Better Birth Outcomes Through Technology, Education, and Reporting
NCT ID: NCT06261398
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
550 participants
INTERVENTIONAL
2024-02-26
2028-03-31
Brief Summary
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Detailed Description
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This study will expand our understanding of addressing SDoH, including linkage to services that mitigate SDoH. This information can inform future interventions that address SDoH. Creating new tools to address the needs and strengths of obstetric patients, and encouraging their use, will improve the management of patient care during and after pregnancy.
The patient sample will include obstetric patients receiving care at the OSUWMC McCampbell OB/GYN clinic or the OSUWMC Outpatient Care East OB/GYN clinic. A total of 550 patients will participate in the study and be randomly assigned to either the intervention or control group. We will collect maternal and child health outcome data using patient electronic health records and surveys.
At the time of randomization at the patient's prenatal appointment, a researcher will use a survey to collect participant baseline data, including patient demographics and patient-reported outcomes. This information will be collected again during a study visit during the patient's prenatal appointment when the patient is 28-32 weeks gestation.
Final data collection from patient records will occur after delivery (for both intervention and control groups). Research staff will extract information from patients' and their baby's medical records, including maternal and perinatal outcomes.
The intervention includes one motivational interviewing session that encourages the patient to address their social needs. Following the intervention, patients will receive bi-weekly text messages with links to help them address social needs; these links are: (1) to a patient portal to enable them connect with their care team, (2) to Health Impact Ohio, a local organization that can help patients address social needs; and (3) to "findhelp.org," a site that can provide a list of resources based on zip code.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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BETTER Intervention
Patients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs.
BETTER: motivational interviewing and text messaging
Motivational interviewing to encourage individuals to address their social needs and engage with text messages that allow individuals to connect to their care team, a local organization that can help them address their social needs, and/or a resource that enables them to find help to address their needs based on their zip code.
Standard of care
No motivational interviewing or text messages will be provided.
Standard of care
No motivational interviewing or text messages will be provided.
Interventions
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BETTER: motivational interviewing and text messaging
Motivational interviewing to encourage individuals to address their social needs and engage with text messages that allow individuals to connect to their care team, a local organization that can help them address their social needs, and/or a resource that enables them to find help to address their needs based on their zip code.
Standard of care
No motivational interviewing or text messages will be provided.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East
* Singleton pregnancy and fetus with a heartbeat
* English speaking
* Able to receive text messages
Exclusion Criteria
* Has a plan for transfusion during pregnancy
18 Years
FEMALE
No
Sponsors
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American Heart Association
OTHER
Ohio State University
OTHER
Responsible Party
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Ann McAlearney
Professor of Family Medicine and Executive Director, CATALYST
Principal Investigators
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William Grobman, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Ann McAlearney, ScD, MS
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Outpatient Care East
Columbus, Ohio, United States
McCampbell Hall
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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McAlearney AS, MacEwan SR, Huerta TR, Thomas NR, Sova LN, Roth L, Bartholomew A, Rush LJ, Johnson KF, Grobman WA. Patient-informed outpatient intervention to improve pregnancy outcomes through connections to social services: protocol for the BETTER randomised controlled trial. BMJ Open. 2025 Jun 18;15(6):e096119. doi: 10.1136/bmjopen-2024-096119.
Other Identifiers
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2023H0065
Identifier Type: -
Identifier Source: org_study_id
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