Discharge ReadinessNCT06177951
Using NICU Discharge Education Tools to Enhance Discharge Preparation for Parents of Moderate to Late Preterm Infants
A study testing NICU Discharge Passport and NICU Infant Care Class in people with Discharge Readiness, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Discharge Readiness
- What is being tested?
- NICU Discharge Passport and NICU Infant Care Class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cohen Children's Medical Center
Queens, New York, 11040
About this study
Official title: Improving the Transition to Home for Moderate to Late Preterm Infants Admitted to the NICU Through Parent Education and Discharge Preparation
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:
Read more
- 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.
Read the detailed description
Currently, parents of 33-36 weeks gestational age neonates discharged from the NICU receive discharge-related information, including feeding plan, medications, follow up appointments, and more, from their discharge summary completed in the electronic medical record. This moderate to late preterm population is a unique transitory preterm population in the NICU because while these infants do not face the same risk of medical complications as their younger counterparts, they do require more focused management for very specific risks of prematurity, including poor oromotor skills, glycemic control, thermoregulation, and immature development. Furthermore, much of their short admission period in the NICU is spent in both the management of these concerns and the provision of parental education and support for the same.
The objective of this study is to improve the transition to home for 33-36 weeks gestational age preterm infants discharged from the NICU through the use of a specific "NICU Discharge Passport" and "NICU Infant Care Class" for parents. The study hypothesis is that these interventions will improve parental discharge preparedness.
Study 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, consisting of a discharge checklist and key anticipatory guidance for newborns and b) NICU Infant Care Class, provided in person weekly to all eligible study participants.
Data collection will include surveys for parents and nurses. Parents will complete a total of 2 surveys (one before discharge from the hospital, the second at a 1-month follow up survey via telephone). Nurses will complete 1 survey before discharge of the infant participant from the NICU. Survey details: The pre-discharge survey will be administered to both parents and nurses, and assess parental readiness for discharge home with their child. In addition, for parents receiving the interventions, the pre-discharge survey will obtain feedback regarding the interventions. The pre-discharge survey will be completed within the 5-day period leading up to discharge once the infant is identified by the medical team as a discharge candidate. One month post discharge from the hospital, a follow up phone call survey will be obtained from all parents participating in the study. The post-discharge survey will again assess parental readiness for discharge home with their child. It will also collect information on parental self-report on the transition home from the NICU, including any barriers encountered. Researchers will compare survey responses between control and intervention groups.
- Conditions
- Discharge Readiness
- Being tested
- NICU Discharge Passport, NICU Infant Care Class
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICU Discharge PassportOther
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.
NICU Infant Care ClassOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NICU Discharge Passport |
| Received NICU Infant Care Class Only | Experimental | This group will receive only one intervention: NICU Infant Care Class. Receives: 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. Receives: Other: NICU Discharge Passport; Other: NICU Infant Care Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-discharge, 1-month Post-discharge
Secondary outcomes (3)
Number of ER/Urgent Visits
At follow up survey, 1-month post-discharge from the hospital, parent participants will be asked how many ER and/or urgent visits they have had since leaving the NICU.
Measured: 1-month Post-Discharge
Hospital Re-admission Rates
At follow up survey, 1-month post-discharge from the hospital, parent participants will be asked if their child has required re-admission since discharge from the NICU.
Measured: 1-month Post-Discharge
Adherence to Discharge Instructions
At follow up survey, 1-month post-discharge from the hospital, parent participants will be asked how feasible it has been to follow their baby's discharge plan, including feeding instructions, practicing safe sleep, administering medications, and following up with their pediatrician.
Measured: 1-month Post-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start8 Jan 2024
- Primary completion8 Sep 2024 (estimated)
- Study completion8 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discharge ReadinessStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Sullivan, MD, Principal investigator, ksullivan14@northwell.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177951
- Sponsor's protocol ID
- 23-0490
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Transition to Home for Moderate to Late Preterm Infants Admitted to the NICU Through Parent Education and Discharge Preparation
- ClinicalTrials.gov ID
- NCT06177951
- Acronym / sponsor ID
- 23-0490
- Conditions
- Discharge Readiness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Sep 2024 (estimated)
- Study completion
- 8 Oct 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, parents of 33-36 weeks gestational age neonates discharged from the NICU receive discharge-related information, including feeding plan, medications, follow up appointments, and more, from their discharge summary completed in the electronic medical record. This moderate to late preterm population is a unique transitory preterm population in the NICU because while these infants do not face the same risk of medical complications as their younger counterparts, they do require more focused management for very specific risks of prematurity, including poor oromotor skills, glycemic control, thermoregulation, and immature development. Furthermore, much of their short admission period in the NICU is spent in both the management of these concerns and the provision of parental education and support for the same.
The objective of this study is to improve the transition to home for 33-36 weeks gestational age preterm infants discharged from the NICU through the use of a specific "NICU Discharge Passport" and "NICU Infant Care Class" for parents. The study hypothesis is that these interventions will improve parental discharge preparedness.
Study 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, consisting of a discharge checklist and key anticipatory guidance for newborns and b) NICU Infant Care Class, provided in person weekly to all eligible study participants.
Data collection will include surveys for parents and nurses. Parents will complete a total of 2 surveys (one before discharge from the hospital, the second at a 1-month follow up survey via telephone). Nurses will complete 1 survey before discharge of the infant participant from the NICU. Survey details: The pre-discharge survey will be administered to both parents and nurses, and assess parental readiness for discharge home with their child. In addition, for parents receiving the interventions, the pre-discharge survey will obtain feedback regarding the interventions. The pre-discharge survey will be completed within the 5-day period leading up to discharge once the infant is identified by the medical team as a discharge candidate. One month post discharge from the hospital, a follow up phone call survey will be obtained from all parents participating in the study. The post-discharge survey will again assess parental readiness for discharge home with their child. It will also collect information on parental self-report on the transition home from the NICU, including any barriers encountered. Researchers will compare survey responses between control and intervention groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: NICU Discharge PassportThis group will receive only one intervention: NICU Discharge Passport. |
| Received NICU Infant Care Class Only | Experimental | Other: NICU Infant Care ClassThis group will receive only one intervention: NICU Infant Care Class. |
| Received Both NICU Discharge Passport and NICU Infant Care Class | Experimental | Other: NICU Discharge Passport, Other: NICU Infant Care ClassThis group will receive both interventions: NICU Discharge Passport, NICU Infant Care Class. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICU Discharge PassportThe 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. | Other | Received Both NICU Discharge Passport and NICU Infant Care Class, Received NICU Discharge Passport Only |
| NICU Infant Care ClassThe 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. | Other | Received Both NICU Discharge Passport and NICU Infant Care Class, Received NICU Infant Care Class Only |
Primary outcome
Parental Readiness for Hospital Discharge
Time frame: Pre-discharge, 1-month Post-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.
3 secondary outcomes
Number of ER/Urgent Visits
Time frame: 1-month Post-Discharge
Hospital Re-admission Rates
Time frame: 1-month Post-Discharge
Adherence to Discharge Instructions
Time frame: 1-month Post-Discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Sullivan, MD principal investigator
ksullivan14@northwell.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICU Discharge Passport and NICU Infant Care Class in people with Discharge Readiness, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Readiness for Hospital Discharge (time frame: Pre-discharge, 1-month Post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.