ClinicalTrials.gg
RecruitingNCT06682520NEST-RuralUpdated Sep 28, 2026

Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations

An interventional study of Postpartum NEST-Rural Program (Hospital based service model) in Health Care Utilization, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Updated Sep 28, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 133 studies in Patient Acceptance of Health Care with a site in United States — 23 open to participants now, 35 under way, 1 of them phase 3. Patient Acceptance of Health Care · United States.

Planned enrollment
18th of 108
1,300 · median 262
Started
2024
with 12 others
No phase
99 of 133
20 open now
Primary completion
2027-10
later than 27 of 34 live
Registered
120th of 133
by date

Among the 133 studies in Patient Acceptance of Health Care with a site in United States, this one is the 18th largest by planned enrollment of the 108 interventional ones that give a count, is one of 13 that started in 2024, is one of 99 with no phase, reaches primary completion later than 27 of the 34 other live ones, and was the 120th registered.

Patient Acceptance of Health Care

308 studies on the registry are indexed under Patient Acceptance of Health Care; 53 are open to participants now.

Browse Patient Acceptance of Health Care studies →

Open to participants now

23 of the 133 studies in Patient Acceptance of Health Care with a site in United States are open now. Recruiting first, the newest first:

17 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 34 Patient Acceptance of Health Care studies recruiting now, 22 (65%) set no upper age limit and 9 (26%) stop at 75 or younger; 11 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

The full table on the hub →

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02

Study 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,

Read the 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,300 participants (estimated)

Study arms

  • 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

    Other: Postpartum NEST-Rural Program (Hospital based service model)

  • No 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

Interventions

  • OtherPostpartum 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.

06

What researchers measure

Primary outcomes

  1. Median number of hospital readmissions - Maternal

    Number of hospital readmissions in the 4th trimester

    Time frame: Baseline through 30 days postpartum

  2. Median number of hospital readmissions - Maternal

    Number of hospital readmissions in the 4th trimester

    Time frame: Baseline through 90 days postpartum

  3. Median number of encounters for urgent or emergent care - Maternal

    Number of visits to Urgent Care or the Emergency Room in the 4th trimester

    Time frame: Baseline through 30 days postpartum

  4. Median number of encounters for urgent or emergent care - Maternal

    To determine number of visits to Urgent Care or the Emergency Room in the 4th trimester

    Time frame: Baseline through 90 days postpartum

  5. Proportion of women that attend recommended postpartum visits

    Percentage of women that attended recommended visits to their obstetrician after delivery.

    Time frame: Baseline through 90 days postpartum

  6. Median number of hospital readmissions - Infant

    Number of hospital readmissions after birth following hospital discharge.

    Time frame: Baseline through 30 days postpartum

  7. Median number of hospital readmissions - Infant

    Number of hospital readmissions after birth following hospital discharge.

    Time frame: Baseline through 90 days postpartum

  8. Median number of encounters for urgent or emergent care - Infant

    Number of visits to Urgent Care or the Emergency Room following hospital discharge.

    Time frame: Baseline through 30 days postpartum

  9. Median number of encounters for urgent or emergent care - Infant

    Number of visits to Urgent Care or the Emergency Room following hospital discharge.

    Time frame: Baseline through 90 days postpartum

  10. Proportion of infants receiving a visit with an ambulatory care provider

    Percentage of infants that attended recommended visits to their pediatric care provider within 21 days following hospital discharge

    Time frame: Baseline through 21 days postpartum

  11. Proportion of infants that received >/= 4 well-child care visits with an ambulatory care provider

    Percentage of infants that attended recommended visits to their pediatric care provider within the first 9 months following hospital discharge

    Time frame: Baseline through 274 days postpartum

Secondary outcomes

  1. Median number of days with >/= 1 remote blood pressure obtained - Maternal

    Number of days that patients checked and remotely reported their blood pressure readings following hospital discharge.

    Time frame: Baseline through 21 days postpartum

  2. Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained

    Percentage of women diagnosed with hypertensive disorders that checked and remotely reported at least one blood pressure reading.

    Time frame: Baseline through 10 days postpartum

  3. Proportion of women with preeclampsia with severe features with at least one blood pressure obtained

    Percentage of women with preeclampsia with severe features checked and remotely reported at least one blood pressure reading.

    Time frame: Baseline through 3 days postpartum

  4. Proportion of women exceeding 3 days length of stay in hospital after delivery

    Percentage of women that remain hospitalized for more than 3 days following delivery.

    Time frame: Baseline through date of hospital discharge

  5. Median length of stay for hospital readmissions after delivery

    Number of days mothers are readmitted and remain hospitalized after delivery.

    Time frame: Baseline through 90 days postpartum

  6. Proportion of women that attend a follow-up encounter with their primary care physician

    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 365 days postpartum

  7. Proportion of women who receive a nurse home visit

    Percentage of women who receive a nurse home visit within 30 days of discharge

    Time frame: Baseline through 30 days postpartum

  8. Proportion of women eligible for an in-person home visit that received the in-person nurse visit

    Percentage of women eligible for an in-person nurse home visit that received the in-person home visit.

    Time frame: Baseline through 30 days postpartum

  9. Proportion of women eligible for an in-person social work home visit that received the in-person social work visit

    Percentage of women eligible for an in-person social work home visit that received the in-person social work visit

    Time frame: Baseline through 45 days postpartum

  10. Median number of hospital readmissions - Maternal

    Number of hospital readmissions within the first 2 years following delivery

    Time frame: Baseline through 365 days postpartum

  11. Median number of hospital readmissions - Maternal

    Number of hospital readmissions within the first 2 years following delivery

    Time frame: Baseline through 730 days postpartum

  12. Proportion of women scheduled for a mood check provider visit who received a mood check provider visit

    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 21 days postpartum

  13. Proportion of infants that received recommended immunizations

    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 274

  14. Proportion of infants exclusively receiving breastmilk at nurse encounter

    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

  15. Proportion of infants receiving any amount of breastmilk at nurse encounter

    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 21

  16. Median number of hospital readmissions - Infant

    Number of hospital readmissions within the first 2 years following discharge.

    Time frame: Baseline through day 365

  17. Median number of hospital readmissions - Infant

    Number of hospital readmissions within the first 2 years following discharge.

    Time frame: Baseline through day 730

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Oct 2027, 34 months after the start.

Of 151 non-industry interventional studies with no phase under Patient Acceptance of Health Care, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 34 months is above that.

Counting every sponsor, half of 154 studies reached it within 19 months; a quarter within 8 and three quarters within 34.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Jun 2027 → Oct 2027 and completion Dec 2029 → Oct 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2024
First posted
Nov 12, 2024
StartActual
Dec 4, 2024
Primary completionEst.
Oct 2027was Jun 2027
CompletionEst.
Oct 2029was Dec 2029
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 2027→Oct 2027
Sep 28, 2026
Study completion
Dec 2029→Oct 2029
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Primary completion Jun 2027→Oct 2027
    Study completion Dec 2029→Oct 2029
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06682520
Collaborators
The Duke Endowment
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Dec 4, 2024
Primary completion
Oct 2027 (estimated)
Completion
Oct 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Elizabeth T. Jensen, MPH PhD
Contact
elizabeth.jensen@wfusm.edu
336-713-3132
David M. Stamilio, MD, MSCE
Contact
david.stamilio@wfusm.edu
336-716-0271
Elizabeth T. Jensen, MPH PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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