Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
NCT Number: NCT06682520
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,
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Request Info18 year and older
Female
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline through 30 days postpartum
Number of hospital readmissions in the 4th trimester
Time frame: Baseline through 90 days postpartum
Number of hospital readmissions in the 4th trimester
Time frame: Baseline through 30 days postpartum
Number of visits to Urgent Care or the Emergency Room in the 4th trimester
Time frame: Baseline through 90 days postpartum
To determine number of visits to Urgent Care or the Emergency Room in the 4th trimester
Time frame: Baseline through 90 days postpartum
Percentage of women that attended recommended visits to their obstetrician after delivery.
Time frame: Baseline through 30 days postpartum
Number of hospital readmissions after birth following hospital discharge.
Time frame: Baseline through 90 days postpartum
Number of hospital readmissions after birth following hospital discharge.
Time frame: Baseline through 30 days postpartum
Number of visits to Urgent Care or the Emergency Room following hospital discharge.
Time frame: Baseline through 90 days postpartum
Number of visits to Urgent Care or the Emergency Room following hospital discharge.
Time frame: Baseline through 21 days postpartum
Percentage of infants that attended recommended visits to their pediatric care provider within 21 days following hospital discharge
Time frame: 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
Time frame: Baseline through 21 days postpartum
Number of days that patients checked and remotely reported their blood pressure readings following hospital discharge.
Time frame: Baseline through 10 days postpartum
Percentage of women diagnosed with hypertensive disorders that checked and remotely reported at least one blood pressure reading.
Time frame: Baseline through 3 days postpartum
Percentage of women with preeclampsia with severe features checked and remotely reported at least one blood pressure reading.
Time frame: Baseline through date of hospital discharge
Percentage of women that remain hospitalized for more than 3 days following delivery.
Time frame: Baseline through 90 days postpartum
Number of days mothers are readmitted and remain hospitalized after delivery.
Time frame: 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.
Time frame: Baseline through 30 days postpartum
Percentage of women who receive a nurse home visit within 30 days of discharge
Time frame: Baseline through 30 days postpartum
Percentage of women eligible for an in-person nurse home visit that received the in-person home visit.
Time frame: 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
Time frame: Baseline through 365 days postpartum
Number of hospital readmissions within the first 2 years following delivery
Time frame: Baseline through 730 days postpartum
Number of hospital readmissions within the first 2 years following delivery
Time frame: 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
Time frame: 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
Time frame: Baseline through Day 21
Percentage of infants exclusively breastfeeding at the time of the nurse home visit within the first 3 weeks after discharge.
Time frame: 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
Time frame: Baseline through day 365
Number of hospital readmissions within the first 2 years following discharge.
Time frame: Baseline through day 730
Number of hospital readmissions within the first 2 years following discharge.
Contact information is provided by the study sponsor or research team.
David M. Stamilio, MD, MSCE
CONTACT
Elizabeth T. Jensen, MPH PhD
CONTACT
Wake Forest University Health Sciences
Other
Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations - NEST-Rural
Acronym: NEST-Rural
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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