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

Trial Summary

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 data supports the idea that Patient Navigation for High-Risk Pregnancy is an effective treatment?

The available research shows that Patient Navigation for High-Risk Pregnancy is effective in improving postpartum care, especially for low-income individuals. It helps bridge the gap between obstetric and primary care, ensuring better care coordination and patient engagement. This treatment is particularly beneficial in addressing social and structural barriers to healthcare, leading to improved health outcomes. While the evidence is still emerging, it suggests that patient navigation can enhance health and patient-reported outcomes during and after the postpartum period. ^{1 2 3 4 5}

What safety data exists for patient navigation in high-risk pregnancy?

The provided research does not directly address safety data for patient navigation in high-risk pregnancy. However, it highlights the potential benefits of patient navigation in improving postpartum care, especially for low-income individuals. The studies suggest that patient navigation is a promising method to enhance health outcomes by addressing barriers to care, but specific safety data is not detailed in the abstracts. ^{1 2 3 4 6}

Is the treatment 'Community-based prenatal/perinatal/postpartum patient navigator, Standard of Care' a promising treatment for high-risk pregnancy?

Yes, the treatment is promising because patient navigation helps improve care coordination and patient engagement, especially for those with low income. It addresses barriers to healthcare, ensuring timely access to necessary services, which is crucial during the postpartum period. ^{1 2 3 4 5}

What is the purpose of this trial?

This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.

Research Team

Anne L Dunlop, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

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

Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. [2023]

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

Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. [2023]

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

Implementation of postpartum navigation for low-income individuals at an urban academic medical center. [2023]

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

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]

5. United States 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. [2023]

6. England 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. [2022]