Patient Navigation for High-Risk Pregnancy

Overseen By Anne L Dunlop, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Transfer care, Incarceration, Minors, Prisoners, Cognitively impaired, others

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

Compensation: Varies

Number of Visits: 14

540 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a community-based patient navigator can improve health outcomes for women with high-risk pregnancies. It targets Black, English-speaking pregnant women covered by Medicaid, who face social challenges and receive prenatal care at Grady. Participants will receive either the usual care or additional support from a patient navigator, who provides health education and social support from mid-pregnancy to a year after childbirth. The goal is to determine if this added support can positively impact maternal health and help reduce disparities. As an unphased study, this trial allows participants to contribute to important research that could enhance health outcomes for future mothers facing similar challenges.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that this patient navigation intervention is safe for high-risk pregnancies?

Research shows that community-based patient navigation is generally well-received. Studies have found that these programs improve health by providing support and education to patients. No major reports of negative effects from this type of program exist. Instead, patient navigation often leads to better adherence to medical advice and higher patient satisfaction. Since this program focuses on offering guidance and support rather than medical treatment, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the patient navigation approach for high-risk pregnancies because it offers personalized support that goes beyond the standard medical care. Unlike typical prenatal services that mainly focus on clinical check-ups, this method involves community-based patient navigators who provide additional health assessments, education, and social support. The navigators ensure consistent, proactive contact with patients, which helps address social and educational needs that can significantly impact pregnancy outcomes. This holistic approach could lead to better health results for both mothers and babies by offering tailored guidance throughout the prenatal and postpartum periods.

What evidence suggests that the community-based patient navigator is effective for high-risk pregnancy?

This trial will compare the use of a community-based patient navigator with standard care for high-risk pregnancies. Studies have shown that a community-based patient navigator can improve new mothers' health. Research indicates that patient navigators help new mothers stay engaged in postpartum care and increase the likelihood of using birth control. One study found that patient navigators reduce early births by supporting women who often miss prenatal check-ups. The navigator provides health check-ups, education, and social support, which are crucial for high-risk pregnancies. Overall, patient navigation can be a valuable tool to improve care for women who may not have easy access to medical services. ^{1 2 4 5 6}

Who Is on the Research Team?

Anne L Dunlop, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for Black, English-speaking pregnant women or individuals over 18 years old with Medicaid coverage. They must be less than 20 weeks pregnant with a single baby and have at least one unmet social need. Participants should plan to receive care and deliver at Grady, staying available through the first year postpartum.

Inclusion Criteria

I am a Black, English-speaking pregnant person on Medicaid, with unmet social needs, planning to receive care and deliver at Grady.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants receive a community-based patient navigator with 3 prenatal contacts offering health assessment, education, and social support

20 weeks

3 visits (in-person or virtual)

Postpartum Intervention

Participants continue with the community-based patient navigator with 5 postpartum contacts offering health assessment, education, and social support

12 months

5 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months postpartum

Data collection at 6-8 weeks and 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Community-based prenatal/perinatal/postpartum patient navigator
• Standard of Care

Trial Overview The study tests if having a community-based patient navigator from mid-pregnancy to one year after birth helps medically underserved women. It compares standard care against this added support in two groups randomly chosen among 540 participants.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will receive a community-based patient navigator with 3 prenatal contacts and 5 postpartum contacts; during each contact, the community-based patient navigator will offer health assessment and education, along with group education and social support.

Group II: Comparison Group (Standard of Care) Active Control 1 Intervention

Participants will receive the standard of care.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A study involving 28 primary care clinicians revealed strong support for implementing a postpartum patient navigation program to improve care coordination for individuals transitioning from obstetric to primary care.

Clinicians identified key navigation services that could enhance postpartum care, such as personalized support, effective visit management, and education on common postpartum health issues, highlighting the importance of tailored navigator training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. Filicko, A., Huennekens, K., Davis, K., et al.[2023]

Patient navigation (PN) programs in perinatal mental health show promising evidence for improving service engagement and clinical outcomes, but the current research is limited, with only 19 articles covering 13 different programs identified in the review.

There is significant variability in the implementation and effectiveness of PN models, highlighting the need for further research to better understand the facilitators and barriers to their success in enhancing access to mental health services for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation models for mental health of parents expecting or caring for an infant or young child: A systematic review. Harris, SA., Harrison, M., Hazell-Raine, K., et al.[2023]

Obstetric providers believe that patient navigation programs could significantly enhance postpartum care for low-income patients, emphasizing the need for navigators to have strong interpersonal skills and advocacy qualities.

Recommendations for implementing these programs include comprehensive training for navigators on the healthcare system and effective health education, as well as identifying valuable services they can provide to improve care continuity and coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. Ruderman, RS., Dahl, EC., Williams, BR., et al.[2023]

The OB Nest prenatal care model, which includes fewer in-person visits supplemented by virtual connections and home monitoring, aims to maintain or improve patient satisfaction and care continuity for low-risk pregnant women.

This study will evaluate both the effectiveness and feasibility of the OB Nest model compared to standard care, using a mixed-methods approach to gather insights on patient satisfaction, health outcomes, and implementation experiences from both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. Ridgeway, JL., LeBlanc, A., Branda, M., et al.[2022]

The implementation of a postpartum patient navigation program at an urban academic medical center showed high patient needs, particularly in the first three months postpartum, indicating that such programs can effectively address critical gaps in postpartum care.

Despite initial challenges like clinician unfamiliarity and the complexity of the navigation process, the program's adaptability and the navigators' increased self-efficacy over time suggest that patient navigation can enhance care coordination and support for postpartum patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of postpartum navigation for low-income individuals at an urban academic medical center. Green, HM., Carmona-Barrera, V., Diaz, L., et al.[2023]

The postpartum period is crucial for improving maternal health, but many individuals face barriers to effective care, leading to poor health outcomes; patient navigation is a promising intervention to help overcome these obstacles.

A comprehensive training guide for postpartum patient navigators was developed, emphasizing six core elements essential for effective navigation, which can be adapted for various healthcare settings to enhance postpartum care access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Yee, LM., Williams, B., Green, HM., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05588245/trial-of-community-based-patient-navigation

Trial of Community-based Patient Navigation This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5400713/

Using a Patient Navigator to Improve Postpartum Care in ... Implementation of a postpartum navigation program was associated with improved retention in routine postpartum care and frequency of contraception uptake.

3. withpower.com withpower.com/trial/phase-pregnancy-related-1-2023-3764f

Patient Navigation for High-Risk Pregnancy This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk ...

4. ajmc.com ajmc.com/view/maternal-navigation-for-the-common-good

Maternal Navigation: For the Common Good Maternal navigation for pregnant patients who chronically miss prenatal care appointments is necessary to reduce premature births and associated ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11073553/

Patient navigation in women's health care for maternal ... This study investigated the scope of patient navigation studies on women's health care for maternal health and noncancerous gynecologic conditions

6. reporter.nih.gov reporter.nih.gov/project-details/11075592

Maternal Health Navigator intervention to reduce ... Community-based patient navigation is an emerging successful approach to improving community health. We propose a community-centric intervention, called ...