Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
1 other identifier
interventional
840
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2019
CompletedFirst Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedApril 4, 2023
March 1, 2023
3 years
March 6, 2019
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Child Emergency Room Presentation Rates
As reported in hospital administrative records and reported by parent.
Program enrollment until 24 months of Child Age.
Mother Emergency Room Presentation Rates
As reported in hospital administrative records and self report.
Program enrollment until 24 months postnatal.
Child Hospital Admissions
As reported in hospital administrative records and reported by parent.
Program enrollment until 24 months postnatal.
Mother Hospital Admissions
As reported in hospital administrative records and self report.
Program enrollment until 24 months postnatal.
Secondary Outcomes (8)
Mother Postnatal Well-Care Compliance Rates
Program enrollment until 24 months postnatal.
Child Postnatal Well-Care Compliance Rates
Program enrollment until 24 months postnatal.
Mother Mental Health - Anxiety Rates
Program enrollment until 24 months postnatal.
Mother Mental Health - Depression Rates
Program enrollment until 24 months postnatal.
Family Connections to Community Services/Resources
Program enrollment until 7 months postnatal.
- +3 more secondary outcomes
Study Arms (3)
Enhanced Intervention
EXPERIMENTALNorthwell Health Visits postnatal Nurse Practitioner home visitation program and referrals and developmental toys.
Intervention
EXPERIMENTALNorthwell Health Visits postnatal Nurse Practitioner home visitation program and developmental screening and parent guides only.
Control
NO INTERVENTIONUsual care with developmental toys.
Interventions
Participants randomized to the Enhanced Intervention group will receive the Family Connects program, an evidence- based structure that begins at the birthing hospital stay, followed by 1 to 3 nurse home visits between 4 to 12 weeks of infant age, a follow-up contact one month later and a discharge home visit six months later and a final follow-up contact one month after that. During the home visits, the nurse engages with the mother and completes a holistic health and psychosocial assessment, during which the unique risks and family needs across 12 family domains are evaluated and addressed with either referrals with matched community resources or thorough education. In addition, they will be given a set of six developmental toys.
Participants randomized to the Intervention group will receive the Family Connects program, an evidence- based structure that begins at the birthing hospital stay, followed by 1 to 3 nurse home visits between 4 to 12 weeks of infant age, a follow-up contact one month later and a discharge home visit six months later and a final follow-up contact one month after that. During the home visits, the nurse engages with the mother and completes a holistic health and psychosocial assessment, during which the unique risks and family needs across 12 family domains are evaluated. For each screened domain, the nurse is able to systematically address them, which may result in an immediate intervention; either referrals with matched community resources or thorough education.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Loss of Pregnancy
- Fetal demise
- No health insurance
- Infant in neonatal intensive care unit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
Northwell Health
Manhasset, New York, 11030-3802, United States
Related Publications (1)
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.
PMID: 34286512DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Principal Investigator, Co-Investigator and Outcomes Assessors are Masked
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 25, 2019
Study Start
January 9, 2019
Primary Completion
January 1, 2022
Study Completion
October 31, 2022
Last Updated
April 4, 2023
Record last verified: 2023-03