OPTIMIZE Program for Pregnancy Care

Overseen By Anastasia Harris, MPH, CHES

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Cognitive impairment, Incarceration, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 9 months

548 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the OPTIMIZE treatment for pregnancy care?

The research suggests that using an optimality index, which focuses on achieving the best possible outcomes with minimal intervention, can help improve perinatal care by monitoring and addressing complications effectively. ^{1 2 3 4 5}

Is the OPTIMIZE Program for Pregnancy Care safe for humans?

The research highlights efforts to improve safety in perinatal care, focusing on reducing adverse events and ensuring quality care, which suggests a general emphasis on safety in similar programs. ^{1 3 6 7 8}

How is the OPTIMIZE treatment for pregnancy care different from other treatments?

The OPTIMIZE treatment is unique because it focuses on a multifaceted approach to improve obstetric practices and outcomes, aiming for the best possible results with minimal intervention, tailored to the woman's social, medical, and obstetric history. This approach is different from standard care, which may not integrate these personalized and comprehensive strategies. ^{1 4 5 9 10}

Research Team

Melissa A Simon, MD

Principal Investigator

Northwestern University

Eligibility Criteria

The OPTIMIZE study is for English-speaking African American women aged 15 to 45 who are currently pregnant or have given birth within the last six months. It's not open to those who are incarcerated, unable to consent, or have cognitive impairments.

Inclusion Criteria

I am between 15 and 45 years old.

Pregnant or recently gave birth (less than 6 months post-delivery)

English speaking

Exclusion Criteria

You have difficulty thinking or remembering things clearly.

I am unable to give consent for myself.

Incarceration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of the OPTIMIZE perinatal care checklist with patient navigation support from initial prenatal visit through 12 weeks postpartum

Approximately 9 months

Follow-up

Participants are monitored for receipt of perinatal care components and secondary outcomes such as breastfeeding rates and postpartum depression

6 months postpartum

Treatment Details

Interventions

• OPTIMIZE

Trial Overview This trial is testing an intervention called OPTIMIZE, which involves clinic staff using a perinatal checklist and providing patient navigation support. Clinics will either use OPTIMIZE or continue with standard care, decided by random assignment.

Participant Groups

Group I: OPTIMIZE Experimental Treatment 1 Intervention

This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support.

Group II: Standard Care Active Control 1 Intervention

This arm includes provision of standard perinatal care.

OPTIMIZE is already approved in United States for the following indications:

Approved in United States as OPTIMIZE for:

• Improving perinatal care for African American pregnant women

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

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]

The study reviewed medical records of 147 Latina women to assess the effectiveness of an optimality index for monitoring perinatal complications, revealing optimality scores between 77.3% and 97.7%.

Women who experienced preterm births or had low-birthweight infants showed significantly lower optimality scores, indicating that the optimality index can help identify and understand health disparities in perinatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an Optimality Index to Understand Perinatal Health Disparities: A Pilot Study With Latina Immigrants. Gonzales, FA., Le, HN., Perry, DF.[2021]

The Optimality Index-US is a new measurement tool designed to evaluate perinatal outcomes by focusing on evidence-based optimal events rather than just rare adverse events, which can provide a more comprehensive view of maternal and child health.

This approach aims to help clinicians and researchers assess care practices that are both high quality and cost-effective, ultimately improving outcomes for all women giving birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the Optimality Index as a new approach to evaluating outcomes of maternity care. Murphy, PA., Fullerton, JT.[2019]

The concept of optimality in perinatal health care emphasizes achieving the best possible outcomes for mothers and babies while minimizing unnecessary interventions, tailored to individual medical and social histories.

Optimality is defined as a robust, efficient, and cost-effective approach, applicable across various scientific disciplines, highlighting its relevance in improving perinatal health care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A concept analysis of optimality in perinatal health. Kennedy, HP.[2019]

The evaluation of neonatal-perinatal care should prioritize clinical importance, quality of evidence, and the strength of recommendations to ensure effective patient care.

New treatments in neonatal-perinatal care should only be introduced if they demonstrate clear clinical benefits, minimal side effects, and cost-effectiveness, emphasizing the need for evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of care in neonatal-perinatal medicine: A joint position paper with the Society of Obstetricians and Gynaecologists of Canada. [2020]

A quality improvement initiative in 14 hospitals led to a significant increase in the adoption of standardized care processes in perinatal units, rising from 38% to 81% between 2008 and 2012, which is crucial for enhancing safety practices.

The study found a 14% reduction in adverse outcomes, indicating that implementing multiple integrated strategies, including teamwork training and standardized care, can effectively improve perinatal safety and reduce harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback. Riley, W., Begun, JW., Meredith, L., et al.[2019]

Analyzing existing perinatal data from 11 publicly available datasets allows researchers to study large and diverse populations, which can enhance the understanding of clinical processes and outcomes without risking harm to mothers and infants.

Using retrospective study designs can provide significant statistical power to investigate rare perinatal outcomes and support timely, ethical research that is directly relevant to improving clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing Datasets to Advance Perinatal Research. Phillippi, JC., Neal, JL., Carlson, NS., et al.[2023]

A regional database has been established in southern Sweden to improve the quality of obstetric and neonatal care by collecting data on approximately 20,000 deliveries annually, allowing for the identification of trends and quality indicators.

The project demonstrates that it is feasible to integrate various computer systems across different hospitals for effective data collection, highlighting the need for specialized databases to handle complex obstetric data that general systems cannot manage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A regional perinatal database in southern Sweden--a basis for quality assurance in obstetrics and neonatology. Molin, J.[2008]

A review of nine perinatal care management programs revealed mixed results, with some programs successfully reducing costs and improving outcomes, while others did not show significant benefits.

The variability in program designs and the use of ineffective study methods may contribute to the inconsistent findings, highlighting the need for more rigorous research to determine the effectiveness of perinatal care management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of perinatal care management programs: an integrated review. Carman, AF., Coverston, CR., Schwartz, R., et al.[2019]

A study of 6666 children born between 1977 and 1981 showed that complete perinatal care, which includes the 'Mutter-Kind-Pass' program plus clinical care, significantly reduces preterm deliveries, improves Apgar scores, and lowers perinatal mortality.

Minimal differences were observed between groups with no prenatal care and those with only the 'Mutter-Kind-Pass' program, indicating that optimal prenatal care requires additional clinical check-ups, especially between the 28th and 35th weeks of pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of prenatal care in general practice and in the clinic on the course of pregnancy and labor]. Sperno, R., Rudelstorfer, R., Gruber, W.[2006]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Using an Optimality Index to Understand Perinatal Health Disparities: A Pilot Study With Latina Immigrants. [2021]

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

Development of the Optimality Index as a new approach to evaluating outcomes of maternity care. [2019]

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

A concept analysis of optimality in perinatal health. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of care in neonatal-perinatal medicine: A joint position paper with the Society of Obstetricians and Gynaecologists of Canada. [2020]

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

Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback. [2019]

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

Utilizing Datasets to Advance Perinatal Research. [2023]

8. Denmark pubmed.ncbi.nlm.nih.gov

A regional perinatal database in southern Sweden--a basis for quality assurance in obstetrics and neonatology. [2008]

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

Evaluation of perinatal care management programs: an integrated review. [2019]

10. Austria pubmed.ncbi.nlm.nih.gov

[Effect of prenatal care in general practice and in the clinic on the course of pregnancy and labor]. [2006]