Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations

NCT06682520 | Recruiting

• 1 other identifier: IRB00113575
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Median number of hospital readmissions - Maternal

  Number of hospital readmissions in the 4th trimester

  Baseline through 30 days postpartum

• Median number of hospital readmissions - Maternal

  Number of hospital readmissions in the 4th trimester

  Baseline through 90 days postpartum

• Median number of encounters for urgent or emergent care - Maternal

  Number of visits to Urgent Care or the Emergency Room in the 4th trimester

  Baseline through 30 days postpartum

• Median number of encounters for urgent or emergent care - Maternal

  To determine number of visits to Urgent Care or the Emergency Room in the 4th trimester

  Baseline through 90 days postpartum

• Proportion of women that attend recommended postpartum visits

  Percentage of women that attended recommended visits to their obstetrician after delivery.

  Baseline through 90 days postpartum

• Median number of hospital readmissions - Infant

  Number of hospital readmissions after birth following hospital discharge.

  Baseline through 30 days postpartum

• Median number of hospital readmissions - Infant

  Number of hospital readmissions after birth following hospital discharge.

  Baseline through 90 days postpartum

• Median number of encounters for urgent or emergent care - Infant

  Number of visits to Urgent Care or the Emergency Room following hospital discharge.

  Baseline through 30 days postpartum

• Median number of encounters for urgent or emergent care - Infant

  Number of visits to Urgent Care or the Emergency Room following hospital discharge.

  Baseline through 90 days postpartum

• Proportion of infants receiving a visit with an ambulatory care provider

  Percentage of infants that attended recommended visits to their pediatric care provider within 21 days following hospital discharge

  Baseline through 21 days postpartum

• Proportion of infants that received >/= 4 well-child care visits with an ambulatory care provider

  Percentage of infants that attended recommended visits to their pediatric care provider within the first 9 months following hospital discharge

  Baseline through 274 days postpartum

Secondary Outcomes (17)

• Median number of days with >/= 1 remote blood pressure obtained - Maternal

  Baseline through 21 days postpartum

• Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained

  Baseline through 10 days postpartum

• Proportion of women with preeclampsia with severe features with at least one blood pressure obtained

  Baseline through 3 days postpartum

• Proportion of women exceeding 3 days length of stay in hospital after delivery

  Baseline through date of hospital discharge

• Median length of stay for hospital readmissions after delivery

  Baseline through 90 days postpartum

Study Arms (2)

Postpartum NEST-Rural Program Group

EXPERIMENTAL

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

Other: Postpartum NEST-Rural Program (Hospital based service model)

Postpartum Usual Care Group

NO 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

Interventions

Postpartum NEST-Rural Program (Hospital based service model) OTHER

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.

Postpartum NEST-Rural Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Ages 18 years or older

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Duke Endowment: collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Elizabeth T. Jensen, MPH PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth T. Jensen, MPH PhD

CONTACT

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

David M. Stamilio, MD, MSCE

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to one of two study arms: Postpartum Standard of Care (Control arm). Postpartum NEST-Rural Program Service model (Experimental arm).

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)