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

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，在过去十年中增长了约50%。选择性重复CD(ERCD)是剖宫产率上升的重要原因，是初次CD增加和剖宫产后阴道分娩(VBAC)减少共同作用的结果。VBAC发生率下降的一个主要原因是符合条件的妇女选择剖宫产后分娩试验(TOLAC)的频率下降。这一下降的原因尚不清楚；尤其是，人们对患者偏好在多大程度上导致了这种下降知之甚少。此外，缺乏帮助患者和提供者参与患者偏好驱动的、关于剖宫产后分娩方法的共享决策的工具。我们建议1)在240名讲英语或西班牙语的女性中确定患者对分娩方法(TOLAC或ERCD)和模式(VBAC或CD)的偏好驱动因素；2)使用这些数据创建创新的个性化决策支持mHealth应用程序(Preor CD Decision App)，该应用程序将价值澄清练习与有效的VBAC预测工具相结合；以及3)在1650名讲英语或西班牙语的妇女中进行一项随机试验，比较Preor CD Decision App和常规护理，以评估其对TOLAC和VBAC比率和决策质量的影响。我们的假设是，与只接受常规护理的女性相比，随机使用Preor CD Decision App的女性更有可能接受TOLAC和VBAC，经历较少的决策冲突，更了解TOLAC和ERCD，并体验更优化的共享决策。

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.