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: 9274339
• 负责人: MIRIAM KUPPERMANN
• 金额: $ 63.38万
• 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/9274339
• 关键词: Address; Benefits and Risks; Birth; Caring; Cesarean section; Clinical; Conflict (Psychology); Data; Decision Making; Discipline of obstetrics; Effectiveness; Eligibility Determination; Exercise; Frequencies; Goals; Health Technology; Intervention; Knowledge; Language; Measures; 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; neonatal outcome; patient oriented; personalized decision; preference; pregnant; primary outcome; public health relevance; 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）：剖宫产（CD）占美国所有出生的三分之一，在过去十年中，大约增加了50％。选择性重复CD（ERCD）是剖宫产率上升的重要原因，这是由于原发性CD的增加和剖宫产后阴道出生率降低的组合所致（VBAC）。 VBAC频率降低的主要驱动力是符合条件的妇女选举剖宫产后（TOLAC）的劳动试验的频率下降。这种下降的原因尚不清楚。特别是，关于患者偏好导致这种减少的程度知之甚少。此外，缺乏剖宫产后，可以帮助患者和提供者从事以患者为驱动的，共同的决策。我们建议1）在240名英语或西班牙语符合TOLAC的女性中，确定患者偏好驱动力驱动方法（TOLAC或ERCD）和模式（VBAC或CD）； 2）使用此数据创建创新的个性化决策支持MHealth应用程序（先前的CD决策应用程序），该应用程序将值澄清练习与经过验证的VBAC预测工具集成在一起； 3）在1650名说英语或西班牙语的妇女中，对先前的CD决策应用程序进行随机试验，以评估其对TOLAC和VBAC率和决策质量的影响。我们的假设是，与仅接受常规护理的妇女相比，随机使用先前的CD决策应用程序的女性更有可能进行TOLAC并具有VBAC，并且会经历较少的决策冲突，对Tolac和Ercd和ERCD和ERCD和经验更加最佳的共享决策更加了解。