Scaling up Maternal Health Equity Best Practices

Michigan State University

Status: Enrolling

Conditions: Maternal Mortality Disparities; Maternal Morbidity Disparities

Treatments: Other: Services as usual; Other: Scale-up implementation approach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06541951

STUDY00009307

U54HD113291 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Provider 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.

Provider Exclusion Criteria:

• None

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

Patient Inclusion criteria:

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

Patient Exclusion criteria:

-None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Services as usual

Active Comparator group

Description:

Services as usual before maternal health equity implementation efforts

Treatment:

Other: Services as usual

Scale-up implementation approach

Experimental group

Description:

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

Treatment:

Other: Scale-up implementation approach