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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COMPLETED
NA
120621 participants
INTERVENTIONAL
2019-08-15
2021-06-30
Brief Summary
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Detailed Description
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The proposed project aims to prevent these harms by empowering women to choose hospitals with risk-appropriate cesarean delivery rates. Preliminary research indicates that the majority of women may not understand how hospital-level quality data applies to them personally. In a test sample of 1,000 demographically diverse pregnant mothers, over half do not know if hospital-level cesarean delivery rates are important, and the overwhelming majority do not know if obstetrical infection rates, maternal or neonatal birth trauma rates, or hospital quality metrics are important when selecting their hospital. The investigators will conduct a randomized controlled trial of women using Ovia Health mobile applications to track their fertility or pregnancy to understand whether women provided with location-specific cesarean delivery rate data along with education about the importance of hospital-level cesarean delivery rates are more likely to select higher quality hospitals than women provided with education alone.
The study is labeled double blind, but the investigators recognize uncertainty on this framework. Though subjects will be exposed to different information they do not know they were in a trial. At the point that outcomes are collected, researchers will not know which group the subject was randomized because outcomes are self-reported.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Control Group
Participants in the control group will receive educational articles about obstetric hospitals. The articles will prompt the participant to look up hospitals in their geographic location. Participants will not know they are participating in a trial.
No interventions assigned to this group
Data Group
Participants in the intervention group will receive an educational module designed to support them in selecting a delivering hospital, which will include an educational video, articles, and a data tool with cesarean delivery rate data for hospitals in their geographic location.
Participants will not know they are participating in a trial.
Data
The tool displays star ratings of hospitals on how labor-friendly they are. The star ratings (1 through 5) are based on hospital-level cesarean delivery rates. The data comes from The Leapfrog Group and is supplemented by publicly available state data. The data displayed will be customized to the users geographic location.
Interventions
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Data
The tool displays star ratings of hospitals on how labor-friendly they are. The star ratings (1 through 5) are based on hospital-level cesarean delivery rates. The data comes from The Leapfrog Group and is supplemented by publicly available state data. The data displayed will be customized to the users geographic location.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Neel Shah
Principal Investigator
Principal Investigators
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Ateev Mehrotra, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Neel Shah, MD, MPP
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Harvard School of Public Health
Boston, Massachusetts, United States
Countries
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References
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Mehrotra A, Wolfberg A, Shah NT, Plough A, Weiseth A, Blaine AI, Noddin K, Nakamoto CH, Richard JV, Bradley D. Impact of an educational program and decision tool on choice of maternity hospital: the delivery decisions randomized clinical trial. BMC Pregnancy Childbirth. 2022 Oct 10;22(1):759. doi: 10.1186/s12884-022-05087-y.
Related Links
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Ariadne Labs
Ovia Health
Other Identifiers
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IRB16-1371
Identifier Type: -
Identifier Source: org_study_id