NCT02987803

Brief Summary

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120,621

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
2.7 years until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

November 17, 2016

Last Update Submit

October 28, 2021

Conditions

Cesarean Section

Keywords

Patient EngagementPublic ReportingQuality Measurement

Outcome Measures

Primary Outcomes (1)

  • Hospital Selection

    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.

    Up to 12 months

Secondary Outcomes (3)

  • Knowledge of Hospital-Level Differences

    Up to 12 months

  • Hospital Impact on Cesarean Delivery Risk

    Up to 12 months

  • Use of Rates in Hospital Selection

    Up to 12 months

Study Arms (2)

Control Group

NO INTERVENTION

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.

Data Group

EXPERIMENTAL

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.

Other: Data

Interventions

DataOTHER

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.

Data Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Public Health

Boston, Massachusetts, 02110, United States

Location

Related Publications (1)

  • 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.

    PMID: 36217115DERIVED

Related Links

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ateev Mehrotra, MD, MPH

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

  • Neel Shah, MD, MPP

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2016

First Posted

December 9, 2016

Study Start

August 15, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)