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Évaluation d'un modèle intégré de système de santé pour l'éducation et le soutien post-partum dans les populations rurales (NEST-Rural)

23 septembre 2026 mis à jour par: Wake Forest University Health Sciences

Évaluation d'un modèle intégré de système de santé pour l'éducation et le soutien post-partum dans les populations rurales - 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,

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1300

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • North Carolina
      • Winston-Salem, North Carolina, États-Unis, 27157

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Autre: 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.
Aucune 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Median number of hospital readmissions - Maternal
Délai: Baseline through 30 days postpartum

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Median number of days with >/= 1 remote blood pressure obtained - Maternal
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline through day 730

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Wake Forest University Health Sciences

Collaborateurs

The Duke Endowment

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 décembre 2024

Achèvement primaire (Estimé)

1 octobre 2027

Achèvement de l'étude (Estimé)

1 octobre 2029

Dates d'inscription aux études

Première soumission

6 novembre 2024

Première soumission répondant aux critères de contrôle qualité

8 novembre 2024

Première publication (Réel)

12 novembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB00113575

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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