Scaling up Maternal Health Equity Best Practices

NCT06541951 | Recruiting

• 2 other identifiers: STUDY00009307U54HD113291
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study works with prenatal and postnatal care providers in 12 Michigan counties to scale up best practices for maternal health equity.

Conditions

Maternal Mortality Disparities; Maternal Morbidity Disparities

Keywords

health inequities; maternal health; maternal mortality; implementation science; healthcare disparities; African Americans; Hispanic

Outcome Measures

Primary Outcomes (1)

• African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM)

  A composite variable reflecting all pregnancy-related and associated morbidity and mortality conditions from pregnancy through 12 months postpartum, assessed using Medicaid claims data. The investigators will assess overall rates for African-American/Hispanic people and their rates relative to non-Hispanic white ones.

  Continuous for 6 years

Secondary Outcomes (10)

• Scale-up: Penetration

  Assessed annually for 6 years

• Scale-up: Reach

  Assessed annually for 6 years

• Scale-up: Control for delivery

  Assessed annually for 6 years

• Scale-up: Effectiveness

  Assessed annually for 6 years

• Sustainment: Fidelity

  Annually for 6 years

Study Arms (2)

Services as usual

ACTIVE COMPARATOR

Services as usual before maternal health equity implementation efforts

Other: Services as usual

Scale-up implementation approach

EXPERIMENTAL

An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners.

Other: Scale-up implementation approach

Interventions

Services as usual OTHER

During this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures

Services as usual

Scale-up implementation approach OTHER

An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners. It may involve implementation approaches such as training, facilitation, learning collaboratives, coalitions, and other activities.

Scale-up implementation approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a provider or staff person at agencies offering prenatal and/or postnatal services in Wayne, Oakland, Ingham, Isabella, Macomb, Muskegon, Calhoun, Jackson, Saginaw, Kalamazoo, Barrien, or Washtenaw counties in Michigan.

You may not qualify if:

• None
• Patient outcomes are assessed through population-level Medicaid data, without direct recruitment.
• All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan
• None

Sponsors & Collaborators

• Michigan State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Michigan State University on behalf on 12 Michigan counties

Flint, Michigan, 48503-4684, United States

RECRUITING

Related Publications (1)

• Johnson JE, Clement J, Sikorskii A, Loree A, Meulen MV, Roman L, Dearing JW, Bolder H, White JM, Sokol R, Meghea C. A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol. Implement Sci Commun. 2025 Feb 20;6(1):19. doi: 10.1186/s43058-024-00677-7.

  PMID: 39980059 DERIVED

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer E. Johnson, Ph.D.

  Michigan State University

  PRINCIPAL INVESTIGATOR

• Jaye Clement, MPH, MPP

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

• Amy Loree, PhD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simran Dhaliwal Project Coordinator

CONTACT

810-600-5630; MHMiracle@Msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Charles Stewart Mott Department of Public Health

Model Details: Cluster-randomized stepped wedge design

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 7, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)