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Evaluation of the Prenatal Trip Assistance Pilot Project

Evaluation of the Prenatal Trip Assistance Pilot Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956810
Enrollment
143
Registered
2019-05-21
Start date
2019-05-31
Completion date
2022-12-13
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Death, Pregnancy Preterm

Keywords

transportation; prenatal care

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.

Interventions

OTHEROn-demand transportation

On-demand scheduling via telephone, web portal, or the broker's mobile application.

OTHERUsual transportation

Usual transportation scheduling via call-center.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction with transportation services: scaleObtained 8 weeks postpartumParticipants 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.

Secondary

MeasureTime frameDescription
Kotelchuck Adequacy of Prenatal Care Utilization indexThrough study completion, an average of 9 months after enrollment.The Adequacy of prenatal care utilization index, as defined by Kotelchuck (AJPH, 1994). This index utilizes information on: gestational age at entry to prenatal care, the number of prenatal care visits, and the gestational age at delivery (to determine an expected number of prenatal visits). The index includes two dimensions which are combined (adequacy of initiation of prenatal care and adequacy of received services) into a single summary prenatal care utilization index category (Adequate plus utilization, Adequate utilization, Intermediate utilization, Inadequate utilization).
The proportion of deliveries < 37 weeks gestationThrough study completion, an average of 9 months after enrollment.The proportion of preterm deliveries occurring before 37 weeks gestation
The proportion of infants who die within one year of birthOne year post deliveryDeath of a live born infant within the first year of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026