Scaling up Maternal Health Equity Best Practices

NCT ID: NCT06541951

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2030-11-30

Brief Summary

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

Detailed Description

The project recruits prenatal and postnatal care providers in 12 Michigan counties. his project will develop and test a scale-up focused implementation approach for addressing pregnancy-related and -associated morbidity and mortality (PRAMM) disparities. Previous efforts have shown that use of hospital- focused maternal safety bundles are an important part of successful efforts to reduce PRAMM. However, overall quality of obstetric care improved in these efforts without any effect on disparities. Thus, unlike previous efforts, the proposed project will implement quality improvement bundles that: (1) focus on PRAMM disparities; and (2) focus on community care (i.e., care provided outside the hospital in outpatient and other community settings) and coordination among care settings. Given that 83% of U.S. pregnancy-related and pregnancy-associated deaths occur during pregnancy or postpartum (rather than around the time of delivery), outpatient and community efforts are vital. Bundles (the evidence-based practices to be implemented) are developed by the national Alliance for Innovation on Maternal Health Community Care Initiative (AIM-CCI), and include "Community care for postpartum safety and wellness," and "Community care for maternal mental health," "Chronic conditions," and "Intimate partner violence" bundles. All bundles target PRAMM disparities. • Aim 1 of the proposed project will analyze bundle implementation experiences in 2 counties to develop a county-wide scale-up focused implementation approach for the bundles in partnership with stakeholders date to create and manualize a scale-up implementation intervention. • Aim 2 will evaluate the effectiveness and cost-effectiveness of the scale-up implementation intervention using a stepped wedge design in 12 Michigan counties with a total population of nearly 6 million people. PRAMM outcomes (individual level) will be extracted from a pre-existing statewide linked dataset. The sample for these analyses will include all Medicaid insured individuals in the 12 counties observed during pregnancy, at birth, and up to 1 year postpartum during the project period (~151,920 births, including ~49,110 births to African American and/or Hispanic mothers). Implementation outcomes (provider-level) include scale-up (penetration, reach, control for delivery, and intervention effectiveness at scale) and sustainment (maintenance of fidelity to core elements, health benefits, and capacity to deliver core elements over time). This project is innovative because it: (1) is the first controlled implementation trial to test approaches to implementing quality improvement bundles that: (a) specifically target PRAMM disparities; and (b) focus on community care; (2) advances the science of scale-up (it is the first study to test scale- up or sustainment implementation approaches to addressing maternal morbidity/mortality disparities); and (3) works to improve services across many (vs. a single) health systems. The project is significant because the field needs to reach pregnant people at scale, and scale-up is an understudied aspect of implementation science.

Conditions

Maternal Mortality Disparities; Maternal Morbidity Disparities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Services as usual

Services as usual before maternal health equity implementation efforts

Group Type: ACTIVE_COMPARATOR

Services as usual

Intervention Type: OTHER

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

Scale-up implementation approach

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

Group Type: EXPERIMENTAL

Scale-up implementation approach

Intervention Type: 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.

Interventions

Services as usual

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

Intervention Type: OTHER

Scale-up implementation approach

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-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.

-All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan

Exclusion Criteria

• None

Patient outcomes are assessed through population-level Medicaid data, without direct recruitment.

-None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer E. Johnson

Chair, Charles Stewart Mott Department of Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer E. Johnson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Jaye Clement, MPH, MPP

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Amy Loree, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Locations

Michigan State University on behalf on 12 Michigan counties

Flint, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Simran Dhaliwal Project Coordinator

Role: CONTACT

MHMiracle@Msu.edu

810-600-5630

Facility Contacts

Jennifer Johnson, PhD

Role: primary

jjohns@msu.edu

810-600-5669

Amy Loree, PhD

Role: backup

aloree1@hfhs.org

313-874-5452

References

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.

Reference Type: DERIVED

PMID: 39980059 (View on PubMed)

Other Identifiers

U54HD113291

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009307

Identifier Type: -

Identifier Source: org_study_id