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临床试验/NCT03956810
NCT03956810已完成不适用

Evaluation of the Prenatal Trip Assistance Pilot Project

Ohio State University2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
2
主要终点
Satisfaction with transportation services: scale

研究概览

简要总结

The prenatal trip assistance project is a study comparing two methods of delivering transportation assistance to pregnant women living in communities with high rates of infant mortality. Franklin County, Ohio, home of the state's capital of Columbus, has one of the highest rates of infant mortality in the U.S. at 8.2 per 1,000 live births.There have been many advances in "smart" applications in transportation over the past 10 years. However, despite the fact that the vast majority of impoverished women have a mobile phone, the transportation providers currently used by the Medicaid managed care plans are low tech with no mobile alerts or two-way communication with the woman. The purpose of the proposed study is to examine the preliminary efficacy of providing expanded and "smart" transportation services to increase communications, reliability, and customer satisfaction and reduce adverse pregnancy outcomes among women whose children are at high risk of infant mortality. The investigators aim to enroll and randomize 500 eligible pregnant women to either on-demand services or usual transportation services as provided by their Medicaid managed care organization. The primary outcome for the proposed trial will be overall satisfaction with transportation services as assessed by the final study questionnaire (i.e., two months after delivery or miscarriage) and secondary outcome measures will include: adequacy of prenatal care, preterm birth and infant mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Willing to consent to communication by phone, text, and email
  • Access to a telephone (mobile or landline), tablet or computer
  • Pregnant & <32 weeks of gestation
  • Last menstrual period on or before 2/9/2020 or due by November 15, 2020
  • At least 18 years old
  • Enrolled in one of two Medicaid managed care organizations
  • Residence in Franklin County, Ohio
  • Ambulatory
  • English speaking

排除标准

  • No plans to move out of Franklin County prior to delivery
  • Able to read, understand, and communicate in English
  • Woman has not been previously enrolled in this study
  • Race/ethnicity stratum is not full
  • Willing to meet staff to be interviewed

结局指标

主要结局

Satisfaction with transportation services: scale

时间窗: Obtained 8 weeks postpartum

Participants will be asked in one question to rate their level of overall satisfaction with transportation services measured on a five-point scale (5=very satisfied, 1=Very dissatisfied). Those who rate their satisfaction as either somewhat (4) or very satisfied (5) will be considered satisfied with transportation services in analysis.

次要结局

  • Kotelchuck Adequacy of Prenatal Care Utilization index(Through study completion, an average of 9 months after enrollment.)
  • The proportion of deliveries < 37 weeks gestation(Through study completion, an average of 9 months after enrollment.)
  • The proportion of infants who die within one year of birth(One year post delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erinn Hade

Associate Professor

New York University

研究点 (2)

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