Clinical trial NCT03887910: Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Official title: Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Child Maltreatment, Suspected
Unspecified Child Maltreatment, Confirmed
Postpartum Depression
Keywords: Postpartum Nurse Home Visitation
Infant Emergency Medical Care Presentations
Mother Emergency Medical Care Presentations
Parent-Child Relationship Quality
Family Connections to Community Resources
Child Development and Milestone Achievement
Maternal Mental Health
Child Abuse
Child Neglect
Child Well-Care Compliance
Mother Well-Care Compliance
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 840
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.

Detailed description: Northwell Health Visits (NHV) is based on Family Connects (formerly Durham Connects), which is a short-term, universal, inexpensive postnatal nurse home visiting program designed to provide brief parenting intervention and to connect families with community resources based on individualized assessments of family needs. The intervention was found to reduce the number of infant emergency medical care episodes and rates of anxiety in mothers, as well as increase community connection, positive parenting behaviors, participation in higher quality out-of-home child care when implemented in Durham, so we are looking to replicate these outcomes. We are adapting the model to serve the local population that is served by Northwell Health - Katz Women's Hospital at Long Island Jewish (LIJ) Medical Center, to see if increasing services in and around discharge is more useful for mothers and infants, and improves outcomes for infants. The focus is of early intervention (education and support by Nurse Practitioner), and connection to community agencies, in order to: reduce healthcare costs, decrease the rate of mothers and infants Potentially Preventable Emergency Room Visits (PPVs), adhere to well-baby care and mother's postpartum care schedules, improve family functioning, strengthen family partnerships and well-being, reduce necessary reports to child protective services, improve mental and physical health outcomes of mothers and infants within the first six months of life.

Eligibility criteria: Inclusion Criteria:

* Infant Born at Katz Women's Hospital at Long Island Jewish (LIJ) Medical Center
* Mother Age 18 years or older
* Mother who has delivered a single live born normal infant, vaginally or by cesarean section
* Mother Primary Language Spoken is English

Exclusion Criteria:

* Loss of Pregnancy
* Fetal demise
* No health insurance
* Infant in neonatal intensive care unit

Primary outcomes:
measure: Child Emergency Room Presentation Rates
timeFrame: Program enrollment until 24 months of Child Age.
measure: Mother Emergency Room Presentation Rates
timeFrame: Program enrollment until 24 months postnatal.
measure: Child Hospital Admissions
timeFrame: Program enrollment until 24 months postnatal.
measure: Mother Hospital Admissions
timeFrame: Program enrollment until 24 months postnatal.
Secondary outcomes:
measure: Mother Postnatal Well-Care Compliance Rates
timeFrame: Program enrollment until 24 months postnatal.
measure: Child Postnatal Well-Care Compliance Rates
timeFrame: Program enrollment until 24 months postnatal.
measure: Mother Mental Health - Anxiety Rates
timeFrame: Program enrollment until 24 months postnatal.
measure: Mother Mental Health - Depression Rates
timeFrame: Program enrollment until 24 months postnatal.
measure: Family Connections to Community Services/Resources
timeFrame: Program enrollment until 7 months postnatal.
measure: Mother parenting behaviors
timeFrame: Program enrollment until 24 months postnatal.
measure: Mother alcohol and other drug abuse
timeFrame: Program enrollment until 24 months postnatal.
measure: Family Violence
timeFrame: Program enrollment until 24 months postnatal.
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health
state: New York
Study officials:
References:
citation: Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.