<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02987803</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-1371</org_study_id>
    <nct_id>NCT02987803</nct_id>
  </id_info>
  <brief_title>Helping Mothers Select Better Childbirth Hospitals</brief_title>
  <official_title>Helping Mothers Select Better Childbirth Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to conduct a randomized controlled trial of women who are pregnant or&#xD;
      considering pregnancy to understand whether women provided with specific data on&#xD;
      hospital-level cesarean delivery rates are more likely to select higher quality hospitals,&#xD;
      defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020 target&#xD;
      of 23.9%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The choice of a childbirth provider is one of the most consequential decisions a pregnant&#xD;
      woman makes. The hospital she delivers at is a better predictor of many treatment decisions&#xD;
      than her own risks or preferences. For example, choosing the wrong hospital can increase the&#xD;
      risk of cesarean delivery up to 10-fold. Cumulatively, avoidable cesarean deliveries are&#xD;
      estimated to cause 20,000 major surgical complications, $5 billion in spending, and&#xD;
      unmeasured pain each year in the United States.&#xD;
&#xD;
      The proposed project aims to prevent these harms by empowering women to choose hospitals with&#xD;
      risk-appropriate cesarean delivery rates. Preliminary research indicates that the majority of&#xD;
      women may not understand how hospital-level quality data applies to them personally. In a&#xD;
      test sample of 1,000 demographically diverse pregnant mothers, over half do not know if&#xD;
      hospital-level cesarean delivery rates are important, and the overwhelming majority do not&#xD;
      know if obstetrical infection rates, maternal or neonatal birth trauma rates, or hospital&#xD;
      quality metrics are important when selecting their hospital. The investigators will conduct a&#xD;
      randomized controlled trial of women using Ovia Health mobile applications to track their&#xD;
      fertility or pregnancy to understand whether women provided with location-specific cesarean&#xD;
      delivery rate data along with education about the importance of hospital-level cesarean&#xD;
      delivery rates are more likely to select higher quality hospitals than women provided with&#xD;
      education alone.&#xD;
&#xD;
      The study is labeled double blind, but the investigators recognize uncertainty on this&#xD;
      framework. Though subjects will be exposed to different information they do not know they&#xD;
      were in a trial. At the point that outcomes are collected, researchers will not know which&#xD;
      group the subject was randomized because outcomes are self-reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Selection</measure>
    <time_frame>Up to 12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Hospital-Level Differences</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Participants' response to a survey question about thinking there are differences in cesarean delivery rates between hospitals in their community</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Impact on Cesarean Delivery Risk</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Participants' response to a survey question about thinking the hospital they choose will impact their chances of having a cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Rates in Hospital Selection</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Participants' response to a survey question about looking at cesarean delivery rates when choosing their childbirth hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120621</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Data Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Participants will not know they are participating in a trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data</intervention_name>
    <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.</description>
    <arm_group_label>Data Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ovia Fertility users that are trying to conceive and are not infertile or Ovia&#xD;
             Pregnancy users within the United States in their first trimester who have NOT chosen&#xD;
             a delivery hospital or provider.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who do not use Ovia Health mobile applications, Ovia Pregnancy users beyond the&#xD;
             first trimester of their pregnancy, Ovia Fertility users that are not infertile (as&#xD;
             defined by women under 35 that have been trying for more than 12 months, and women&#xD;
             over 35 that have been trying for over 6 months) and Ovia Pregnancy/Fertility users&#xD;
             who have selected their delivering hospital or provider.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ateev Mehrotra, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard Medical School (HMS and HSDM)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neel Shah, MD, MPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harvard School of Public Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ariadnelabs.org/</url>
    <description>Ariadne Labs</description>
  </link>
  <link>
    <url>https://www.oviahealth.com</url>
    <description>Ovia Health</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>October 28, 2021</last_update_submitted>
  <last_update_submitted_qc>October 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Neel Shah</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Patient Engagement</keyword>
  <keyword>Public Reporting</keyword>
  <keyword>Quality Measurement</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987803
org study id: IRB16-1371
nct id: NCT02987803
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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%.
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.

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Hospital Selection
time frame: 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.
measure: Knowledge of Hospital-Level Differences
time frame: 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
time frame: 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
time frame: Up to 12 months
description: Participants' response to a survey question about looking at cesarean delivery rates when choosing their childbirth hospital
arm group label: Control Group
arm group type: No Intervention
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.
arm group label: Data Group
arm group type: Experimental
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.
Participants will not know they are participating in a trial.
intervention type: Other
intervention name: Data
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.
arm group label: Data Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ateev Mehrotra, MD, MPH
role: Principal Investigator
affiliation: Harvard Medical School (HMS and HSDM)
last name: Neel Shah, MD, MPP
role: Principal Investigator
affiliation: Harvard School of Public Health (HSPH)
facility: 
country: United States
url: https://www.ariadnelabs.org/
description: Ariadne Labs
url: https://www.oviahealth.com
description: Ovia Health
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Neel Shah
investigator title: Principal Investigator
sharing ipd: No