Scaling up Maternal Health Equity Best Practices

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

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

Study Overview

• Status: Recruiting
• Conditions: Maternal Mortality Disparities; Maternal Morbidity Disparities
• Intervention / Treatment: Other: Services as usual; Other: Scale-up implementation approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simran Dhaliwal Project Coordinator; Phone Number: 810-600-5630; Email: MHMiracle@Msu.edu

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48503-4684
      • Recruiting
      • Michigan State University on behalf on 12 Michigan counties
      • Contact: Jennifer Johnson, PhD; Phone Number: 810-600-5669; Email: jjohns@msu.edu
      • Contact: Amy Loree, PhD; Phone Number: 313-874-5452; Email: aloree1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Services as usual; Services as usual before maternal health equity implementation efforts	Other: Services as usual; During this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale-up: Penetration	Penetration (% providers/staff using recommended maternal health equity practices)	Assessed annually for 6 years
Scale-up: Reach	Number of perinatal people receiving recommended practices	Assessed annually for 6 years
Scale-up: Control for delivery	The degree to which control for delivery shifts to local actors and the practices are embedded in local delivery systems	Assessed annually for 6 years
Scale-up: Effectiveness	Effectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses.	Assessed annually for 6 years
Sustainment: Fidelity	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	Annually for 6 years
Sustainment: Health benefits	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	Annually for 6 years
Sustainment: Capacity	Capacity continues over time. Operationalized as the slope of capacity annually after the county moves into the "intervention" phase of the stepped wedge design	Annually for 6 years
Cost of implementation approaches	Cost via our grant accounting	Continuous over 6 years
Cost-effectiveness of implementation approaches	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.	Continuous over 6 years
Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality	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.	Continuous for 6 years

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: healthcare disparities; African Americans; Hispanic; implementation science; maternal health; maternal mortality; health inequities
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Parental Death; Maternal Death
• Other Study ID Numbers: STUDY00009307; U54HD113291 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The pre-existing statewide linked Medicaid dataset (individual level) is available from the Michigan Department of Health and Human Services, upon request, and with a new data use agreement to be initiated by the requesting individuals. Restrictions apply to the availability of these data, which were used under license for this study. De-identified implementation outcomes (provider level) data collected by the project will be available in appropriate national repositories and as well as by request from the PIs.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No