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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05762835
Other study ID # 1234567890
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date July 12, 2024

Study information

Verified date June 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 486
Est. completion date July 12, 2024
Est. primary completion date April 12, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Behavioral:
Virtual family-centered rounds (FCR)
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).

Locations

Country Name City State
United States The Regents of the University of California, Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Neonatal growth velocity 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. Day 0 (post-NICU discharge)
Other Adverse events and errors 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. Day 0 (post-NICU discharge)
Other 30-day revisit Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey. Day 30 (post-NICU discharge)
Other 30-day readmission Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey. Day 30 (post-NICU discharge)
Other Temperature instability Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record. Day 0 (post-NICU discharge)
Other Central line-associated bloodstream infection 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. Day 0 (post-NICU discharge)
Other Central line days 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. Day 0 (post-NICU discharge)
Other Antibiotic days 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. Day 0 (post-NICU discharge)
Primary 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. Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
Secondary 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). Day 0 (post-NICU discharge)
Secondary Family-Centered Care Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey) Day 0 (post-NICU discharge)
Secondary Parent Activation Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey) Day 0 (post-NICU discharge)
Secondary Parent health-related quality of life Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey) Day 0/30/60/90 (post-NICU discharge)
Secondary NICU length of stay Unit of measure: days in NICU. Obtained from electronic health record. Day 0 (post-NICU discharge)
Secondary 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). Day 0/90 (post-NICU discharge)
Secondary 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. Day 0 (post-NICU discharge)
Secondary 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 Day 0 (post-NICU discharge)
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