Patient Navigation Program for Pregnancy

(PATH Trial)

Overseen By Brittney R Williams, MPH

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Transfer care, Prior PATH, Others

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

Compensation: Varies

Number of Visits: 7

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a patient navigation program to determine if it can improve the health of pregnant women and their babies. The program provides personalized support and resources, such as assistance with scheduling appointments or finding transportation, to low-income women and their newborns. Eligible participants should be pregnant with their first child, under 20 weeks along, and have low income. Participants will either work with a patient navigator or receive the usual pregnancy care. The goal is to determine if this extra support leads to better health outcomes for mothers and babies. As an unphased trial, this study offers a unique opportunity to access additional support that could enhance the pregnancy experience.

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 the Patient Navigation Program is safe for pregnant women?

Research has shown that patient navigation programs are safe and well-received. Studies on women's health and maternal care indicate that these programs can improve health outcomes without causing significant negative effects. For instance, a review of patient navigation in maternal health found no major safety concerns.

Patient navigation helps people access healthcare and resources more easily. This support includes assistance with scheduling appointments, arranging transportation, or connecting with community resources. These programs are generally considered a helpful way to improve health outcomes, especially for those who face challenges in accessing care.

Since this type of program is already used in other healthcare settings, it has a proven track record of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation Program for pregnancy because it offers a personalized approach to prenatal care that isn't typically part of standard care. Unlike traditional prenatal treatments that focus mainly on medical appointments and procedures, this program provides pregnant individuals with a dedicated patient navigator. This navigator offers comprehensive support, including education, resource connection, mental health support, and help with non-medical needs like transportation and communication with healthcare providers. This holistic support system aims to improve access to care and overall pregnancy outcomes, which could be a game-changer for those facing barriers to traditional healthcare access.

What evidence suggests that the Patient Navigation Program is effective for improving maternal and neonatal health?

Research shows that programs assisting patients in navigating the healthcare system can enhance health outcomes for pregnant women, particularly those facing barriers to care. Studies have found that these programs help women attend medical appointments and improve postpartum health. For instance, a program with multiple support features has been linked to better follow-up care after childbirth. Another study found that patient navigation reduces missed appointments, leading to improved overall health for mothers. In this trial, participants in the Navigation Group will receive the PATH patient navigation program, which could effectively assist low-income pregnant women by addressing healthcare access challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

Lynn M Yee, MD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

The PATH study is for low-income pregnant individuals before 20 weeks of gestation, focusing on those who may benefit from extra support due to socioeconomic disadvantages. It's not specified who can't join, but typically people with certain health conditions or risks might be excluded.

Inclusion Criteria

I am 16 years old or older.

Nulliparous: no prior pregnancies greater than or equal to 20 weeks excluding terminations

Low income: public insurance or residence in a neighborhood in which more than 10% of household incomes are less than 200% of the federal poverty line

Exclusion Criteria

Intent to transfer care to an outside institution

Prior enrollment in PATH

Concurrent enrollment in a study with competing aims/intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antenatal Navigation

Participants receive intensive, individualized patient navigation services throughout pregnancy, focusing on social determinants of health and healthcare access.

From enrollment (<20 weeks gestation) through delivery hospitalization

5 visits (in-person)

Postpartum Follow-up

Participants are monitored for maternal and neonatal health outcomes and healthcare utilization up to 9 months postpartum.

9 months postpartum

2 visits (in-person)

Long-term Follow-up

Participants' experiences and outcomes are evaluated through interviews and process mapping to prepare for widespread implementation of the PATH model.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation Program

Trial Overview This trial tests a patient navigation program designed to help pregnant individuals navigate healthcare services and address social determinants of health. Participants will either receive this specialized support or usual care, and the outcomes for mothers and babies will be compared.

How Is the Trial Designed?

Group I: Navigation Group Experimental Treatment 1 Intervention

Pregnant participants who are randomized to receive PATH patient navigation will be assigned to a patient navigator. The patient navigator will meet with the patient in early pregnancy for introductions, education, and assessing factors that influence health and access to care. The patient navigator will offer support and resources (e.g., appointment coordination and scheduling, communication with clinical team, transportation, community referrals, support for mental health, support for other non-medical needs, etc.). The navigator will provide support and continue linkage to resources through 2 weeks postpartum.

Group II: Non-navigation Group Active Control 1 Intervention

No navigation will be provided; pregnant participants will receive usual care.

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+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

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]

Patient navigation programs can significantly increase the rates of post-treatment surveillance mammography in women with breast cancer, suggesting a benefit in monitoring after treatment.

However, there is limited evidence that patient navigation improves treatment outcomes during breast cancer care, indicating a need for further research to fully understand its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. Baik, SH., Gallo, LC., Wells, KJ.[2019]

Patient navigation programs significantly enhance the experiences of adult cancer patients by providing emotional and logistical support, helping to reduce feelings of isolation during treatment.

Navigators play a crucial role in empowering patients through knowledge and practical assistance, ensuring continuity of care and alignment between patient needs and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of cancer patients in a patient navigation program: a qualitative systematic review. Tan, CH., Wilson, S., McConigley, R.[2019]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

The original patient navigation programs effectively combined community involvement and culturally sensitive care coordination to address disparities in cancer care, particularly for racial and ethnic minorities.

These programs functioned as a system rather than relying on individual navigators, with a structured team of navigators and directors working together to remove barriers and facilitate patient access to care, highlighting the importance of administrative support and community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Vargas, RB., Ryan, GW., Jackson, CA., et al.[2011]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., 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]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

Citations

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

Using a Patient Navigator to Improve Postpartum Care in ... Our data demonstrate that a multifaceted, patient-centered navigation program is significantly associated with improved postpartum retention in care as well as ...

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

Maternal Navigation: For the Common Good A system that navigates these barriers to a healthy pregnancy will help to decrease chronically missed appointments and thereby improve the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933325002289

Care utilization and clinical outcomes among high-risk ... We hypothesized that navigated patients would have higher attendance rates, as well as improved postpartum health outcomes.

4. ajogmfm.org ajogmfm.org/article/S2589-9333(24)00215-5/abstract

Utilizing perinatal patient navigation to address self ... Community-based care navigation is one approach to mitigating health disparities that has been successful with sustained impact in diverse health institutions ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03922334?term=navigtaing%20new%20motherhood&rank=1

Navigating New Motherhood 2 (NNM2) The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income ...

6. 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

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

best practices for training of obstetrical patient navigators Given the emerging evidence suggesting that patient navigation may be a promising method to improve health among postpartum individuals, our ...

8. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10901981211043117

Obstetric Provider Perspectives on Postpartum Patient ... Patient navigation programs have shown promise for improving health but are not widely used in obstetric care.