跳至主要内容
临床试验/NCT03887910
NCT03887910已完成不适用

Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health

Northwell Health2 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2019年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
840
试验地点
2
主要终点
Mother Emergency Room Presentation Rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Principal Investigator, Co-Investigator and Outcomes Assessors are Masked

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Mother Emergency Room Presentation Rates

时间窗: Program enrollment until 24 months postnatal.

As reported in hospital administrative records and self report.

Mother Hospital Admissions

时间窗: Program enrollment until 24 months postnatal.

As reported in hospital administrative records and self report.

Child Emergency Room Presentation Rates

时间窗: Program enrollment until 24 months of Child Age.

As reported in hospital administrative records and reported by parent.

Child Hospital Admissions

时间窗: Program enrollment until 24 months postnatal.

As reported in hospital administrative records and reported by parent.

次要结局

  • Family Connections to Community Services/Resources(Program enrollment until 7 months postnatal.)
  • Mother parenting behaviors(Program enrollment until 24 months postnatal.)
  • Mother Mental Health - Anxiety Rates(Program enrollment until 24 months postnatal.)
  • Child Postnatal Well-Care Compliance Rates(Program enrollment until 24 months postnatal.)
  • Mother Postnatal Well-Care Compliance Rates(Program enrollment until 24 months postnatal.)
  • Mother alcohol and other drug abuse(Program enrollment until 24 months postnatal.)
  • Family Violence(Program enrollment until 24 months postnatal.)
  • Mother Mental Health - Depression Rates(Program enrollment until 24 months postnatal.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验