Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06682520

Conditions

Health Care Utilization

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Postpartum NEST-Rural Program (Hospital based service model)

Study Details

Brief summary:

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 counties in North Carolina. Overarching Hypothesis: Mothers and infants residing in rural communities, randomized to the NEST-Rural care model over the 3-year course of the project will: 1. Receive more coordinated care for addressing social, mental and physical health needs. 2. Experience fewer postpartum hospital readmissions and decreased utilization of emergency departments (ED) for healthcare. 3. Experience higher adherence to American College of Obstetricians and Gynecologists (ACOG) and American Academy of Pediatrics (AAP) guidelines for preventive care, including recently updated ongoing postpartum care, serial well-child visits and vaccinations compared to those assigned to usual care. This group will be compared to those assigned to usual care,

Conditions

Health Care Utilization

Study ID

NCT06682520

Start date

Dec 4, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Women that deliver an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and currently reside in Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
2. Women that delivered an infant(s) at home, were transported to Atrium Health Wake Forest Baptist and received postpartum care at The Birth Center and currently reside in Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
3. Ages 18 years or older

Exclusion Criteria:

1. Women that delivered an infant(s) and did not receive postpartum care at The Birth Center at Atrium Health Wake Forest Baptist.
2. Women that currently reside outside of Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
3. Under 18 years of age

Study Design

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Postpartum NEST-Rural Program Group

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

no intervention: Postpartum Usual Care Group

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

Interventions

Postpartum NEST-Rural Program (Hospital based service model)

NEST-Rural services will include 3-5 nurse encounters and, if indicated, up to 3 social work encounters with mothers and their infants in the postpartum period, postpartum remote blood pressure monitoring, breastfeeding support, infant weight checks, linking mothers and infants to needed social, behavioral, and health-related resources, and integration of service delivery with healthcare providers.

Primary outcome measure

  • Median number of hospital readmissions - Maternal [ Time Frame: Baseline through 30 days postpartum ]
  • Median number of hospital readmissions - Maternal [ Time Frame: Baseline through 90 days postpartum ]
  • Median number of encounters for urgent or emergent care - Maternal [ Time Frame: Baseline through 30 days postpartum ]
  • Median number of encounters for urgent or emergent care - Maternal [ Time Frame: Baseline through 90 days postpartum ]
  • Proportion of women that attend recommended postpartum visits [ Time Frame: Baseline through 90 days postpartum ]
  • Median number of hospital readmissions - Infant [ Time Frame: Baseline through 30 days postpartum ]
  • Median number of hospital readmissions - Infant [ Time Frame: Baseline through 90 days postpartum ]
  • Median number of encounters for urgent or emergent care - Infant [ Time Frame: Baseline through 30 days postpartum ]
  • Median number of encounters for urgent or emergent care - Infant [ Time Frame: Baseline through 90 days postpartum ]
  • Proportion of infants receiving a visit with an ambulatory care provider [ Time Frame: Baseline through 21 days postpartum ]
  • Proportion of infants that received >/= 4 well-child care visits with an ambulatory care provider [ Time Frame: Baseline through 274 days postpartum ]

Central Contacts and Locations

Central contacts

Elizabeth T. Jensen, MPH PhD

336-713-3132elizabeth.jensen@wfusm.edu

David M. Stamilio, MD, MSCE

336-716-0271david.stamilio@wfusm.edu

Locations

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Angie Almond, MEd

336-713-4524angie.almond@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Remote blood pressure monitoring
  • Postpartum Nurse home visiting
  • Postpartum Health Care Services
  • Postpartum Hospital Program Service Model
  • Maternal Health
  • Newborn Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-10-28.