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NCT Number: NCT06541951

Scaling up Maternal Health Equity Best Practices

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Services as Usual

Other

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

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.

Primary outcomes

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

    Time frame: Continuous for 6 years

    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.

Secondary outcomes

  1. Scale-up: Penetration

    Time frame: Assessed annually for 6 years

    Penetration (% providers/staff using recommended maternal health equity practices)

  2. Scale-up: Reach

    Time frame: Assessed annually for 6 years

    Number of perinatal people receiving recommended practices

  3. Scale-up: Control for delivery

    Time frame: Assessed annually for 6 years

    The degree to which control for delivery shifts to local actors and the practices are embedded in local delivery systems

  4. Scale-up: Effectiveness

    Time frame: Assessed annually for 6 years

    Effectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses.

  5. Sustainment: Fidelity

    Time frame: Annually for 6 years

    Fidelity to core elements at each time point as assessed through provider behavior assessed using a self-reported y/n responses to a checklist of activities

  6. Sustainment: Health benefits

    Time frame: Annually for 6 years

    Health benefits continuing over time: Operationalized as the slope of PRAMM annually after the county moves into the "intervention phase of the stepped wedge design

  7. Sustainment: Capacity

    Time frame: Annually for 6 years

    Capacity continues over time. Operationalized as the slope of capacity annually after the county moves into the "intervention" phase of the stepped wedge design

  8. Cost of implementation approaches

    Time frame: Continuous over 6 years

    Cost via our grant accounting

  9. Cost-effectiveness of implementation approaches

    Time frame: Continuous over 6 years

    The primary cost-effectiveness measure will be non-severe maternal morbidity, calculating intervention costs per point of score reduction. Secondary cost-effectiveness measures will be severe maternal morbidity and maternal mortality. Prevented severe maternal morbidity (SMM) will be also monetized using Medicaid claims data by calculating the difference between Medicaid delivery expenditures between women/birthing persons with SMM and without SMM using our own claims data and prior estimates. The value of a statistical life, currently around $10 million, will be used to monetize prevented maternal deaths.

  10. Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality

    Time frame: Continuous for 6 years

    These will be assessed during pregnancy and through one-year postpartum using state Medicaid claims records and death records. The investigators will assess overall rates and rates relative to non-Hispanic white people.

Study contacts

Contact information is provided by the study sponsor or research team.

Simran Dhaliwal Project Coordinator

CONTACT

[email protected]

810-600-5630

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

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

Registry information

Official study title

Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality (MIRACLE Center Project 3)

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Aug 7, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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