Evaluation of the Prenatal Trip Assistance Pilot Project

NCT03956810 | Completed DMC

• 1 other identifier: 2019H0009
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Preterm; Infant Death

Keywords

transportation; prenatal care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

On-demand transportation

EXPERIMENTAL

Women randomized to the intervention group will be able to contact the transportation broker via telephone, web portal, or the broker's mobile application. In addition to the current trips provided by their Medicaid managed care organization , women assigned to the intervention group will be provided with extra trips to the pharmacy and grocery store or food bank.

Other: On-demand transportation

Usual transportation

ACTIVE COMPARATOR

Women assigned to the usual care group will receive the usual transportation services from their Medicaid managed care organization.

Other: Usual transportation

Interventions

On-demand transportation OTHER

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

On-demand transportation

Usual transportation OTHER

Usual transportation scheduling via call-center.

Usual transportation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Infant Death

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erinn M Hade, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 21, 2019
• Study Start: May 31, 2019
• Primary Completion: January 15, 2021
• Study Completion: December 13, 2022
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)