Clinical trial NCT02987803: Helping Mothers Select Better Childbirth Hospitals
Official title: Helping Mothers Select Better Childbirth Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Patient Engagement
Public Reporting
Quality Measurement
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2016-12-09
Enrollment: 120621
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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%.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hospital Selection
timeFrame: Up to 12 months
Secondary outcomes:
measure: Knowledge of Hospital-Level Differences
timeFrame: Up to 12 months
measure: Hospital Impact on Cesarean Delivery Risk
timeFrame: Up to 12 months
measure: Use of Rates in Hospital Selection
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Ateev Mehrotra, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Neel Shah, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
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.