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Evaluation of the Prenatal Trip Assistance Pilot Project

Primary Purpose

Pregnancy Preterm, Infant Death

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
On-demand transportation
Usual transportation
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Preterm focused on measuring transportation; prenatal care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

On-demand transportation

Usual transportation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
The proportion of deliveries < 37 weeks gestation
The proportion of preterm deliveries occurring before 37 weeks gestation
The proportion of infants who die within one year of birth
Death of a live born infant within the first year of life

Full Information

First Posted
May 15, 2019
Last Updated
October 23, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03956810
Brief Title
Evaluation of the Prenatal Trip Assistance Pilot Project
Official Title
Evaluation of the Prenatal Trip Assistance Pilot Project
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Preterm, Infant Death
Keywords
transportation; prenatal care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
On-demand transportation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual transportation
Arm Type
Active Comparator
Arm Description
Women assigned to the usual care group will receive the usual transportation services from their Medicaid managed care organization.
Intervention Type
Other
Intervention Name(s)
On-demand transportation
Intervention Description
On-demand scheduling via telephone, web portal, or the broker's mobile application.
Intervention Type
Other
Intervention Name(s)
Usual transportation
Intervention Description
Usual transportation scheduling via call-center.
Primary Outcome Measure Information:
Title
Satisfaction with transportation services: scale
Description
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.
Time Frame
Obtained 8 weeks postpartum
Secondary Outcome Measure Information:
Title
Kotelchuck Adequacy of Prenatal Care Utilization index
Description
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).
Time Frame
Through study completion, an average of 9 months after enrollment.
Title
The proportion of deliveries < 37 weeks gestation
Description
The proportion of preterm deliveries occurring before 37 weeks gestation
Time Frame
Through study completion, an average of 9 months after enrollment.
Title
The proportion of infants who die within one year of birth
Description
Death of a live born infant within the first year of life
Time Frame
One year post delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erinn M Hade, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Prenatal Trip Assistance Pilot Project

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