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Recruiting NCT06682520

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

No phase Interventional Health Care Utilization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Postpartum NEST-Rural Program (Hospital based service model).
Who it may be relevant to
Registry conditions: Health Care Utilization. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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,

Detailed description

This is a Randomized Control Trial (RCT) designed study evaluating the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural counties (Davie, Davidson, Yadkin, Wilkes and Stokes counties) in North Carolina. The study cohort will be for all mothers residing in these rural counties and delivering their infant(s) in the Atrium Health Wake Forest Baptist Birth Center. It is anticipated that 1,300 mother-infant dyads will be enrolled and randomized to either usual care \[visit 4-6 weeks postpartum\] (\~650) or NEST-Rural care (\~650).

The NEST model is unique in that it supports both maternal and infant health, with an emphasis on using strategies aligned with evidence-based guidelines for postpartum and infant healthcare. Another important feature of NEST is integration of service delivery in the healthcare system. This integration facilitates reaching mother-infant dyads and bi-directional communication with the mother's and infant's healthcare providers to enable appropriate, timely healthcare. For example, as part of NEST, mothers are discharged from the hospital with a remote blood pressure monitor. Blood pressures are transmitted to a service hub through an app that is downloaded onto her phone prior to hospital discharge. The hub alerts the healthcare team, which follows-up with her to determine appropriate care.

Randomization to NEST-Rural services will include 3-5 nurse 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. Services will initiate in the postpartum hospital unit, with a NEST Coordinator introducing the program and identifying and making referrals and/or providing resources for emergent needs (e.g. pack-n-play, diapers), and offering and scheduling a follow-up nurse visit (home or telehealth-based, depending on needs) 2-3 weeks postpartum. Up to two additional nurse and/or social worker home/virtual visits will be provided, depending on the family's needs. At six weeks postpartum, the NEST Coordinator will contact the family to inquire whether any referrals were made and assess for continuing gaps in support. Following nurse encounters, a note will be sent to the mother's and infant's healthcare providers. If acute concerns are identified, the nurse will contact the provider immediately for additional care.

Interventions

  • Other 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 measures

  • 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]
Secondary outcome measures (12)
  • Median number of days with >/= 1 remote blood pressure obtained - Maternal [Time frame: Baseline through 21 days postpartum]
  • Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained [Time frame: Baseline through 10 days postpartum]
  • Proportion of women with preeclampsia with severe features with at least one blood pressure obtained [Time frame: Baseline through 3 days postpartum]
  • Proportion of women exceeding 3 days length of stay in hospital after delivery [Time frame: Baseline through date of hospital discharge]
  • Median length of stay for hospital readmissions after delivery [Time frame: Baseline through 90 days postpartum]
  • Proportion of women that attend a follow-up encounter with their primary care physician [Time frame: Baseline through 365 days postpartum]
  • Proportion of women who receive a nurse home visit [Time frame: Baseline through 30 days postpartum]
  • Proportion of women eligible for an in-person home visit that received the in-person nurse visit [Time frame: Baseline through 30 days postpartum]
  • Proportion of women eligible for an in-person social work home visit that received the in-person social work visit [Time frame: Baseline through 45 days postpartum]
  • Median number of hospital readmissions - Maternal [Time frame: Baseline through 365 days postpartum]
  • Median number of hospital readmissions - Maternal [Time frame: Baseline through 730 days postpartum]
  • Proportion of women scheduled for a mood check provider visit who received a mood check provider visit [Time frame: Baseline through 21 days postpartum]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Atrium Health Wake Forest Baptist — Winston-Salem

Identifiers

NCT: NCT06682520 · IRB00113575

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗