Postpartum Education and Support for Rural Health Care Utilization

(NEST-Rural Trial)

Overseen By Elizabeth T. Jensen, MPH PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Outside counties, Under 18, 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: 9

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called the Postpartum NEST-Rural Program, designed to assist postpartum women in rural areas of North Carolina. The goal is to determine if this program can improve care coordination and reduce hospital visits for new mothers and their babies. Participants will receive additional support, including home visits, a blood pressure monitor, and access to a health app. Women who have recently given birth at a specific birth center and reside in Davidson, Davie, Stokes, Wilkes, or Yadkin County may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative postpartum care solutions in rural communities.

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 the NEST-Rural Program is safe for postpartum women?

Research has shown that similar programs, such as the Postpartum NEST-Rural Program, are generally well-received by participants. These programs often include home visits, online check-ins, and access to health apps. Studies from similar programs have found that participants usually have positive experiences with few negative effects. This research suggests that such programs are safe for new mothers, providing supportive care without major safety concerns. Although the NEST-Rural Program itself is new, its components are based on proven and safe practices used in other healthcare settings.

Why are researchers excited about this trial?

Researchers are excited about the Postpartum NEST-Rural Program because it combines technology and personalized care to support new mothers in rural areas, a group that often lacks access to postpartum resources. Unlike traditional postpartum care, which typically offers basic follow-up and community resource information, this program includes innovative features like a blood pressure monitor and access to the Babyscripts smartphone app for ongoing health tracking and education. Additionally, the program offers home or telehealth nurse visits and personalized support from a Family Outreach Specialist, enhancing the level of care and potentially improving health outcomes for mothers who might otherwise face barriers to receiving comprehensive postpartum care.

What evidence suggests that the NEST-Rural Program is effective for postpartum care?

Research shows that the Postpartum NEST-Rural Program, which participants in this trial may receive, aims to improve care for new mothers in rural areas. Although specific data on this program is limited, similar programs have demonstrated benefits such as reduced hospital readmissions and emergency room visits. These programs often assist mothers in adhering to health guidelines for themselves and their babies. By utilizing tools like telehealth and home visits, the NEST-Rural Program is expected to facilitate access to necessary care for mothers. Overall, the program seeks to better address the health needs of mothers and infants in rural areas. ^{1 2 3 4 5}

Who Is on the Research Team?

Elizabeth T. Jensen, MPH PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who have recently given birth at The Birth Center at Atrium Health Wake Forest Baptist, or were transported there after a home delivery, and live in one of five specified rural counties in North Carolina.

Inclusion Criteria

I recently gave birth at The Birth Center and live in one of the specified NC counties.

I gave birth at home, received postpartum care at The Birth Center, and live in one of the specified NC counties.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postpartum NEST-Rural Program

Participants receive coordinated postpartum care including nurse encounters, remote blood pressure monitoring, and support services

6 weeks

3-5 nurse encounters (home or telehealth)

Follow-up

Participants are monitored for adherence to postpartum care guidelines and support needs

90 days

Follow-up phone call at 6 weeks

Long-term Follow-up

Participants are monitored for long-term health outcomes and adherence to care guidelines

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Postpartum NEST-Rural Program

Trial Overview The study tests the NEST-Rural Program, which aims to provide coordinated postpartum care. It will be evaluated against usual care to see if it improves adherence to health guidelines and reduces hospital readmissions and emergency department visits over three years.

How Is the Trial Designed?

Group I: Postpartum NEST-Rural Program Group Experimental Treatment 1 Intervention

Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following NEST-Rural Program: * Information about services and resources available in your community * A blood pressure monitor. * Access to the Babyscripts smartphone app. * A nurse visit(s) at home or via telehealth. * A visit(s) from a Family Outreach Specialist, if needed. * A follow-up phone call from a Coordinator in about 6 weeks

Group II: Postpartum Usual Care Group Active Control 1 Intervention

Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following: * Information about services and resources available in your community * A follow-up phone call from a Coordinator in about 6 weeks

Postpartum NEST-Rural Program is already approved in United States for the following indications:

Approved in United States as NEST-Rural Program for:

• Postpartum care
• Maternal health support
• Infant health support

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+

Published Research Related to This Trial

The Healthy & Home postpartum community nursing program effectively supports new mothers and their families through home visits and various resources, helping to bridge the gap between hospital discharge and community care.

This program, which includes services like breastfeeding support and mental health resources, has evolved over 25 years and demonstrates the importance of comprehensive follow-up care to prevent hospital readmissions and promote maternal and infant wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going home with baby: innovative and comprehensive support for new mothers. Olson, T., Bowen, A., Smith-Fehr, J., et al.[2023]

A review of 42 indicator sets related to maternal and infant health in remote Northern Territory communities identified over 1,000 individual indicators, with 656 deemed relevant for improving care for Aboriginal mothers and infants.

Despite the existence of many health indicators, few specifically address the unique challenges faced by remote maternal and infant health services, highlighting the need for tailored indicators to enhance data collection and inform policy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic indicators for remote Aboriginal maternal and infant health care: why it matters and where to start. Steenkamp, M., Bar-Zeev, S., Rumbold, A., et al.[2021]

A university-based perinatal care program effectively extended its services to underserved urban and rural populations through a multidisciplinary team approach, improving access to care.

The program has shown positive perinatal outcomes in four rural communities, serving as a model for perinatal access that has influenced state legislation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of comprehensive perinatal services through rural outreach: a model program. Bahry, VJ., Fullerton, JT., Lops, VR.[2019]

A collaborative effort at the University of New Mexico successfully developed a preceptor program to enhance the skills of nurses in rural areas for managing high-risk perinatal patients, overcoming initial barriers such as program approval and financial responsibilities.

Evaluations conducted six months after the program's implementation showed that participants had made significant changes in their nursing practices, indicating the program's effectiveness in improving care for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preceptorships in high-risk perinatal nursing for rural nurses: a pilot project. L'Esperance, C., DiGregorio, R., Wallerstedt, C.[2022]

The Rural Perinatal Traineeship Program (RPTP) effectively improved the knowledge and skills of perinatal RNs, with test scores increasing from 76% to 89% after the program, indicating a significant enhancement in their ability to care for high-risk pregnant women and sick newborns.

Feedback from participants led to the implementation of 77% of suggested changes in care practices and the acquisition of 90% of recommended equipment, demonstrating the program's impact on improving nursing practices in community hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing regional perinatal care: a clinical traineeship for perinatal nurses in a predominantly rural area. Clarke, SB.[2006]

A 2-year home-visiting program for socially disadvantaged mothers in rural South Australia, involving 225 participants, showed no significant improvement in maternal or child outcomes compared to a control group of 239 mothers before the program's implementation.

The lack of measurable effects may be attributed to challenges in program rollout, including recruitment and the broader responsibilities of rural nurses, suggesting that the program's effectiveness may differ in rural settings compared to urban areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of nurse home visiting for families in rural South Australia. Sawyer, MG., Pfeiffer, S., Sawyer, A., et al.[2022]

A study of 466,896 rural births found that 64.3% occurred in rural hospitals, while one-third took place in metropolitan hospitals, indicating a significant reliance on urban healthcare facilities by rural patients.

Rural patients who gave birth in metropolitan hospitals faced higher odds of adverse outcomes, with increased risks in both rural-serving (27% higher) and non-rural-serving (35% higher) hospitals, likely due to higher baseline illness severity among these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal outcomes for rural obstetric patients and neonates in rural-located and metropolitan-located hospitals. Handley, SC., Passarella, M., Interrante, JD., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06682520

Study Details | NCT06682520 | Evaluation of a Health ... This study was designed to evaluate the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural ...

2. withpower.com withpower.com/trial/postpartum-education-and-support-for-rural-health-care-utilization-87f7c

Postpartum Education and Support for Rural Health Care ... This study was designed to evaluate the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural ...

3. ctv.veeva.com ctv.veeva.com/study/evaluation-of-a-health-system-integrated-model-for-postpartum-education-and-support-in-rural-populat

Evaluation of a Health System Integrated Model for ... This study was designed to evaluate the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8403215/

A Systematic Review of Patient-, Provider-, and Health System ... Patient-level factors consistently associated with postpartum care included higher socioeconomic status, rural residence, fewer children, older age, medical ...

5. ciceroinstitute.org ciceroinstitute.org/research/rural-health-transformation-program-rfi-response-analysis/

Rural Health Transformation Program RFI Response ... Assisting rural communities to right-size their health care delivery systems by identifying needed preventative, ambulatory, pre-hospital, ...