Severe Maternal MorbidityNCT05678699
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
A study testing Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) and Doula in people with Severe Maternal Morbidity and Maternal Death, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this study is to learn about the effects of Medicaid policy interventions on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are: 1. What is the effect of Medicaid healthcare quality interventions on SMM? 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Severe Maternal Morbidity, Maternal Death
- What is being tested?
- Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) and Doula
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant and postpartum Medicaid beneficiaries across the US
- Qualitative:
- Medicaid beneficiaries who identify as being at risk for poor outcomes or live in PA Health Equity Zones
- Doulas who provide care to Medicaid beneficiaries in Pennsylvania
- Medicaid Managed Care Organization (MCO) administrators in Pennsylvania. Severe maternal morbidity and mortality outcomes will be assessed in healthcare records and for these quantitative outcomes, patients will not be recruited individually
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh School of Public Health
Pittsburgh, Pennsylvania, 15261
Dara D Mendez, PhD, 4126485664, ddm11@pitt.edu
Marquita Smalls, MPH, 4123830574, mns69@pitt.edu
About this study
The goal of this study is to learn about the effects of Medicaid policy interventions on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are:
- What is the effect of Medicaid healthcare quality interventions on SMM?
- What is the effect of Medicaid healthcare quality interventions + doula care?
- What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services?
Participants will be asked to describe experiences as a result of Medicaid policy interventions and focused Medicaid policies.
- Conditions
- Severe Maternal Morbidity, Maternal Death
- Being tested
- Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment), Doula, Standard Care
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment)Behavioural
This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2.
- incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes.
DoulaBehavioural
This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2.
- Incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes.
- care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania.
Standard CareBehavioural
Participants receive standard care without quality interventions or doula care
| Study group | Role | What they receive |
|---|---|---|
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only | Other | The investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates will decline among populations at risk after the interventions (incentive payment and obstetric bundled payment) within Pennsylvania (PA); and H2: SMM will decline among those exposed to the interventions in PA, relative to those in similar states. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare interventions on beneficiaries' experiences. Receives: Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment); Behavioral: Standard Care |
| Doula Only | Other | The investigators will test two hypotheses: H1: SMM rates will decline among populations at risk after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: SMM will decline more among those exposed to both healthcare quality and doula care interventions in PA, relative to states implementing doula care only. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare and service interventions on beneficiaries' experiences. Receives: Behavioral: Doula; Behavioral: Standard Care |
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula | Other | Not described Receives: Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment); Behavioral: Doula; Behavioral: Standard Care |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe maternal morbidity (SMM)
SMM rate based on the Centers for Disease Control algorithm
Measured: 20 weeks gestation through 42 days postpartum
Secondary outcomes (4)
All cause mortality
Binary indicator of mortality based on Social Security Administration records
Measured: Delivery date through one year after delivery
Follow up for chronic conditions
Percent of persons who receive guideline concordant care for depression, substance use disorders, immunizations, and screening and referral for social determinants of health
Measured: 43 days through 1 year after delivery
Provision of evidence care in pregnancy and postpartum
Percent of Medicaid patients among each provider who receive screening and follow up for depression, treatment for substance use disorders, perinatal immunizations, and screening and referral for social determinants of health
Measured: During pregnancy and postpartum up to 1 year
Medicaid managed care administrator perspectives on policy interventions
Qualitative self report of perspectives
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start3 Jan 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Maternal MorbidityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Evaluation of policy interventions at the state level comparing within state and across states over time.
- Masking
- None (open label)
- Enrolment
- 10,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Dara Mendez, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678699
- Sponsor's protocol ID
- STUDY22080184
- Other IDs
- 1R01NR020670-01
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No