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

Primary Purpose

Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Intervention
Intervention
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Unspecified Child Maltreatment, Suspected focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwell Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Enhanced Intervention

Intervention

Control

Arm Description

Northwell Health Visits postnatal Nurse Practitioner home visitation program and referrals and developmental toys.

Northwell Health Visits postnatal Nurse Practitioner home visitation program and developmental screening and parent guides only.

Usual care with developmental toys.

Outcomes

Primary Outcome Measures

Child Emergency Room Presentation Rates
As reported in hospital administrative records and reported by parent.
Mother Emergency Room Presentation Rates
As reported in hospital administrative records and self report.
Child Hospital Admissions
As reported in hospital administrative records and reported by parent.
Mother Hospital Admissions
As reported in hospital administrative records and self report.

Secondary Outcome Measures

Mother Postnatal Well-Care Compliance Rates
Rates of mother compliance with postnatal well-care, self reported and found on hospital records.
Child Postnatal Well-Care Compliance Rates
Rates of infant compliance with postnatal well-care health checks as reported by mother and found on hospital records.
Mother Mental Health - Anxiety Rates
Rates of postpartum anxiety symptoms as reported by mother. Assessed with General Anxiety Disorder-7 (GAD-7). Generalized Anxiety Disorder 7-Item (GAD-7) Scale Over the last 2 weeks, how often have you been bothered by the following problems? Feeling nervous, anxious, or on edge Not being able to stop or control worrying Worrying too much about different things Trouble relaxing Being so restless that it's hard to sit still Becoming easily annoyed or irritable Feeling afraid as if something awful might happen Score each with the following options: Not at all (0) Several days (1) More than half the days (2) Nearly every day (3) Scoring Criteria: Total score (adding all the numbers) provides a possible score from 0-21. GAD-7 Total Score Symptom Range 0-4 Minimal Anxiety 5-9 Mild Anxiety 10-14 Moderate Anxiety 15-21 Severe Anxiety
Mother Mental Health - Depression Rates
Rates of postpartum depression symptoms as reported by mother. Assessed with Edinburgh Postnatal Depression Scale (EPDS). SCORING QUESTIONS 1, 2, & 4 (without an *) Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. QUESTIONS 3, 510 (marked with an *) Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts)
Family Connections to Community Services/Resources
Rates of family connections to community resources and services as reported by the mother.
Mother parenting behaviors
Rates of mother positive and negative parenting behaviors as reported by mother.
Mother alcohol and other drug abuse
Rates of mother alcohol and other drug abuse as reported by mother and assessed using CAGE-AID screening tool. The CAGE questionnaire is used to test for alcohol abuse and dependence in adults. The CAGEAID version of the tool has been adapted to include drug use. Item responses on the CAGE and CAGE-AID are scored 0 or 1, with a higher score indicating alcohol or drug use problems. Each affirmative response earns one point. One point indicates a possible problem. Two points indicate a probable problem. 2/4 or greater = positive CAGE, further evaluation is indicated.
Family Violence
Rates of family violence as assessed using the Conflict Tactics Scale (CTS). Instructions: Please check the answer that best describes your relationship with your partner in the past year? The CTS is scored by adding the midpoints for the response categories chosen by the participant. The midpoints are the same as the response category numbers for Categories 0, 1, and 2. For Category 3 (3-5 times) the midpoint is 4, for Category 4 (6- or more times) it is 8. A score of 0 is negative for family violence,higher scores are indicative of greater physical abuse

Full Information

First Posted
March 6, 2019
Last Updated
March 31, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT03887910
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Principal Investigator, Co-Investigator and Outcomes Assessors are Masked
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Intervention
Arm Type
Experimental
Arm Description
Northwell Health Visits postnatal Nurse Practitioner home visitation program and referrals and developmental toys.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Northwell Health Visits postnatal Nurse Practitioner home visitation program and developmental screening and parent guides only.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care with developmental toys.
Intervention Type
Other
Intervention Name(s)
Enhanced Intervention
Other Intervention Name(s)
Family Connects Plus Developmental Toys
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention
Other Intervention Name(s)
Family Connects
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child Emergency Room Presentation Rates
Description
As reported in hospital administrative records and reported by parent.
Time Frame
Program enrollment until 24 months of Child Age.
Title
Mother Emergency Room Presentation Rates
Description
As reported in hospital administrative records and self report.
Time Frame
Program enrollment until 24 months postnatal.
Title
Child Hospital Admissions
Description
As reported in hospital administrative records and reported by parent.
Time Frame
Program enrollment until 24 months postnatal.
Title
Mother Hospital Admissions
Description
As reported in hospital administrative records and self report.
Time Frame
Program enrollment until 24 months postnatal.
Secondary Outcome Measure Information:
Title
Mother Postnatal Well-Care Compliance Rates
Description
Rates of mother compliance with postnatal well-care, self reported and found on hospital records.
Time Frame
Program enrollment until 24 months postnatal.
Title
Child Postnatal Well-Care Compliance Rates
Description
Rates of infant compliance with postnatal well-care health checks as reported by mother and found on hospital records.
Time Frame
Program enrollment until 24 months postnatal.
Title
Mother Mental Health - Anxiety Rates
Description
Rates of postpartum anxiety symptoms as reported by mother. Assessed with General Anxiety Disorder-7 (GAD-7). Generalized Anxiety Disorder 7-Item (GAD-7) Scale Over the last 2 weeks, how often have you been bothered by the following problems? Feeling nervous, anxious, or on edge Not being able to stop or control worrying Worrying too much about different things Trouble relaxing Being so restless that it's hard to sit still Becoming easily annoyed or irritable Feeling afraid as if something awful might happen Score each with the following options: Not at all (0) Several days (1) More than half the days (2) Nearly every day (3) Scoring Criteria: Total score (adding all the numbers) provides a possible score from 0-21. GAD-7 Total Score Symptom Range 0-4 Minimal Anxiety 5-9 Mild Anxiety 10-14 Moderate Anxiety 15-21 Severe Anxiety
Time Frame
Program enrollment until 24 months postnatal.
Title
Mother Mental Health - Depression Rates
Description
Rates of postpartum depression symptoms as reported by mother. Assessed with Edinburgh Postnatal Depression Scale (EPDS). SCORING QUESTIONS 1, 2, & 4 (without an *) Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. QUESTIONS 3, 510 (marked with an *) Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts)
Time Frame
Program enrollment until 24 months postnatal.
Title
Family Connections to Community Services/Resources
Description
Rates of family connections to community resources and services as reported by the mother.
Time Frame
Program enrollment until 7 months postnatal.
Title
Mother parenting behaviors
Description
Rates of mother positive and negative parenting behaviors as reported by mother.
Time Frame
Program enrollment until 24 months postnatal.
Title
Mother alcohol and other drug abuse
Description
Rates of mother alcohol and other drug abuse as reported by mother and assessed using CAGE-AID screening tool. The CAGE questionnaire is used to test for alcohol abuse and dependence in adults. The CAGEAID version of the tool has been adapted to include drug use. Item responses on the CAGE and CAGE-AID are scored 0 or 1, with a higher score indicating alcohol or drug use problems. Each affirmative response earns one point. One point indicates a possible problem. Two points indicate a probable problem. 2/4 or greater = positive CAGE, further evaluation is indicated.
Time Frame
Program enrollment until 24 months postnatal.
Title
Family Violence
Description
Rates of family violence as assessed using the Conflict Tactics Scale (CTS). Instructions: Please check the answer that best describes your relationship with your partner in the past year? The CTS is scored by adding the midpoints for the response categories chosen by the participant. The midpoints are the same as the response category numbers for Categories 0, 1, and 2. For Category 3 (3-5 times) the midpoint is 4, for Category 4 (6- or more times) it is 8. A score of 0 is negative for family violence,higher scores are indicative of greater physical abuse
Time Frame
Program enrollment until 24 months postnatal.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34286512
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.
Results Reference
derived

Learn more about this trial

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

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