Clinical trial NCT06541951: Scaling up Maternal Health Equity Best Practices
Official title: Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality (MIRACLE Center Project 3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Mortality Disparities
Maternal Morbidity Disparities
Keywords: health inequities
maternal health
maternal mortality
implementation science
healthcare disparities
African Americans
Hispanic
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster-randomized stepped wedge design
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM)
timeFrame: Continuous for 6 years
Secondary outcomes:
measure: Scale-up: Penetration
timeFrame: Assessed annually for 6 years
measure: Scale-up: Reach
timeFrame: Assessed annually for 6 years
measure: Scale-up: Control for delivery
timeFrame: Assessed annually for 6 years
measure: Scale-up: Effectiveness
timeFrame: Assessed annually for 6 years
measure: Sustainment: Fidelity
timeFrame: Annually for 6 years
measure: Sustainment: Health benefits
timeFrame: Annually for 6 years
measure: Sustainment: Capacity
timeFrame: Annually for 6 years
measure: Cost of implementation approaches
timeFrame: Continuous over 6 years
measure: Cost-effectiveness of implementation approaches
timeFrame: Continuous over 6 years
measure: Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality
timeFrame: Continuous for 6 years
Other outcomes:
Locations:
city: Flint
country: United States
facility: Michigan State University on behalf on 12 Michigan counties
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jennifer E. Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health
name: Jaye Clement, MPH, MPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health
name: Amy Loree, PhD
role: PRINCIPAL_INVESTIGATOR
References: