Pregnancy PretermNCT03956810
Evaluation of the Prenatal Trip Assistance Pilot Project
A study testing On-demand transportation and Usual transportation in people with Pregnancy Preterm and Infant Death, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Preterm, Infant Death
- What is being tested?
- On-demand transportation and Usual transportation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Residence in Franklin County, Ohio
- Ambulatory
- English speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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
- Being tested
- On-demand transportation, Usual transportation
- Keywords
- transportation; prenatal care
- Medical subject headings
- Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-demand transportationOther
On-demand scheduling via telephone, web portal, or the broker's mobile application.
Usual transportationOther
Usual transportation scheduling via call-center.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual transportation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Obtained 8 weeks postpartum
Secondary outcomes (3)
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).
Measured: Through study completion, an average of 9 months after enrollment.
The proportion of deliveries < 37 weeks gestation
The proportion of preterm deliveries occurring before 37 weeks gestation
Measured: Through study completion, an average of 9 months after enrollment.
The proportion of infants who die within one year of birth
Death of a live born infant within the first year of life
Measured: One year post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start31 May 2019
- Primary completion15 Jan 2021
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy PretermStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erinn Hade, New York University
- Investigators
- Erinn M Hade, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956810
- Sponsor's protocol ID
- 2019H0009
- Status last verified
- Oct 2023
- First submitted
- 15 May 2019
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prenatal Trip Assistance Pilot Project
- ClinicalTrials.gov ID
- NCT03956810
- Acronym / sponsor ID
- 2019H0009
- Conditions
- Pregnancy Preterm, Infant Death
- Keywords
- transportation; prenatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-demand transportation | Experimental | Other: On-demand transportationWomen 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. |
| Usual transportation | Active comparator | Other: Usual transportationWomen assigned to the usual care group will receive the usual transportation services from their Medicaid managed care organization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-demand transportationOn-demand scheduling via telephone, web portal, or the broker's mobile application. | Other | On-demand transportation |
| Usual transportationUsual transportation scheduling via call-center. | Other | Usual transportation |
Primary outcome
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.
3 secondary outcomes
Kotelchuck Adequacy of Prenatal Care Utilization index
Time frame: Through study completion, an average of 9 months after enrollment.
The proportion of deliveries < 37 weeks gestation
Time frame: Through study completion, an average of 9 months after enrollment.
The proportion of infants who die within one year of birth
Time frame: One year post delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erinn M Hade, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-demand transportation and Usual transportation in people with Pregnancy Preterm and Infant Death, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with transportation services: scale (time frame: Obtained 8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.