Clinical trial NCT03956810: Evaluation of the Prenatal Trip Assistance Pilot Project
Official title: Evaluation of the Prenatal Trip Assistance Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Preterm
Infant Death
Keywords: transportation; prenatal care
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Satisfaction with transportation services: scale
timeFrame: Obtained 8 weeks postpartum
Secondary outcomes:
measure: Kotelchuck Adequacy of Prenatal Care Utilization index
timeFrame: Through study completion, an average of 9 months after enrollment.
measure: The proportion of deliveries < 37 weeks gestation
timeFrame: Through study completion, an average of 9 months after enrollment.
measure: The proportion of infants who die within one year of birth
timeFrame: One year post delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Erinn M Hade, PhD
role: PRINCIPAL_INVESTIGATOR
References: