Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Ocena zintegrowanego modelu systemu opieki zdrowotnej w zakresie edukacji i wsparcia poporodowego w populacjach wiejskich (NEST-Rural)

23 września 2026 zaktualizowane przez: Wake Forest University Health Sciences

Ocena zintegrowanego modelu systemu opieki zdrowotnej w zakresie edukacji i wsparcia poporodowego w populacjach wiejskich - 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,

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1300

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Inny: 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.
Brak interwencji: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Median number of hospital readmissions - Maternal
Ramy czasowe: Baseline through 30 days postpartum

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Median number of days with >/= 1 remote blood pressure obtained - Maternal
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline through day 730

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wake Forest University Health Sciences

Współpracownicy

The Duke Endowment

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 grudnia 2024

Zakończenie podstawowe (Szacowany)

1 października 2027

Ukończenie studiów (Szacowany)

1 października 2029

Daty rejestracji na studia

Pierwszy przesłany

6 listopada 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 listopada 2024

Pierwszy wysłany (Rzeczywisty)

12 listopada 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00113575

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj