Prenatal Navigation Program for Maternal and Infant Health

Not currently recruiting at 1 trial location

Overseen By Helen Milojevich, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Outside Durham County, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new program designed to support mothers and infants by connecting them with essential health and community resources. The program, called "Navigation," includes visits with a guide who identifies family needs and makes referrals to health care and other services. The trial compares different approaches to determine which is most effective. Mothers visiting certain OB/GYN offices for their first prenatal appointment or specific pediatric care practices for their child's well visit may be eligible, especially if they speak English or Spanish. As an unphased trial, this study offers participants the chance to contribute to innovative community support solutions for families.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for maternal and infant health?

Research has shown that patient navigation programs, like the one in this study, are generally safe and easy to manage. These programs typically involve community helpers who assist families in accessing healthcare services. Studies have found that such programs can improve access to care and health outcomes, especially for low-income families.

In some cases, these programs have been linked to benefits such as reduced substance use and improved overall health for mothers and babies. No major reports of negative effects from the navigation approach itself have emerged. This suggests that the program is safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Navigation Intervention Prenatal 2.0 because it offers a comprehensive support system for expectant mothers beyond standard prenatal care. Unlike typical prenatal programs that focus mainly on health information, this intervention involves personal guidance from Navigators who help mothers navigate healthcare plans, manage household safety, and establish community connections. The program also tailors support to address specific family needs, including emotional support and managing parenting challenges, which could significantly enhance maternal and infant health outcomes. By focusing on a wide range of factors affecting family well-being, this approach seeks to address not only medical needs but also the social and emotional aspects of pregnancy and early parenting.

What evidence suggests that the Navigation Intervention could be effective for maternal and infant health?

Studies have shown that navigation programs play a crucial role in improving the health of mothers and babies. Research indicates that these programs help families access necessary healthcare and community resources, leading to better health outcomes. For example, patient navigation has been linked to fewer missed prenatal appointments, reducing the risk of premature births. In this trial, the Navigation Intervention Prenatal 2.0 program provides extra support by focusing on 13 key areas, including the health of caregivers and the well-being of infants. Early findings suggest that addressing these areas can greatly benefit both mothers and babies, resulting in healthier pregnancies and early childhood development. ^{2 4 6 7 8}

Who Is on the Research Team?

Kenneth Dodge, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for families in Durham County who visit certain OB/GYN offices for their first prenatal visit or the Roxboro Road Pediatric Care Practice for their child's well visits at 12, 24, or 36 months. Participants must speak English or Spanish. Families planning to move soon or with a parent having cognitive impairments that affect consent are excluded.

Inclusion Criteria

Primary language is English or Spanish

Families will be eligible for the study if they go to the certain OB/GYN offices (to be updated later) for their first prenatal visit

Families will be eligible for the study if they go to the Roxboro Road Pediatric Care Practice for their child's 12-, 24-, or 36-month well visit

Exclusion Criteria

families that are planning to move out of either county within the next 2 months at the time of recruitment

Families will also be ineligible if the parent has a cognitive impairment that impairs their ability to consent/participate.

Families residing outside of Durham County

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Prenatally (up until delivery of target child)

Navigation Intervention

Mothers are offered visits from a Navigator prenatally and postnatally at 12, 24, and 36 months to assess family needs and establish connections with community providers.

36 months

4 visits (in-person) at prenatal, 12, 24, and 36 months

Follow-up

Participants are monitored for the impact of the Navigation program on child health, development, and family service receipt.

63 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Intervention
• Navigation Intervention
• Navigation Intervention Prenatal 1.0
• Navigation Intervention Prenatal 2.0

Trial Overview The 'Navigation' program is being tested to see its effects on maternal and infant health. It involves several visits by mothers during prenatal stages and when the child is aged 12, 24, and 36 months to connect them with healthcare services and follow up after one month.

How Is the Trial Designed?

Group I: Navigation Intervention Prenatal 2.0 Experimental Treatment 1 Intervention

This program recruits mothers in OB/GYN offices. Mothers are offered visits from a Navigator prenatally and postnatally (12-, 24-, and 36-months). During visits, the Navigator works with the mother to identify family needs, establishes connections between the family and community providers, and follows up one month later to confirm these referrals. Navigators assess and support family needs across 13 factors: caregiver health, infant health, healthcare plans, childcare plans, parent-child relationship, management of infant crying/behavior, household safety/material supports, family/community violence, history of parenting difficulties, parent well-being, substance use, parent emotional support, and other needs not related to first 12 factors. Navigation 2.0 is a revision of 1.0 in which adjustments to the protocol were made to improve guidance for Community Navigators and aid their assessments of family needs.

Group II: Navigation Intervention Prenatal 1.0 (arm closed and modified to 2.0 design. Data will not be used) Experimental Treatment 1 Intervention

This program recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits (using prenatal navigation version 1.0), establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being.

Group III: Control Intervention Experimental Treatment 1 Intervention

Brief educational information will be provided about pregnancy (provided prenatally) and child development at 12, 24, and 36 months.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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]

In a postpartum patient navigation program, women who engaged in more frequent text message communication with navigators were significantly more likely to complete follow-up care, with an adjusted odds ratio of 2.89 for those exchanging six or more messages.

The study identified that messages focusing on rapport-building and maternal health, as well as the use of emoticons, positively influenced the likelihood of follow-up, highlighting the importance of supportive communication in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the use of text message communication in a postpartum patient navigation program for publicly insured women. Strohbach, A., Hu, F., Martinez, NG., et al.[2020]

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]

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]

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]

A systematic evaluation of prenatal health guidance documents from multiple countries revealed that evidence-based practices and collaboration among stakeholders are essential for effective prenatal health programs.

The proposed best practices model emphasizes the need for woman-centered care and community involvement to address various health determinants, aiming to reduce disparities and improve maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for the Design, Implementation and Evaluation of Prenatal Health Programs. Chedid, RA., Phillips, KP.[2020]

The Prenatal Nutrition Program (PNP) effectively increased knowledge about nutrition during pregnancy among 52 well-educated pregnant women, but it did not significantly change their attitudes or dietary behaviors.

Participants rated the PNP very favorably, suggesting that self-instruction programs can be a cost-effective alternative to traditional individual nutrition counseling, despite limited impact on behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A self-instruction nutrition program for pregnant women. Daelhousen, BB., Guthrie, HA.[2019]

The Strong Start for Mothers and Newborns initiative, launched by the Centers for Medicare and Medicaid Services, aims to reduce preterm births and low-birth-weight infants among Medicaid beneficiaries through public awareness and enhanced prenatal care models.

Alternative prenatal care models, like home visitation and group prenatal care, are being tested and may offer more effective care compared to traditional medical models, particularly for high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong Start for Mothers and Newborns: implications for prenatal care delivery. Krans, EE., Davis, MM.[2019]

The intervention targeted low-income Hispanic women in Arizona's migrant communities, utilizing a Spanish language prenatal curriculum and trained local health promoters (Promotoras) to enhance prenatal education.

The program aimed to improve maternal health outcomes by creating a support network with local health professionals, highlighting the importance of culturally relevant education and community involvement in healthcare initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using lay health workers: case study of a community-based prenatal intervention. Meister, JS., Warrick, LH., de Zapién, JG., et al.[2022]

Clients in the Wisconsin Health Department's Prenatal Care Coordination program reported high satisfaction with the services, primarily valuing the supportive nurse-client relationship and the information provided.

Most clients entered the program without specific expectations, indicating that the program's effectiveness may rely more on the quality of support and resources rather than pre-defined goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. Heitzman, M., Weitzel, J., Kroll, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04438031

Study Details | NCT04438031 | Navigation Study: Durham The purpose of the proposed study is to evaluate the implementation and impact of a new, community-wide prevention program, "Navigation", on maternal and ...

2. withpower.com withpower.com/trial/phase-10-2020-c3bc1

Prenatal Navigation Program for Maternal and Infant Health The Navigation program provides visits to assess family needs, connects them with healthcare, and provides health education, focusing on community ...

3. 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

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

Maternal Navigation: For the Common Good Maternal navigation for pregnant patients who chronically miss prenatal care appointments is necessary to reduce premature births and associated ...

5. trialstoday.org trialstoday.org/trial/NCT05588245

Trial of Community-based Patient Navigation This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04438031

Navigation Study: Durham The purpose of the proposed study is to evaluate the implementation and impact of a new, community-wide prevention program, "Navigation", on maternal and ...

7. reporter.nih.gov reporter.nih.gov/project-details/11112300

RePORT RePORTER - National Institutes of Health (NIH) | Emerging data support that the incorporation of community-based patient navigators can enhance the quality of care while addressing barriers that low-income ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037687162400245X

Patient navigation for perinatal substance use disorder ... Patient navigation was associated with reduced maternal substance use, increased receipt of services, and improved maternal and neonatal health.