Patient Navigation Program for New Mothers Postpartum Care

(NNM2 Trial)

Overseen By Lynn M Yee, MD, MPH

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: HIV, Prior NNM2, 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: 4

405 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 seems focused on providing support and navigation for postpartum care rather than altering medication regimens.

What data supports the effectiveness of the treatment Patient Navigation Program for New Mothers Postpartum Care?

Research suggests that patient navigation programs can improve postpartum care by helping new mothers overcome barriers to accessing healthcare, such as financial, cultural, and logistical challenges. These programs have been shown to enhance health outcomes and patient engagement, particularly for low-income individuals, by providing personalized support and coordination of care. ^{1 2 3 4 5}

How does the Patient Navigation Program differ from other treatments for postpartum care?

The Patient Navigation Program is unique because it uses trained personnel to help new mothers overcome financial, cultural, and logistical barriers to accessing healthcare, ensuring comprehensive and timely postpartum care. This approach is particularly beneficial for low-income individuals, as it focuses on personalized support and coordination of care, which is not typically offered by standard postpartum treatments. ^{1 2 3 5 6}

What is the purpose of this trial?

The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. Patient navigation is a barrier focused, long-term patient-centered intervention that offers support for a defined set of health services. The intervention under investigation is a comprehensive postpartum patient navigator program. Women who are randomized to receive patient navigation will be compared to women who are randomized to receive usual care. Navigators will support women through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum. The investigators will additionally conduct focus groups and surveys with clinical providers.

Research Team

Lynn Yee, MD, MPH

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for English or Spanish-speaking low-income women who are at least 16 years old, have had prenatal care at Northwestern Medicine Prentice Ambulatory Care, and are pregnant or postpartum. It's not for those planning to transfer care, with HIV, previously in NNM2, declined participation before, or in conflicting studies.

Inclusion Criteria

I can speak and read English or Spanish.

Low-income socioeconomic status (publicly funded prenatal care)

Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome

Exclusion Criteria

Prior enrollment in NNM2

I have declined to participate in a study during a previous pregnancy.

HIV (as these patients already receive intensive social support and navigation-like services at this institution)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Navigation

Participants receive intensive, individualized navigation services through 12 weeks postpartum, with ongoing, tapered navigation through one year postpartum.

12 weeks to 1 year

Regular interactions via tele-research and tele-navigation

Follow-up

Participants are monitored for health outcomes and patient-reported outcomes at 4-12 weeks and 11-13 months postpartum.

1 year

Surveys, interviews, and medical record reviews at 4-12 weeks and 11-13 months postpartum

Extension/Long-term Follow-up

Continued monitoring and support for participants based on individual needs, focusing on long-term health engagement.

Up to 5 years

Treatment Details

Interventions

• Patient Navigation Program

Trial Overview The study tests if a patient navigation program can improve health outcomes for new mothers over one year postpartum. Women will either receive this support program or usual care. The program focuses on overcoming social barriers and promoting self-care and engagement.

Participant Groups

Group I: Navigation Group Experimental Treatment 1 Intervention

Women who are randomized into NNM2 will be assigned to a patient navigator. The patient navigator will meet with the patient during pregnancy and after delivery occurs for introductions and education. The patient navigator will offer support and resources (transportation, community referrals, support for your mental health, connection to your doctors, etc.). The navigator will also help to schedule postpartum medical appointments, and will remind the patients of these appointments via text, email, or phone calls. The navigator will continue to provide psychosocial support, social needs support, and continued linkage to resources through one-year postpartum.

Group II: Non-navigation cohort Active Control 1 Intervention

No navigation will be provided; women will receive usual care.

Patient Navigation Program is already approved in United States for the following indications:

Approved in United States as Patient Navigation Program for:

• Support for breast cancer patients in underserved communities

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

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 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]

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 navigation program, Navigating New Motherhood, significantly improved attendance at postpartum visits, with 88.1% of participants returning for care compared to 70.3% in the historical cohort, indicating a strong impact on follow-up care.

Women in the navigation program also showed increased uptake of contraceptive methods, postpartum depression screening, and vaccinations, suggesting that the program not only enhanced visit attendance but also improved overall postpartum health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Patient Navigator to Improve Postpartum Care in an Urban Women's Health Clinic. Yee, LM., Martinez, NG., Nguyen, AT., et al.[2021]

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]

References

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

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

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

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

Using a Patient Navigator to Improve Postpartum Care in an Urban Women's Health Clinic. [2021]

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

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

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

Patient and Provider Perceptions of a Patient Navigation Program to Improve Postpartum Care Among Publicly Insured Women. [2022]