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Evaluierung eines im Gesundheitssystem integrierten Modells für postpartale Bildung und Unterstützung in ländlichen Bevölkerungsgruppen (NEST-Rural)

23. September 2026 aktualisiert von: Wake Forest University Health Sciences

Evaluierung eines im Gesundheitssystem integrierten Modells für postpartale Bildung und Unterstützung in ländlichen Bevölkerungsgruppen – 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,

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

1300

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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
Sonstiges: 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.
Kein Eingriff: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Median number of hospital readmissions - Maternal
Zeitfenster: Baseline through 30 days postpartum

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Median number of days with >/= 1 remote blood pressure obtained - Maternal
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline through day 730

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Mitarbeiter

The Duke Endowment

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Dezember 2024

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

6. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. November 2024

Zuerst gepostet (Tatsächlich)

12. November 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00113575

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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