Evaluation of the Prenatal Trip Assistance Pilot Project

Pregnancy Preterm Clinical Trial

Official title:

Evaluation of the Prenatal Trip Assistance Pilot Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956810
• Other study ID #: 2019H0009
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: December 13, 2022

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 13, 2022
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infant Death
• Pregnancy Preterm

Intervention

Other:
• On-demand transportation
On-demand scheduling via telephone, web portal, or the broker's mobile application.
• Usual transportation
Usual transportation scheduling via call-center.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with transportation services: scale	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.	Obtained 8 weeks postpartum
Secondary	Kotelchuck Adequacy of Prenatal Care Utilization index	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).	Through study completion, an average of 9 months after enrollment.
Secondary	The proportion of deliveries < 37 weeks gestation	The proportion of preterm deliveries occurring before 37 weeks gestation	Through study completion, an average of 9 months after enrollment.
Secondary	The proportion of infants who die within one year of birth	Death of a live born infant within the first year of life	One year post delivery