Prenatal Navigation Program for Maternal and Infant Health

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

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the proposed study is to evaluate the implementation and impact of a new, community-wide prevention program, "Navigation", on maternal and infant health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office and provides up to several visits (prenatally, 12 months, 24 months, and 36 months) to assess family needs, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals.

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 data supports the effectiveness of the Prenatal Navigation Program for Maternal and Infant Health treatment?

Patient navigation programs have shown promise in improving access to healthcare and clinical outcomes in various settings, including perinatal mental health and postpartum care. These programs help patients overcome barriers to healthcare, which can lead to better health outcomes for mothers and infants. ^{1 2 3 4 5}

How does the Prenatal Navigation Program differ from other treatments for maternal and infant health?

The Prenatal Navigation Program is unique because it focuses on providing comprehensive, accessible health education and resources to reduce prenatal health disparities, particularly for at-risk populations. Unlike traditional prenatal care, this program emphasizes community collaboration and tailored strategies to optimize maternal and infant health outcomes. ^{6 7 8 9 10}

Research Team

Kenneth Dodge, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Evaluating the use of text message communication in a postpartum patient navigation program for publicly insured women. [2020]

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

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]

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

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

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

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

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

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

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

A self-instruction nutrition program for pregnant women. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Strong Start for Mothers and Newborns: implications for prenatal care delivery. [2019]

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

Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Using lay health workers: case study of a community-based prenatal intervention. [2022]