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

描述（由申请人提供）：剖宫产（CD）占美国所有分娩的三分之一，在过去十年中增长了约50%。选择性重复CD （ERCD）是剖宫产率上升的一个重要因素，其原因是原发性CD率上升和剖宫产后阴道分娩（VBAC）率下降。VBAC频率下降的主要驱动因素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，对于患者的偏好在多大程度上促成了这种减少，人们知之甚少。此外，缺乏帮助患者和提供者参与以患者偏好为导向的关于剖宫产后分娩方法的共同决策的工具。我们建议：1)在240名英语或西班牙语TOLAC合格的妇女中确定患者偏好驱动因素（TOLAC或ERCD）和分娩方式（VBAC或CD）；2)利用这些数据创建一个创新的、个性化的决策支持移动健康应用程序（Prior CD decision app），该应用程序将价值澄清练习与经过验证的VBAC预测工具相结合；3)在1650名英语或西班牙语女性中进行一项随机试验，将Prior CD Decision App与常规护理进行比较，以评估其对TOLAC和VBAC率以及决策质量的影响。我们的假设是，与只接受常规护理的女性相比，随机选择使用先验CD决策应用程序的女性更有可能接受TOLAC和VBAC，并且会经历更少的决策冲突，对TOLAC和ERCD有更多的了解，并经历更优化的共同决策。

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.