The Impact of Virtual Doula Services on Birth Outcomes in Rural Communities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- RAND
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Birth type
研究概览
简要总结
This study will assess the impact of virtual doula care on birth and postnatal outcomes among rural mothers. The goal of virtual doula services is to improve access to care in underserved communities and decrease urban-rural differences in key maternal health outcomes including mode of birth (cesarean vs vaginal) and birth satisfaction. By implementing a digital randomized controlled trial, the study team will efficiently recruit a national sample of rural pregnant women to provide evidence of the effectiveness of virtual doula care, the appropriateness of virtual visits for different care and support needs, and the role of virtual care in improving maternal health.
详细描述
Rates of maternal morbidity have been rising in the U.S., and there are stark rural-urban differences in cesarean births and adverse pregnancy outcomes. Increasing access to doula care is a promising strategy to improve maternal health. Doulas are non-clinical providers who offer physical, emotional, and informational support throughout the perinatal period. Yet, despite documented evidence of effectiveness, fewer than 10% of U.S. births involve doulas because of costs and workforce shortages. Virtual doula services may increase access to support in communities that lack doulas and decrease costs; however, there is minimal evidence of the effectiveness of this new care model. Lack of research in general, and randomized controlled trials in particular, represents a significant gap given that virtual doula services are currently offered by numerous organizations, and the states and payers adding doula benefits do not have evidence to inform their telehealth policies.
The study team will conduct an innovative digital, parallel design randomized controlled trial (RCT) to assess the impact of virtual doula services in rural communities. Primiparous, pregnant women who live in rural zip codes in the U.S. will be recruited. Recruitment will occur via online research panels. Participants will be randomized to scheduled visits with virtual doulas throughout the perinatal period or to usual care. Birth and postnatal outcomes will be captured via surveys and interviews. This study uses mixed methods and aims to assess the impact of virtual doula services on primary outcomes including type of birth (cesarean vs vaginal), birth satisfaction, and parental self-efficacy and secondary outcomes including maternal depression, breastfeeding initiation and duration, and receipt of prenatal and postnatal care. This study will also explore the acceptability of virtual care for different types of doula visits. Together, these aims will inform policy debates about regulation and reimbursement of doula services that incorporate virtual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years of age
- •pregnant (second or early third trimester) with their first child
- •reside in a rural zip codes in the U.S.
排除标准
- •non-singleton pregnancy
- •police custody or incarceration
- •infant to be separated from mother (e.g., placed for adoption, protective custody)
- •working with a doula prior to enrollment.
研究组 & 干预措施
Active Comparator Arm
This arm will receive a free ebook on parenting. The care that they receive for pregnancy and birth will be care as usual.
干预措施: Ebook (Other)
Virtual Doula Support
This arm will receive up to 4 scheduled visits with doulas via a mobile phone app. Visits can be used any time throughout the perinatal period, including postpartum.
干预措施: Virtual doula support (Other)
结局指标
主要结局
Birth type
时间窗: Assessed at 3 weeks postpartum
Cesarean or Vaginal Birth
Birth Satisfaction
时间窗: Assessed at 3 weeks postpartum
Score on Birth Satisfaction Scale-Revised. Scores can range from 0-40, with higher scores indicating greater satisfaction.
Parental Self-Efficacy
时间窗: Assessed at 12 weeks postpartum
Score on maternal confidence questionnaire. Scores can range from 14 to 70, with higher scores indicating greater maternal confidence.
Birth type
时间窗: Assessed at 3 weeks postpartum
Cesarean or Vaginal Birth
Birth Satisfaction
时间窗: Assessed at 3 weeks postpartum
Score on Birth Satisfaction Scale-Revised. Scores can range from 0-40, with higher scores indicating greater satisfaction.
Parental Self-Efficacy
时间窗: Assessed at 12 weeks postpartum
Score on maternal confidence questionnaire. Scores can range from 14 to 70, with higher scores indicating greater maternal confidence.
次要结局
- Maternal Depression(Assessed at 3 weeks postpartum)
- Breastfeeding duration(Assessed at 12 weeks postpartum)
- Receipt of postnatal care(Assessed at 12 weeks postpartum)
- Birth Truma(Assessed at 3 weeks postpartum)
- Breastfeeding Initiation(Assessed at 12 weeks postpartum)
- Birth Truma(Assessed at 3 weeks postpartum)
- Maternal Depression(Assessed at 3 weeks postpartum)
- Breastfeeding duration(Assessed at 12 weeks postpartum)
- Receipt of postnatal care(Assessed at 12 weeks postpartum)
- Breastfeeding Initiation(Assessed at 12 weeks postpartum)