Clinical trial NCT06682520: Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations
Official title: Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations - NEST-Rural
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Care Utilization
Keywords: Remote blood pressure monitoring
Postpartum Nurse home visiting
Postpartum Health Care Services
Postpartum Hospital Program Service Model
Maternal Health
Newborn Health
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
First posted: 2024-11-12
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to one of two study arms: Postpartum Standard of Care (Control arm). Postpartum NEST-Rural Program Service model (Experimental arm).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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,

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Median number of hospital readmissions - Maternal
timeFrame: Baseline through 30 days postpartum
measure: Median number of hospital readmissions - Maternal
timeFrame: Baseline through 90 days postpartum
measure: Median number of encounters for urgent or emergent care - Maternal
timeFrame: Baseline through 30 days postpartum
measure: Median number of encounters for urgent or emergent care - Maternal
timeFrame: Baseline through 90 days postpartum
measure: Proportion of women that attend recommended postpartum visits
timeFrame: Baseline through 90 days postpartum
measure: Median number of hospital readmissions - Infant
timeFrame: Baseline through 30 days postpartum
measure: Median number of hospital readmissions - Infant
timeFrame: Baseline through 90 days postpartum
measure: Median number of encounters for urgent or emergent care - Infant
timeFrame: Baseline through 30 days postpartum
measure: Median number of encounters for urgent or emergent care - Infant
timeFrame: Baseline through 90 days postpartum
measure: Proportion of infants receiving a visit with an ambulatory care provider
timeFrame: Baseline through 21 days postpartum
measure: Proportion of infants that received >/= 4 well-child care visits with an ambulatory care provider
timeFrame: Baseline through 274 days postpartum
Secondary outcomes:
measure: Median number of days with >/= 1 remote blood pressure obtained - Maternal
timeFrame: Baseline through 21 days postpartum
measure: Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained
timeFrame: Baseline through 10 days postpartum
measure: Proportion of women with preeclampsia with severe features with at least one blood pressure obtained
timeFrame: Baseline through 3 days postpartum
measure: Proportion of women exceeding 3 days length of stay in hospital after delivery
timeFrame: Baseline through date of hospital discharge
measure: Median length of stay for hospital readmissions after delivery
timeFrame: Baseline through 90 days postpartum
measure: Proportion of women that attend a follow-up encounter with their primary care physician
timeFrame: Baseline through 365 days postpartum
measure: Proportion of women who receive a nurse home visit
timeFrame: Baseline through 30 days postpartum
measure: Proportion of women eligible for an in-person home visit that received the in-person nurse visit
timeFrame: Baseline through 30 days postpartum
measure: Proportion of women eligible for an in-person social work home visit that received the in-person social work visit
timeFrame: Baseline through 45 days postpartum
measure: Median number of hospital readmissions - Maternal
timeFrame: Baseline through 365 days postpartum
measure: Median number of hospital readmissions - Maternal
timeFrame: Baseline through 730 days postpartum
measure: Proportion of women scheduled for a mood check provider visit who received a mood check provider visit
timeFrame: Baseline through 21 days postpartum
measure: Proportion of infants that received recommended immunizations
timeFrame: Baseline through Day 274
measure: Proportion of infants exclusively receiving breastmilk at nurse encounter
timeFrame: Baseline through Day 21
measure: Proportion of infants receiving any amount of breastmilk at nurse encounter
timeFrame: Baseline through Day 21
measure: Median number of hospital readmissions - Infant
timeFrame: Baseline through day 365
measure: Median number of hospital readmissions - Infant
timeFrame: Baseline through day 730
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Elizabeth T. Jensen, MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: