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Evaluatie van een geïntegreerd gezondheidszorgsysteemmodel voor postpartumonderwijs en ondersteuning van plattelandsbevolking (NEST-Rural)

23 september 2026 bijgewerkt door: Wake Forest University Health Sciences

Evaluatie van een geïntegreerd gezondheidszorgsysteemmodel voor postpartumonderwijs en -ondersteuning in plattelandsbevolking - NEST-Rural

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,

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1300

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Ander: 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.
Geen tussenkomst: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Median number of hospital readmissions - Maternal
Tijdsspanne: Baseline through 30 days postpartum

Number of hospital readmissions in the 4th trimester
Baseline through 30 days postpartum
Median number of hospital readmissions - Maternal
Tijdsspanne: Baseline through 90 days postpartum

Number of hospital readmissions in the 4th trimester
Baseline through 90 days postpartum
Median number of encounters for urgent or emergent care - Maternal
Tijdsspanne: Baseline through 30 days postpartum

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
Tijdsspanne: Baseline through 90 days postpartum

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
Tijdsspanne: Baseline through 90 days postpartum

Percentage of women that attended recommended visits to their obstetrician after delivery.
Baseline through 90 days postpartum
Median number of hospital readmissions - Infant
Tijdsspanne: Baseline through 30 days postpartum

Number of hospital readmissions after birth following hospital discharge.
Baseline through 30 days postpartum
Median number of hospital readmissions - Infant
Tijdsspanne: Baseline through 90 days postpartum

Number of hospital readmissions after birth following hospital discharge.
Baseline through 90 days postpartum
Median number of encounters for urgent or emergent care - Infant
Tijdsspanne: Baseline through 30 days postpartum

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
Tijdsspanne: Baseline through 90 days postpartum

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
Tijdsspanne: Baseline through 21 days postpartum

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
Tijdsspanne: Baseline through 274 days postpartum

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Median number of days with >/= 1 remote blood pressure obtained - Maternal
Tijdsspanne: Baseline through 21 days postpartum

Number of days that patients checked and remotely reported their blood pressure readings following hospital discharge.
Baseline through 21 days postpartum
Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained
Tijdsspanne: Baseline through 10 days postpartum

Percentage of women diagnosed with hypertensive disorders that checked and remotely reported at least one blood pressure reading.
Baseline through 10 days postpartum
Proportion of women with preeclampsia with severe features with at least one blood pressure obtained
Tijdsspanne: Baseline through 3 days postpartum

Percentage of women with preeclampsia with severe features checked and remotely reported at least one blood pressure reading.
Baseline through 3 days postpartum
Proportion of women exceeding 3 days length of stay in hospital after delivery
Tijdsspanne: Baseline through date of hospital discharge

Percentage of women that remain hospitalized for more than 3 days following delivery.
Baseline through date of hospital discharge
Median length of stay for hospital readmissions after delivery
Tijdsspanne: Baseline through 90 days postpartum

Number of days mothers are readmitted and remain hospitalized after delivery.
Baseline through 90 days postpartum
Proportion of women that attend a follow-up encounter with their primary care physician
Tijdsspanne: Baseline through 365 days postpartum

Percentage of women that have a follow-up visit with their primary care physician within the first year after giving birth.
Baseline through 365 days postpartum
Proportion of women who receive a nurse home visit
Tijdsspanne: Baseline through 30 days postpartum

Percentage of women who receive a nurse home visit within 30 days of discharge
Baseline through 30 days postpartum
Proportion of women eligible for an in-person home visit that received the in-person nurse visit
Tijdsspanne: Baseline through 30 days postpartum

Percentage of women eligible for an in-person nurse home visit that received the in-person home visit.
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
Tijdsspanne: Baseline through 45 days postpartum

Percentage of women eligible for an in-person social work home visit that received the in-person social work visit
Baseline through 45 days postpartum
Median number of hospital readmissions - Maternal
Tijdsspanne: Baseline through 365 days postpartum

Number of hospital readmissions within the first 2 years following delivery
Baseline through 365 days postpartum
Median number of hospital readmissions - Maternal
Tijdsspanne: Baseline through 730 days postpartum

Number of hospital readmissions within the first 2 years following delivery
Baseline through 730 days postpartum
Proportion of women scheduled for a mood check provider visit who received a mood check provider visit
Tijdsspanne: Baseline through 21 days postpartum

Number of women scheduled for a mood check visit and attended their mood check visit within 21 days of discharge after delivery
Baseline through 21 days postpartum
Proportion of infants that received recommended immunizations
Tijdsspanne: Baseline through Day 274

Percentage of infants that received 3 hepatitis B, 2-3 rotavirus (depending on which one is given), 3 diphtheria/tetanus/pertussis, 3 haemophilus influenzae type B, 3 pneumococcal conjugate vaccines, 3 inactivated polio, and 1 flu vaccine within the first 9 months after discharge
Baseline through Day 274
Proportion of infants exclusively receiving breastmilk at nurse encounter
Tijdsspanne: Baseline through Day 21

Percentage of infants exclusively breastfeeding at the time of the nurse home visit within the first 3 weeks after discharge.
Baseline through Day 21
Proportion of infants receiving any amount of breastmilk at nurse encounter
Tijdsspanne: Baseline through Day 21

Percentage of infants receiving any breastmilk at the time of the nurse home visit within the first 3 weeks after discharge
Baseline through Day 21
Median number of hospital readmissions - Infant
Tijdsspanne: Baseline through day 365

Number of hospital readmissions within the first 2 years following discharge.
Baseline through day 365
Median number of hospital readmissions - Infant
Tijdsspanne: Baseline through day 730

Number of hospital readmissions within the first 2 years following discharge.
Baseline through day 730

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Medewerkers

The Duke Endowment

Onderzoekers

  • Hoofdonderzoeker: Elizabeth T. Jensen, MPH PhD, Wake Forest University Health Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 december 2024

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2029

Studieregistratiedata

Eerst ingediend

6 november 2024

Eerst ingediend dat voldeed aan de QC-criteria

8 november 2024

Eerst geplaatst (Werkelijk)

12 november 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00113575

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Nee

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