Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-03-05 @ 7:58 PM
Study NCT ID:
NCT02987803
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2016-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helping Mothers Select Better Childbirth Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120621}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Selection', 'timeFrame': 'Up to 12 months', 'description': 'Enrollees will be asked to self-report the hospital where they delivered. Hospitals will be categorized into a five-star quality rating scale based on the corresponding quintile of their cesarean section rate at the state level, as reported to the Leapfrog Group and other state data sources. Our primary outcome will be the average star rating of hospitals selected by control and intervention group enrollees. We will also report the proportion of enrollees in each group selecting hospitals of each star rating, as well as selecting hospitals that do not report their cesarean section rate.'}], 'secondaryOutcomes': [{'measure': 'Knowledge of Hospital-Level Differences', 'timeFrame': 'Up to 12 months', 'description': "Participants' response to a survey question about thinking there are differences in cesarean delivery rates between hospitals in their community"}, {'measure': 'Hospital Impact on Cesarean Delivery Risk', 'timeFrame': 'Up to 12 months', 'description': "Participants' response to a survey question about thinking the hospital they choose will impact their chances of having a cesarean delivery"}, {'measure': 'Use of Rates in Hospital Selection', 'timeFrame': 'Up to 12 months', 'description': "Participants' response to a survey question about looking at cesarean delivery rates when choosing their childbirth hospital"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Engagement', 'Public Reporting', 'Quality Measurement'], 'conditions': ['Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '36217115', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.ariadnelabs.org/', 'label': 'Ariadne Labs'}, {'url': 'https://www.oviahealth.com', 'label': 'Ovia Health'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to conduct a randomized controlled trial of women who are pregnant or considering pregnancy to understand whether women provided with specific data on hospital-level cesarean delivery rates are more likely to select higher quality hospitals, defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020 target of 23.9%.', 'detailedDescription': 'The choice of a childbirth provider is one of the most consequential decisions a pregnant woman makes. The hospital she delivers at is a better predictor of many treatment decisions than her own risks or preferences. For example, choosing the wrong hospital can increase the risk of cesarean delivery up to 10-fold. Cumulatively, avoidable cesarean deliveries are estimated to cause 20,000 major surgical complications, $5 billion in spending, and unmeasured pain each year in the United States.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ovia Fertility users that are trying to conceive and are not infertile or Ovia Pregnancy users within the United States in their first trimester who have NOT chosen a delivery hospital or provider.\n\nExclusion Criteria:\n\n* People who do not use Ovia Health mobile applications, Ovia Pregnancy users beyond the first trimester of their pregnancy, Ovia Fertility users that are not infertile (as defined by women under 35 that have been trying for more than 12 months, and women over 35 that have been trying for over 6 months) and Ovia Pregnancy/Fertility users who have selected their delivering hospital or provider.'}, 'identificationModule': {'nctId': 'NCT02987803', 'briefTitle': 'Helping Mothers Select Better Childbirth Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Helping Mothers Select Better Childbirth Hospitals', 'orgStudyIdInfo': {'id': 'IRB16-1371'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Data Group', 'description': '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.\n\nParticipants will not know they are participating in a trial.', 'interventionNames': ['Other: Data']}], 'interventions': [{'name': 'Data', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Data Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02110', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard School of Public Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ateev Mehrotra, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}, {'name': 'Neel Shah, MD, MPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Neel Shah', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}