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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a patient navigation program can improve health outcomes for low-income new mothers. The program provides extra support from a navigator who assists with scheduling doctor appointments, providing transportation, and connecting to community resources. Participants are divided into two groups: one receiving navigator support and the other receiving usual care. Pregnant women or those who have recently given birth and receive publicly funded prenatal care might be suitable for this trial. As an unphased trial, this study offers a unique opportunity for additional support and potentially improved health outcomes for new mothers.

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 prior data suggests that this patient navigation program is safe for postpartum care?

Research has shown that patient navigation programs are safe and well-liked by both patients and healthcare providers. For example, studies have found that these programs assist new mothers by connecting them to resources and supporting their mental health. Importantly, patient navigation improves patient satisfaction and clinic operations without adding extra work for clinic staff. No major negative effects have been reported, indicating that this approach is generally safe for use in postpartum care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation Program for postpartum care because it offers personalized support that goes beyond traditional medical visits. Unlike standard care, which typically involves scheduled check-ups and general guidance, this program assigns new mothers a dedicated navigator. This navigator provides tailored assistance with scheduling appointments, mental health support, and connecting with community resources, all through convenient reminders via text, email, or phone calls. This hands-on, continuous support system aims to enhance the overall well-being of new mothers, potentially leading to better health outcomes during the crucial first year after childbirth.

What evidence suggests that the Patient Navigation Program is effective for postpartum care?

Research has shown that programs assisting new mothers in navigating healthcare can improve their health. In this trial, participants in the Navigation Group will receive support from a patient navigator. This navigator will assist with scheduling appointments, providing transportation, and connecting women with community resources. One study found that women who joined such a program felt more satisfied with their care than those without this support. These programs also reduce anxiety during pregnancy and after giving birth. Evidence suggests that these programs facilitate access to necessary care, leading to better overall health. ^{1 2 3 5 6}

Who Is on the Research Team?

Lynn Yee, MD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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 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]

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]

Citations

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

Using a Patient Navigator to Improve Postpartum Care in ... This is a prospective observational study of women enrolled in a patient navigation program compared to women receiving care prior to the program. Navigating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9472559/

Patient and Provider Perceptions of a Patient Navigation ... A postpartum patient navigation program can perceivably improve patient satisfaction, clinical care, and clinic workflow without burden to clinic providers.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/imhj.22075

Patient navigation models for mental health of parents ... Patient navigation (PN) aims to improve timely access to healthcare by helping patients to “navigate” complex service provision landscapes.

4. cancer.wisc.edu cancer.wisc.edu/research/wp-content/uploads/2019/05/Establishing-Patient-Navigation-7.2018.pdf

Establishing Effective Patient Navigation Programs in ... The overall purpose of the funding was to determine whether patient navigators help to reduce barriers to access to care and improve health care outcomes in ...

5. researchgate.net researchgate.net/publication/335670574_Patient_and_Provider_Perceptions_of_a_Patient_Navigation_Program_to_Improve_Postpartum_Care_Among_Publicly_Insured_Women

Patient and Provider Perceptions of a Patient Navigation ... Nurse navigation programs have been determined to decrease anxiety levels of women during pregnancy, delivery, and the postpartum period, as well as in women ...

6. ajog.org ajog.org/article/S0002-9378(21)00218-0/abstract

best practices for training of obstetrical patient navigators Navigating New Motherhood 2 is a randomized trial exploring whether patient navigation by a trained, lay postpartum navigator for individuals ...