Using NICU Discharge Education Tools to Enhance Discharge Preparation for Parents of Moderate to Late Preterm Infants

NCT06177951 | Enrolling By Invitation

• 1 other identifier: 23-0490
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to improve the transition to home for preterm infants born between 33-36 weeks gestational age and discharged from the neonatal intensive care unit (NICU) through the use of two interventions, a "NICU Discharge Passport" and "NICU Infant Care Class," for parents. The main question\[s\] the clinical trial aims to answer are the impact of the above discharge interventions on:

• parental readiness for discharge
• feasibility of compliance with discharge instructions
• number of ER/urgent visits and hospital re-admission rates 1-month post-discharge Participants will include parents/guardians and nurses of eligible preterm infants discharged from the Cohen Children's Medical Center NICU. Baseline data will be collected for a period of 4-6 months for a control group (who will receive current NICU discharge practices), after which two interventions will be implemented for a period of 4-6 months to the intervention groups. Interventions will include: a) NICU Discharge Passport and b) NICU Infant Care Class. Data collection will include pre and post-discharge surveys for parent and nurse participants in charge of discharging the eligible infant participant. Surveys will assess parental readiness for discharge, compliance with discharge instructions, ER/urgent visits post-discharge, hospital re-admission rates post-discharge, and if applicable, obtain feedback on interventions. Researchers will compare responses between control and intervention groups to understand the impact of the interventions on parental discharge preparedness.

Conditions

Discharge Readiness

Outcome Measures

Primary Outcomes (1)

• Parental Readiness for Hospital Discharge

  Parental readiness for discharge will be assessed through survey questions administered to both nurse and parent participants. Parent participants will answer the questions pre-discharge and 1-month post-discharge. Nurse participants will answer the questions pre-discharge. The survey will consist of 10 questions on a Likert scale (responses are assigned numerical points which will be summed to obtain a readiness score). The questions will assess parental confidence, preparation, knowledge, and support at home in regards to discharge with their infant.

  Pre-discharge, 1-month Post-discharge

Secondary Outcomes (3)

• Number of ER/Urgent Visits

  1-month Post-Discharge

• Hospital Re-admission Rates

  1-month Post-Discharge

• Adherence to Discharge Instructions

  1-month Post-Discharge

Study Arms (4)

Control Group

NO INTERVENTION

This group will receive neither of the interventions (NICU Discharge Passport, NICU Infant Care Class).

Received NICU Discharge Passport Only

EXPERIMENTAL

This group will receive only one intervention: NICU Discharge Passport.

Other: NICU Discharge Passport

Received NICU Infant Care Class Only

EXPERIMENTAL

This group will receive only one intervention: NICU Infant Care Class.

Other: NICU Infant Care Class

Received Both NICU Discharge Passport and NICU Infant Care Class

EXPERIMENTAL

This group will receive both interventions: NICU Discharge Passport, NICU Infant Care Class.

Other: NICU Discharge Passport; Other: NICU Infant Care Class

Interventions

NICU Discharge Passport OTHER

The NICU discharge passport contains a discharge checklist highlighting important "go-to" information for infants (feeding plan, medications, pharmacy information, pediatrician, and follow ups post-discharge). It also provides key anticipatory guidance for newborns.

Received Both NICU Discharge Passport and NICU Infant Care Class; Received NICU Discharge Passport Only

NICU Infant Care Class OTHER

The class will be provided once or twice weekly to eligible study participants. It will be conducted in a small group format. Class teachers will focus on providing key anticipatory guidance to aid in the transition home during the first month of life . Topics related to infant care will be discussed, including feeding, elimination, skincare, hygiene, soothing, development, and when to see a doctor/emergencies.

Received Both NICU Discharge Passport and NICU Infant Care Class; Received NICU Infant Care Class Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent and/or legal guardian of all preterm infants born at a gestational age (GA) between 33 weeks and 0 days, and 36 weeks and 6 days, at Cohen Children's Medical Center (CCMC) that will be admitted to and discharged from the NICU will be included in this study.
• A maximum of one parent/guardian for each eligible infant will be included in the study.
• Twin infants will be treated as separate study subjects.
• The nurse in charge of discharging the eligible infant will be included in the study.

You may not qualify if:

• Parents of infants not being discharged to home from CCMC NICU (ie discharged to rehab and/or other facilities).
• NICU patients with a diagnosis of congenital heart disease requiring intervention during current admission (This is due to the fact that these patients already have specific discharge instructions/transition plan(s) in place).
• Parents/guardians that are Non-English speaking will be excluded from the study due to the inability of the current study to provide all interventions in non-English languages.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cohen Children's Medical Center

Queens, New York, 11040, United States

Location

Study Officials

• Katherine Sullivan, MD

  ksullivan14@northwell.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 8, 2024
• Primary Completion: September 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)