照试验

• 批准号: 8885864
• 负责人: MIRIAM KUPPERMANN
• 金额: $ 63.74万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-10 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8885864
• 关键词: Accounting; Address; Benefits and Risks; Birth; Caring; Clinical; Conflict (Psychology); Data; Decision Making; Discipline of obstetrics; Effectiveness; Exercise; Frequencies; Goals; Health; Health Technology; Intervention; Knowledge; Language; Lead; Measures; Neonatal; Outcome; Patient Preferences; Patients; Population; Probability; Provider; Public Health; Randomized; Risk; Role; Trial of Labor; Vaginal Birth after Cesarean; Woman; Work; base; cohort; evidence base; experience; improved; innovation; mHealth; maternal morbidity; patient oriented; preference; pregnant; primary outcome; randomized trial; shared decision making; tool; treatment as usual

DESCRIPTION (provided by applicant): Cesarean delivery (CD) accounts for one-third of all births in the US, representing an increase of approximately 50% in the last decade. Elective repeat CDs (ERCD) are a significant contributor to the rising cesarean rate, resulting from the combination of an increasing rate of primary CD and a decreasing rate of vaginal birth after cesarean (VBAC). A primary driver of the decreased frequency of VBAC is the decline in frequency with which eligible women elect a trial of labor after cesarean (TOLAC). The reasons for this decline are unclear; in particular, little is known about the extent to which patient preferences have contributed to this decrease. In addition, tools to help patients and providers engage in patient-preference driven, shared decision making regarding approach to delivery after cesarean are lacking. We propose to 1) identify patient preference drivers of delivery approach (TOLAC or ERCD) and mode (VBAC or CD) among 240 English- or Spanish-speaking TOLAC-eligible women; 2) use this data to create an innovative, personalized decision support mHealth app (Prior CD Decision App) that integrates values clarification exercises with a validated VBAC prediction tool; and 3) conduct a randomized trial of the Prior CD Decision App versus usual care among 1650 English- or Spanish-speaking women to assess its effect on TOLAC and VBAC rates and decision quality. Our hypotheses are that compared to women who receive only usual care, women who are randomized to use the Prior CD Decision App will be more likely to undergo TOLAC and have a VBAC and will experience less decisional conflict, be more knowledgeable about TOLAC and ERCD and experience more optimal shared decision making.

描述（由申请人提供）：剖腹产 (CD) 占美国新生儿总数的三分之一，在过去十年中增加了约 50%。选择性重复 CD (ERCD) 是剖宫产率上升的一个重要因素，这是原发性 CD 率上升和剖宫产后阴道分娩 (VBAC) 率下降共同作用的结果。 VBAC 频率下降的主要原因是符合条件的妇女选择剖宫产后试产 (TOLAC) 的频率下降。这种下降的原因尚不清楚；特别是，对于患者偏好在多大程度上导致了这种下降，我们知之甚少。此外，还缺乏帮助患者和医疗服务提供者就剖腹产后分娩方式进行患者偏好驱动的共同决策的工具。我们建议 1) 在 240 名符合 TOLAC 资格的讲英语或西班牙语的女性中确定分娩方式（TOLAC 或 ERCD）和模式（VBAC 或 CD）的患者偏好驱动因素； 2) 使用这些数据创建创新的个性化决策支持 mHealth 应用程序（Prior CD Decision App），该应用程序将价值观澄清练习与经过验证的 VBAC 预测工具集成在一起； 3) 在 1650 名讲英语或西班牙语的女性中对 Prior CD Decision App 与常规护理进行随机试验，以评估其对 TOLAC 和 VBAC 率以及决策质量的影响。我们的假设是，与仅接受常规护理的女性相比，被随机分配使用 Prior CD Decision App 的女性将更有可能接受 TOLAC 并进行 VBAC，并且会经历更少的决策冲突，对 TOLAC 和 ERCD 更加了解，并体验更优化的共同决策。