Evaluation of the Prenatal Trip Assistance Pilot Project

NCT ID: NCT03956810

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2022-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

On-demand transportation

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.

Group Type: EXPERIMENTAL

On-demand transportation

Intervention Type: OTHER

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

Usual transportation

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

Group Type: ACTIVE_COMPARATOR

Usual transportation

Intervention Type: OTHER

Usual transportation scheduling via call-center.

Interventions

On-demand transportation

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

Intervention Type: OTHER

Usual transportation

Usual transportation scheduling via call-center.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Erinn Hade

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erinn M Hade, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2019H0009

Identifier Type: -

Identifier Source: org_study_id