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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new maternity care model, the maternity care home model (MCHM), can reduce severe health issues for pregnant BIPOC (Black, Indigenous, Asian, or Latina) patients. It compares two groups: one receives prenatal care with integrated social services, while the other receives standard care with separate social service referrals. The researchers seek to find out if the MCHM can help close the health gap caused by social and structural issues. Pregnant BIPOC patients planning to deliver at two specific hospitals and who can read English or Spanish are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative maternity care solutions.

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 prior data suggests that this maternity care home model is safe for reducing maternal morbidity?

Research has shown that the maternity care home model (MCHM) improves health outcomes for mothers and newborns by combining thorough prenatal care with social services. This approach addresses the physical, mental, and social needs of expecting mothers, particularly those from underserved communities.

Studies have not identified any specific safety concerns related to the MCHM itself. Since this model includes both standard prenatal care and additional social support services, the risks are not expected to exceed those of typical prenatal care. The focus remains on improving care rather than introducing new medical treatments, making it generally safe and well-tolerated for participants.

Major health organizations support this model, indicating confidence in its safety and effectiveness. However, as with any healthcare program, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Maternity Care Home Model (MCHM) because it offers a more integrated approach to prenatal care. Unlike the standard prenatal care, where social services are outsourced individually, MCHM combines office-based prenatal care with comprehensive social services all under one roof. This holistic method aims to reduce maternal morbidity by addressing a broader range of needs in a single setting, potentially leading to better health outcomes for mothers.

What evidence suggests that the maternity care home model is effective for reducing severe maternal morbidity?

This trial will compare the maternity care home model (MCHM) with usual care. Research has shown that the MCHM can reduce serious health issues for mothers by providing coordinated care. This model combines prenatal care with various social services, addressing gaps in both social and healthcare systems. Studies have found that patient-focused care can lower the risk of complications during and after pregnancy, especially for vulnerable groups. Evidence from similar programs, such as the Transforming Maternal Health (TMaH) initiative, supports these findings, demonstrating better health outcomes for mothers and reduced healthcare costs. Overall, the MCHM aims to enhance the quality of care and support for expectant mothers, leading to healthier results. ^{1 6 7 8 9}

Who Is on the Research Team?

Sindhu K Srinivas, MD, MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Participants must be willing and able to sign the informed consent form

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11017067

Enhance Trial-Enriched Holistic Care to Eradicate Maternal ... This randomized controlled intervention trial addresses social and organizational imbalances to reduce SMM and maternal mortality in the most at-risk patients.

2. reporter.nih.gov reporter.nih.gov/project-details/11158772

RP1 Praxis Project - NIH RePORTER Our long-term goal is to make patient-centered maternity care practices the standard across the care continuum—pre-conception to 1-year postpartum—to reduce ...

3. cms.gov cms.gov/priorities/innovation/innovation-models/transforming-maternal-health-tmah-model

Transforming Maternal Health (TMaH) Model TMaH is the newest CMS model designed to focus exclusively on improving maternal health care for women enrolled in Medicaid and Children's Health Insurance ...

4. dhcs.ca.gov dhcs.ca.gov/formsandpubs/publications/oc/Pages/2024/25-01-TMaH-1-6-25.aspx

25-01-TMaH-1-6-25 - DHCS By focusing on improving maternal outcomes, reducing costs, and enhancing the quality of care, the model aims to reduce low-risk cesareans, ...

5. medicaid.alabama.gov medicaid.alabama.gov/news_detail.aspx?ID=16502

Alabama Medicaid Receives Grant to Improve Maternal ... The TMaH Model is a comprehensive, evidence-based approach designed to drive improvements in maternal health. It seeks to make measurable ...

6. grants.nih.gov grants.nih.gov/grants/guide/rfa-files/RFA-NR-22-003.html

Expired RFA-NR-22-003 Advancing Integrated Models (AIM) of Care to Improve Maternal Health Outcomes among Women Who Experience Persistent Disparities (R21 Clinical Trial Optional)

7. mchb.hrsa.gov mchb.hrsa.gov/programs-impact/programs/integrated-maternal-model

Creating Health Care Models to Improve Maternal Health HRSA is funding new integrated health care models aimed at improving care during pregnancy and the postpartum period for underserved women.

8. cms.gov cms.gov/newsroom/press-releases/hhs-improve-maternal-health-outcomes-new-cms-care-model-expands-access-services-other-proven

HHS to Improve Maternal Health Outcomes with New ... “This model aims to improve health outcomes for mothers and their newborns, and support a system that makes mothers feel empowered, safe, and ...

9. achi.net achi.net/newsroom/cms-launches-maternal-care-model-aimed-at-improving-health-outcomes/

CMS Launches Maternal Care Model Aimed at Improving ... The whole-person approach will address physical, mental, and social needs experienced during pregnancy with a goal to improve outcomes and ...