- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956810
Evaluation of the Prenatal Trip Assistance Pilot Project
October 23, 2023 updated by: Erinn Hade, Ohio State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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On-demand scheduling via telephone, web portal, or the broker's mobile application.
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Active Comparator: Usual transportation
Women assigned to the usual care group will receive the usual transportation services from their Medicaid managed care organization.
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Usual transportation scheduling via call-center.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with transportation services: scale
Time Frame: Obtained 8 weeks postpartum
|
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.
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Obtained 8 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kotelchuck Adequacy of Prenatal Care Utilization index
Time Frame: Through 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).
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Through study completion, an average of 9 months after enrollment.
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The proportion of deliveries < 37 weeks gestation
Time Frame: Through study completion, an average of 9 months after enrollment.
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The proportion of preterm deliveries occurring before 37 weeks gestation
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Through study completion, an average of 9 months after enrollment.
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The proportion of infants who die within one year of birth
Time Frame: One year post delivery
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Death of a live born infant within the first year of life
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One year post delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erinn M Hade, PhD, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2019
Primary Completion (Actual)
January 15, 2021
Study Completion (Actual)
December 13, 2022
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
May 20, 2019
First Posted (Actual)
May 21, 2019
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 23, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019H0009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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