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Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Primary Purpose

Pediatric Disorder, Neonatal Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual family-centered rounds (FCR)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pediatric Disorder focused on measuring Pediatrics, Neonatal Intensive Care Units, Neonate, Clinical Trial, Telemedicine, Patient-Centered Care, Patient Reported Outcome Measures

Eligibility Criteria

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

Enrolling family units (which consists of INFANTS and PARENTS [SURVEYS]): INFANT Inclusion Infants aged less than 365 days who are admitted to the NICU Have at least one adult parent or guardian with English proficiency INFANT Exclusion Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information Infants with a previous NICU admission (and enrollment) during the trial period PARENTS [SURVEYS] Inclusion Parents/guardians of the eligible infants (described above) Age 18 years and older PARENTS [SURVEYS] Exclusion Age less than 18 years Non-English speaking

Sites / Locations

  • The Regents of the University of California, DavisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (Virtual Family-Centered Rounds [FCR])

Control (Usual Care)

Arm Description

Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR.

Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.

Outcomes

Primary Outcome Measures

Parent FCR attendance
Defined at the family unit level, accounting for the possibility of multiple enrolled infants per family and variable lengths of stay for each infant. The investigators will compute the total number of possible weekday FCR encounters per family (the 'denominator') and the number of those for which at least one parent was present virtually or in-person (the 'numerator'). Obtained from FCR weekday observations.

Secondary Outcome Measures

Parent experience
Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).
Family-Centered Care
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Parent Activation
Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Parent health-related quality of life
Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
NICU length of stay
Unit of measure: days in NICU. Obtained from electronic health record.
Breastmilk feeding
Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days).
Postnatal growth failure (dichotomous)
Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record.
Postnatal growth failure (categorical)
Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline </=0.8 SD), mild (>0.8 and </=1.2 SD), moderate (>1.2 and </=2 SD), or severe (>2 SD). Obtained from electronic health record.

Full Information

First Posted
February 17, 2023
Last Updated
June 12, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05762835
Brief Title
Neonatal Intensive Care Unit Virtual Family-Centered Rounds
Official Title
Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
April 12, 2024 (Anticipated)
Study Completion Date
July 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Disorder, Neonatal Disease
Keywords
Pediatrics, Neonatal Intensive Care Units, Neonate, Clinical Trial, Telemedicine, Patient-Centered Care, Patient Reported Outcome Measures

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
447 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Virtual Family-Centered Rounds [FCR])
Arm Type
Experimental
Arm Description
Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR.
Arm Title
Control (Usual Care)
Arm Type
No Intervention
Arm Description
Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.
Intervention Type
Behavioral
Intervention Name(s)
Virtual family-centered rounds (FCR)
Intervention Description
Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).
Primary Outcome Measure Information:
Title
Parent FCR attendance
Description
Defined at the family unit level, accounting for the possibility of multiple enrolled infants per family and variable lengths of stay for each infant. The investigators will compute the total number of possible weekday FCR encounters per family (the 'denominator') and the number of those for which at least one parent was present virtually or in-person (the 'numerator'). Obtained from FCR weekday observations.
Time Frame
Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
Secondary Outcome Measure Information:
Title
Parent experience
Description
Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).
Time Frame
Day 0 (post-NICU discharge)
Title
Family-Centered Care
Description
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Time Frame
Day 0 (post-NICU discharge)
Title
Parent Activation
Description
Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Time Frame
Day 0 (post-NICU discharge)
Title
Parent health-related quality of life
Description
Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
Time Frame
Day 0/30/60/90 (post-NICU discharge)
Title
NICU length of stay
Description
Unit of measure: days in NICU. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Title
Breastmilk feeding
Description
Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days).
Time Frame
Day 0/90 (post-NICU discharge)
Title
Postnatal growth failure (dichotomous)
Description
Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Title
Postnatal growth failure (categorical)
Description
Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline </=0.8 SD), mild (>0.8 and </=1.2 SD), moderate (>1.2 and </=2 SD), or severe (>2 SD). Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Other Pre-specified Outcome Measures:
Title
Neonatal growth velocity
Description
Continuous variable. Measure/Tool: Sex-specific Fenton growth charts. Calculate change in Z-score divided by number of days in the NICU. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Title
Adverse events and errors
Description
Include the rates of harmful errors, non-harmful errors, and overall errors (harmful errors plus non-harmful errors). Obtained via review of data from electronic health record, incident report system, and solicited reports. Two neonatologists, blinded to the study arm, will independently categorize each event as a harmful error (preventable adverse event), non-harmful error, non-preventable adverse event, or exclusion.
Time Frame
Day 0 (post-NICU discharge)
Title
30-day revisit
Description
Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.
Time Frame
Day 30 (post-NICU discharge)
Title
30-day readmission
Description
Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.
Time Frame
Day 30 (post-NICU discharge)
Title
Temperature instability
Description
Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Title
Central line-associated bloodstream infection
Description
Dichotomous variable defined as any occurrence during the NICU hospitalization of a laboratory-confirmed bacterial or viral bloodstream infection that develops with a central line in place and is not related to an infection at another site. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Title
Central line days
Description
Number of days among the total number of NICU days that the infant has an umbilical catheter or one or more central lines in place. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)
Title
Antibiotic days
Description
Number of days among the total number of NICU days that the infant receives intramuscular or intravascular antibacterial or antifungal agents. Obtained from electronic health record.
Time Frame
Day 0 (post-NICU discharge)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Enrolling family units (which consists of INFANTS and PARENTS [SURVEYS]): INFANT Inclusion Infants aged less than 365 days who are admitted to the NICU Have at least one adult parent or guardian with English proficiency INFANT Exclusion Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information Infants with a previous NICU admission (and enrollment) during the trial period PARENTS [SURVEYS] Inclusion Parents/guardians of the eligible infants (described above) Age 18 years and older PARENTS [SURVEYS] Exclusion Age less than 18 years Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Rosenthal, MD, MAS
Phone
9167344719
Email
rosenthal@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elva Horath
Phone
9168482005
Email
hs-telepeds@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Rosenthal, MD, MAS
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Regents of the University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contracts and Grants Analyst

12. IPD Sharing Statement

Learn more about this trial

Neonatal Intensive Care Unit Virtual Family-Centered Rounds

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