Integrated Maternity Care for Reducing Maternal Morbidity

(ENHANCED Trial)

Recruiting at 2 trial locations

Overseen By Elizabeth Norton, MPH, MBE

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Unable to consent, Prior ENHANCED, 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: Throughout pregnancy

2300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Maternity care home model (MCHM)?

The patient-centered medical home model, similar to the Maternity Care Home Model, has been shown to improve continuity of care and enhance access, which are important for better health outcomes. Additionally, midwifery-led units, which are part of integrated maternity care, are associated with better perinatal outcomes and higher satisfaction among users and professionals. ^{1 2 3 4 5}

How is the Maternity Care Home Model treatment different from other maternity care treatments?

The Maternity Care Home Model (MCHM) is unique because it integrates various aspects of maternity care into a single, coordinated approach, focusing on continuity of care and shared decision-making, which are not always emphasized in traditional maternity care models. This model aims to improve the quality and value of maternity care by making it a national policy priority and using performance measures to ensure high standards. ^{5 6 7 8 9}

What is the purpose of this trial?

The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM. Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum.

Research Team

Sindhu K Srinivas, MD, MSCE

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for BIPOC patients experiencing perinatal morbidity. It's designed to help those who are pregnant and will follow them through one year after giving birth. The study seeks participants willing to be randomly assigned to different types of prenatal care.

Inclusion Criteria

Plan to deliver at the 2 Penn hospital sites

I am between 16 and 55 years old.

I can read and understand either English or Spanish.

Exclusion Criteria

Unable to provide written consent by being unable to read or sign informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive office-based prenatal care integrated with comprehensive social services within the maternity care home model or standard of care with individually outsourced social services referrals

Throughout pregnancy

Follow-up

Participants are monitored for severe maternal morbidity and other outcomes from delivery to 1 year postpartum

1 year postpartum

Postpartum Care

Participants attend routine postpartum visits and are assessed for various outcomes including lactation continuation and postpartum depression

Up to 12 weeks postpartum

Treatment Details

Interventions

• Maternity care home model (MCHM)

Trial Overview The study tests a maternity care home model (MCHM) against standard care. MCHM offers office-based prenatal care integrated with social services, while standard involves typical office visits with separate social service referrals.

Participant Groups

Group I: Maternity care home model (MCHM) Experimental Treatment 1 Intervention

Office based prenatal care integrated with comprehensive social services within the maternity care home model.

Group II: Usual care arm Active Control 1 Intervention

Office based prenatal care with individually outsourced social service referrals.

Maternity care home model (MCHM) is already approved in United States for the following indications:

Approved in United States as Maternity Care Home Model for:

• Reducing severe maternal morbidity (SMM) among Black indigenous and people of color (BIPOC) patients

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

The single-room maternity care model generally leads to high maternal satisfaction, as indicated by multiple studies, suggesting it may enhance the patient experience during childbirth.

Healthcare provider satisfaction with the single-room model is mixed, highlighting the need for further evaluation of provider experiences and potential impacts on care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-room maternity care: Systematic review and narrative synthesis. Ali, E., Norris, JM., Hall, M., et al.[2023]

The study found that both Intensive and Light-Touch Quality Improvement (QI) interventions significantly improved person-centered maternity care (PCMC) scores, with Intensive facilities increasing from 85.02 to 97.13 and Light-Touch facilities from 63.42 to 87.47, indicating effective strategies for enhancing maternal care experiences.

The research also revealed a 'halo' effect, where improvements in specific areas of provider-patient interaction led to broader enhancements in overall patient experiences during childbirth, suggesting that targeted interventions can have widespread positive impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India. Montagu, D., Giessler, K., Nakphong, MK., et al.[2022]

The introduction of caseload midwifery in metropolitan Sydney aims to improve continuity of care for women during maternity, addressing the urgent need for change in Australia's maternity services.

This model promotes midwifery-led care at primary-level units, allowing for better integration with perinatal centers for advanced obstetric care when necessary, representing a significant shift towards more woman-centered maternity practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated service network in maternity--the implementation of a midwifery-led unit. Tracy, SK., Hartz, D., Nicholl, M., et al.[2019]

After implementing the patient-centered medical home (PCMH) model for two years, access to care improved by 7% and emergency department visits decreased by an impressive 75.3%.

The PCMH model also led to better population health outcomes, as indicated by improved healthcare effectiveness measures, and 75% of staff reported satisfaction with the new care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining selected patient outcomes and staff satisfaction in a primary care clinic at a military treatment facility after implementation of the patient-centered medical home. Savage, AI., Lauby, T., Burkard, JF.[2019]

Midwifery Units (MUs) are linked to better perinatal outcomes and higher satisfaction for both service users and professionals, yet they are not widely adopted in many countries.

A systematic review of 12 studies identified key factors for successfully implementing MUs, emphasizing the importance of addressing cultural, organizational, and professional readiness, as well as employing effective strategies at multiple levels to overcome barriers in maternity care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the strategies for implementing primary care models in maternity? A systematic review on midwifery units. Batinelli, L., Thaels, E., Leister, N., et al.[2022]

The Transforming Maternity Care (TMC) Project has successfully made maternity care quality a national policy priority, highlighting its importance in healthcare.

Significant advancements have been achieved in improving maternity care, including the development of performance measures and shared decision-making tools for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuing education module transforming maternity care: implementing the blueprint for action. Romano, AM.[2021]

Continuity of midwifery care is linked to improved maternal and neonatal outcomes, yet access to such care models remains limited in Australia despite recommendations from health authorities.

The study suggests that reforming Australia's hospital accreditation system could facilitate the implementation of continuity of midwifery care, although specific mechanisms for these changes are not yet clearly defined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital accreditation: Driving best outcomes through continuity of midwifery care? A scoping review. Gamble, J., Browne, J., Creedy, DK.[2021]

Effective maternity management programs are essential for improving maternal and infant health outcomes, particularly within Medicaid systems.

Organizations that integrate practical solutions from both public and private funding sources are more likely to create successful maternity management initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving optimal maternal and infant health outcomes for Medicaid patients, with application for commercial populations. Foust, RF., Carey, B.[2019]

A new evaluation model for maternity health programs in Iran was developed, consisting of five dimensions and 32 standards, aimed at improving the performance of primary health care centers.

The model achieved high scores in importance (91.55%) and applicability (87.22%), indicating its potential effectiveness in addressing challenges in maternity health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Evaluation Model for Maternity Care: A Mixed-Method Study from Iran. Firooznia, R., Dargahi, H., Jafari-Koshki, T., et al.[2022]

References

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

Single-room maternity care: Systematic review and narrative synthesis. [2023]

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

A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

An integrated service network in maternity--the implementation of a midwifery-led unit. [2019]

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

Examining selected patient outcomes and staff satisfaction in a primary care clinic at a military treatment facility after implementation of the patient-centered medical home. [2019]

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

What are the strategies for implementing primary care models in maternity? A systematic review on midwifery units. [2022]

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

Continuing education module transforming maternity care: implementing the blueprint for action. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Hospital accreditation: Driving best outcomes through continuity of midwifery care? A scoping review. [2021]

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

Achieving optimal maternal and infant health outcomes for Medicaid patients, with application for commercial populations. [2019]

9. Iran pubmed.ncbi.nlm.nih.gov

Developing an Evaluation Model for Maternity Care: A Mixed-Method Study from Iran. [2022]