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

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's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Patient Navigation Program treatment for pregnancy?

Patient navigation programs have been shown to improve health outcomes by reducing barriers and facilitating timely access to care, as seen in cancer treatment and survivorship. These programs can also enhance satisfaction with healthcare by providing support to underserved populations, suggesting potential benefits for pregnancy care. ^{1 2 3 4 5}

Is the Patient Navigation Program safe for use in humans?

The Patient Navigation Program has been used in various healthcare settings, including cancer care and perinatal care, to help patients navigate complex healthcare systems. While the research does not specifically address safety concerns, the program is generally considered a supportive intervention aimed at improving healthcare access and outcomes, suggesting it is safe for human use. ^{2 6 7 8 9}

How does the Patient Navigation Program treatment for pregnancy differ from other treatments?

The Patient Navigation Program is unique because it provides personalized support to help pregnant individuals navigate the healthcare system, addressing barriers to care and ensuring continuity, which is not a standard approach in traditional obstetric care. ^{1 2 4 7 10}

What is the purpose of this trial?

The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant persons' experiences, and health care utilization outcomes among low-income pregnant individuals and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant individuals who are randomized to receive antenatal patient navigation will be compared to pregnant individuals who are randomized to receive usual care. Navigators will support birthing people from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. The main objectives of the study are to: 1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of bundled social- and health systems-focused antenatal patient navigation for racially and ethnically diverse low-income individuals will reduce the incidence of a composite of adverse maternal outcomes all known to be associated with socioeconomic disadvantage and SDoH. We will also investigate maternal health care utilization. 2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal/pediatric health care utilization. 3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.

Research Team

Lynn M Yee, MD, MPH

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 assessment of social determinants of health. 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 social determinants of health, 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+

Findings from Research

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]

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]

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 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 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]

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]

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]

References

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

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

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. [2019]

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

5. England 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. [2022]

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

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. [2011]

7. Australia pubmed.ncbi.nlm.nih.gov

Experiences of cancer patients in a patient navigation program: a qualitative systematic review. [2019]

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

Impact of Patient Navigation Interventions on Timely Diagnostic Follow Up for Abnormal Cervical Screening. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Addressing racial disparities in perinatal care for African American/Black individuals in the Chicago community health setting: a qualitative study. [2023]

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

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]