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| Name | Class |
|---|---|
| The Duke Endowment | OTHER |
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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,
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum NEST-Rural Program Group | Experimental | Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following NEST-Rural Program:
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| Postpartum Usual Care Group | No Intervention | Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postpartum NEST-Rural Program (Hospital based service model) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median number of hospital readmissions - Maternal | Number of hospital readmissions in the 4th trimester | Baseline through 30 days postpartum |
| Median number of hospital readmissions - Maternal | Number of hospital readmissions in the 4th trimester | Baseline through 90 days postpartum |
| Median number of encounters for urgent or emergent care - Maternal | 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 | 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 | Percentage of women that attended recommended visits to their obstetrician after delivery. | Baseline through 90 days postpartum |
| Median number of hospital readmissions - Infant | Number of hospital readmissions after birth following hospital discharge. | Baseline through 30 days postpartum |
| Median number of hospital readmissions - Infant | Number of hospital readmissions after birth following hospital discharge. | Baseline through 90 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 21 days postpartum |
| Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth T. Jensen, MPH PhD | Contact | 336-713-3132 | elizabeth.jensen@wfusm.edu | |
| David M. Stamilio, MD, MSCE | Contact | 336-716-0271 | david.stamilio@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth T. Jensen, MPH PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Randomization to one of two study arms: Postpartum Standard of Care (Control arm). Postpartum NEST-Rural Program Service model (Experimental arm).
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| Median number of encounters for urgent or emergent care - Infant | 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 | 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 | 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 | 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 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Number of hospital readmissions within the first 2 years following delivery | Baseline through 365 days postpartum |
| Median number of hospital readmissions - Maternal | 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 | 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 | 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 | 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 | 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 | Number of hospital readmissions within the first 2 years following discharge. | Baseline through day 365 |
| Median number of hospital readmissions - Infant | Number of hospital readmissions within the first 2 years following discharge. | Baseline through day 730 |