Scaling up Maternal Health Equity Best Practices
- Conditions
- Maternal Mortality DisparitiesMaternal Morbidity Disparities
- Interventions
- Other: Scale-up implementation approachOther: Services as usual
- Registration Number
- NCT06541951
- Lead Sponsor
- Michigan State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
-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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Scale-up implementation approach 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. Services as usual Services as usual Services as usual before maternal health equity implementation efforts
- Primary Outcome Measures
Name Time Method African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM) 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 Outcome Measures
Name Time Method Sustainment: Fidelity 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
Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality 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.
Scale-up: Control for delivery 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
Scale-up: Effectiveness Assessed annually for 6 years Effectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses.
Cost of implementation approaches Continuous over 6 years Cost via our grant accounting
Cost-effectiveness of implementation approaches 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.
Scale-up: Reach Assessed annually for 6 years Number of perinatal people receiving recommended practices
Sustainment: Health benefits 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
Sustainment: Capacity 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
Scale-up: Penetration Assessed annually for 6 years Penetration (% providers/staff using recommended maternal health equity practices)
Trial Locations
- Locations (1)
Michigan State University on behalf on 12 Michigan counties
🇺🇸Flint, Michigan, United States