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Medicaid Interventions + Doula Care for Maternal Health

N/A

Recruiting

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up years 2, 3, and 4

Awards & highlights

Study Summary

This trial explores how healthcare quality interventions and doula care can affect maternal health by observing participants' experiences with Medicaid policy changes. #maternalhealthcare

Who is the study for?

This trial is for Black Medicaid beneficiaries in PA Health Equity Zones, doulas caring for them, and Medicaid MCO administrators in Pennsylvania. It's also open to pregnant and postpartum Medicaid beneficiaries across the US. The study will use healthcare records to assess severe maternal morbidity and mortality outcomes.Check my eligibility

What is being tested?

The study examines the impact of equity-focused Medicaid policies on severe maternal morbidity (SMM) and mortality. It compares standard care with two interventions: quality interventions alone, or combined with doula care. Participants' experiences with these services are also evaluated.See study design

What are the potential side effects?

Since this trial focuses on policy intervention rather than medical treatment, it does not involve typical medication side effects. However, participants may experience changes in their healthcare service satisfaction or access due to the new policies being tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Severe maternal morbidity (SMM)

Secondary outcome measures

All cause mortality

Follow up for chronic conditions

Medicaid managed care administrator perspectives on policy interventions

+1 more

Other outcome measures

Assess the changes in effects of the Medicaid healthcare quality interventions on beneficiaries' experiences

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) OnlyExperimental Treatment2 Interventions

The investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates among Black people will decline after the interventions (equity payment and obstetric bundled payment), relative to people of other race groups within Pennsylvania (PA); and H2: Racial inequities in 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.

Group II: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) + DoulaExperimental Treatment3 Interventions

Group III: Doula OnlyExperimental Treatment2 Interventions

The investigators will test two hypotheses: H1: SMM rates among Black people will decline more after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: Racial inequities in 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.

Group IV: Standard CareActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doula

2001

N/A

~480

Standard Care

2018

Completed Phase 4

~3720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

6,342,946 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

376,561 Total Patients Enrolled

Media Library

Standard Care Clinical Trial Eligibility Overview. Trial Name: NCT05678699 — N/A

Maternal Morbidity Research Study Groups: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) Only, Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) + Doula, Standard Care, Doula Only

Maternal Morbidity Clinical Trial 2023: Standard Care Highlights & Side Effects. Trial Name: NCT05678699 — N/A

Standard Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678699 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research initiative still open?

"The medical study can be found on clinicaltrials.gov and is recruiting patients; the trial was initially posted on March 1st 2023 with its last update occurring April 14th of this year."

Answered by AI

What is the magnitude of participants that have signed up for this research?

"Indeed, the information on clinicaltrials.gov reveals that this research initiative is seeking volunteers. This trial was first published on March 1st 2023 and has been recently updated April 14th of the same year. 10000000 people are being accepted from a single site for enrolment in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity

Dara Mendez 2023. "The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05678699.