Maternal Mortality DisparitiesNCT06541951
Scaling up Maternal Health Equity Best Practices
A study testing Services as usual and Scale-up implementation approach in people with Maternal Mortality Disparities and Maternal Morbidity Disparities, run by Michigan State University at 1 site in United States.
Trial summary
This study works with prenatal and postnatal care providers in 12 Michigan counties to scale up best practices for maternal health equity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Mortality Disparities, Maternal Morbidity Disparities
- What is being tested?
- Services as usual and Scale-up implementation approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University on behalf on 12 Michigan counties
Flint, Michigan, 48503-4684
Jennifer Johnson, PhD, (810) 600-5669, jjohns@msu.edu
Amy Loree, PhD, 313-874-5452, aloree1@hfhs.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Services as usual, Scale-up implementation approach
- Keywords
- health inequities, maternal health, maternal mortality, implementation science, healthcare disparities, African Americans, Hispanic
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Services as usualOther
During this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures
Scale-up implementation approachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Services as usual | Active comparator | Services as usual before maternal health equity implementation efforts Receives: Other: Services as usual |
| Scale-up implementation approach | Experimental | An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners. Receives: Other: Scale-up implementation approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Continuous for 6 years
Secondary outcomes (10)
Scale-up: Penetration
Penetration (% providers/staff using recommended maternal health equity practices)
Measured: Assessed annually for 6 years
Scale-up: Reach
Number of perinatal people receiving recommended practices
Measured: 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
Measured: Assessed annually for 6 years
Scale-up: Effectiveness
Effectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses.
Measured: 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
Measured: 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
Measured: 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
Measured: Annually for 6 years
Cost of implementation approaches
Cost via our grant accounting
Measured: 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.
Measured: 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.
Measured: Continuous for 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Nov 2024
- Primary completionApr 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Mortality DisparitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cluster-randomized stepped wedge design
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jennifer E. Johnson, Michigan State University
- Investigators
- Jennifer E. Johnson, Ph.D., Principal investigator, Michigan State UniversityJaye Clement, MPH, MPP, Principal investigator, Henry Ford HealthAmy Loree, PhD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541951
- Sponsor's protocol ID
- STUDY00009307
- Other IDs
- U54HD113291
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Johnson JE, Clement J, Sikorskii A, Loree A, Meulen MV, Roman L, Dearing JW, Bolder H, White JM, Sokol R, Meghea C. A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol. Implement Sci Commun. 2025 Feb 20;6(1):19. doi: 10.1186/s43058-024-00677-7.
PubMed 39980059
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality (MIRACLE Center Project 3)
- ClinicalTrials.gov ID
- NCT06541951
- Acronym / sponsor ID
- STUDY00009307
- Keywords
- health inequities, maternal health, maternal mortality, implementation science, healthcare disparities, African Americans, Hispanic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Cluster-randomized stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Services as usual | Active comparator | Other: Services as usualServices as usual before maternal health equity implementation efforts |
| Scale-up implementation approach | Experimental | Other: Scale-up implementation approachAn implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Services as usualDuring this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures | Other | Services as usual |
| Scale-up implementation approachAn 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. | Other | Scale-up implementation approach |
Primary outcome
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.
10 secondary outcomes
Scale-up: Penetration
Time frame: Assessed annually for 6 years
Scale-up: Reach
Time frame: Assessed annually for 6 years
Scale-up: Control for delivery
Time frame: Assessed annually for 6 years
Scale-up: Effectiveness
Time frame: Assessed annually for 6 years
Sustainment: Fidelity
Time frame: Annually for 6 years
Sustainment: Health benefits
Time frame: Annually for 6 years
Sustainment: Capacity
Time frame: Annually for 6 years
Cost of implementation approaches
Time frame: Continuous over 6 years
Cost-effectiveness of implementation approaches
Time frame: 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
Time frame: Continuous for 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 39980059Johnson JE, Clement J, Sikorskii A, Loree A, Meulen MV, Roman L, Dearing JW, Bolder H, White JM, Sokol R, Meghea C. A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol. Implement Sci Commun. 2025 Feb 20;6(1):19. doi: 10.1186/s43058-024-00677-7.
- Individual participant dataSharing planned: No. 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.
Related trials for Maternal Mortality Disparities
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer E. Johnson, Ph.D. principal investigator
Michigan State University
Jaye Clement, MPH, MPP principal investigator
Henry Ford Health
Amy Loree, PhD principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Services as usual and Scale-up implementation approach in people with Maternal Mortality Disparities and Maternal Morbidity Disparities, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simran Dhaliwal Project Coordinator (810-600-5630, MHMiracle@Msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM) (time frame: Continuous for 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06541951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.