Improved Practices for Pregnancy Complications

Overseen By Simran Dhaliwal Project Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Scale-up implementation approach, Services as usual for pregnancy complications?

The research shows that scale-up implementation approaches have been effective in improving postpartum care in Niger and Mali, leading to better compliance with care standards and reduced postpartum hemorrhage. Additionally, a quality improvement initiative in a hospital setting successfully reduced major life-threatening complications by identifying and managing high-risk pregnancies more effectively. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles discuss adverse events (unintended harm from medical care) in hospitals, highlighting the importance of reporting and classifying these events to improve safety. While they don't provide specific safety data for the treatment in question, they emphasize the need for systematic approaches to identify and manage adverse events, which is crucial for ensuring patient safety in healthcare settings. ^{6 7 8 9 10}

How does the Scale-up implementation approach treatment for pregnancy complications differ from other treatments?

The Scale-up implementation approach is unique because it focuses on expanding successful health interventions to larger populations by systematically addressing barriers and engaging stakeholders, rather than just relying on traditional methods like policy and training. This approach ensures that effective practices are adapted to local contexts and sustained over time, which is different from standard treatments that may not consider these factors. ^{11 12 13 14 15}

What is the purpose of this trial?

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

Research Team

Jaye Clement, MPH, MPP

Principal Investigator

Henry Ford Health

Amy Loree, PhD

Principal Investigator

Henry Ford Health

Jennifer E. Johnson, Ph.D.

Principal Investigator

Michigan State University

Eligibility Criteria

This trial is for prenatal and postnatal care providers in 12 Michigan counties. It aims to improve maternal health equity, but specific eligibility criteria are not provided.

Inclusion Criteria

Provider must 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

All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Development and testing of a scale-up focused implementation approach for addressing PRAMM disparities in community care settings

6 years

Annual assessments

Follow-up

Participants are monitored for safety and effectiveness after implementation

12 months postpartum

Treatment Details

Interventions

• Scale-up implementation approach
• Services as usual

Trial Overview The study compares the effectiveness of a 'scale-up implementation approach' to enhance maternal health practices versus continuing with standard services as usual.

Participant Groups

Group I: Scale-up implementation approach Experimental Treatment 1 Intervention

An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners.

Group II: Services as usual Active Control 1 Intervention

Services as usual before maternal health equity implementation efforts

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A multifaceted intervention program in 95 French maternity units led to a significant reduction in suboptimal care for morbidity cases (7.6% vs. 11.5%) and a decrease in the overall incidence of perinatal morbidity (7.0 vs. 8.1‰).

However, the intervention did not significantly lower the combined rate of suboptimal care for morbidity and mortality cases, indicating that further improvements in mortality outcomes may require longer study durations and additional support structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. Dupont, C., Winer, N., Rabilloud, M., et al.[2018]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

In a review of 6579 medical records from New Zealand public hospitals in 1998, 12.9% of hospital admissions were associated with an adverse event, indicating a significant occurrence of safety issues in acute care settings.

Most adverse events had minor impacts on patients, with less than 15% leading to permanent disability or death, but they significantly increased hospital stays by an average of over nine days, highlighting the need for improved patient safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in New Zealand public hospitals I: occurrence and impact. Davis, P., Lay-Yee, R., Briant, R., et al.[2022]

Adverse drug events (ADE) are being considered as a primary metric for evaluating improvements in medication safety in New Zealand public hospitals, but there are challenges in determining the best measures to use.

A multi-stakeholder approach is necessary to develop a comprehensive framework for assessing medication safety, reflecting the need for collaboration among clinicians, policymakers, and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting the foundations right for the measurement of medication safety: the need for a meaningful conceptual frame. Ng, J., Scahill, S., Harrison, J.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving postpartum care for mothers and newborns in Niger and Mali: a case study of an integrated maternal and newborn improvement programme. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Scaling up improvements more quickly and effectively. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Preidentification of high-risk pregnancies to improve triaging at the time of admission and management of complications in labour room: a quality improvement initiative. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Did a quality improvement intervention improve quality of maternal health care? Implementation evaluation from a cluster-randomized controlled study. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. [2018]

6. Brazil pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse events in New Zealand public hospitals I: occurrence and impact. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Variations in the epidemiolgy of adverse events: methodology of the Harvard Medical Practice Design]. [2012]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Getting the foundations right for the measurement of medication safety: the need for a meaningful conceptual frame. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Systematic approaches to adverse events in obstetrics, Part I: Event identification and classification. [2018]

11. England pubmed.ncbi.nlm.nih.gov

A framework for scaling up health interventions: lessons from large-scale improvement initiatives in Africa. [2022]

12. Nigeria pubmed.ncbi.nlm.nih.gov

Government Ownership and Adaptation in Scale-Up: Experiences from Community-Based Family Planning Programme in the Democratic Republic of the Congo. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Navigating barriers: two-year follow up on recommendations to improve the use of maternal health guidelines in Kosovo. [2022]

14. England pubmed.ncbi.nlm.nih.gov

A protocol for evaluating a multi-level implementation theory to scale-up obstetric triage in referral hospitals in Ghana. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Barriers and enablers to guideline implementation strategies to improve obstetric care practice in low- and middle-income countries: a systematic review of qualitative evidence. [2019]