Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541951
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Scaling up Maternal Health Equity Best Practices
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality MIRACLE Center Project 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie care provided outside the hospital in outpatient and other community settings and coordination among care settings Given that 83 of US 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 151920 births including 49110 births to African American andor 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 morbiditymortality 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None