FamilyLink Family-Centered Rounds

FamilyLink Family-Centered Rounds Pilot Study

This study will be a pilot test of using FamilyLink software to bring parents of patients in the neonatal intensive care unit (NICU) virtually to the bedside during Family Centered Rounds.

Study Overview

• Status: Completed
• Conditions: Family Centered Rounds
• Intervention / Treatment: Other: Telemedicine FCR; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California-Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients admitted to the Blue Team in the NICU aged 0-365 days
• Parents/guardians of patients admitted to the Blue Team in the NICU aged ≥ 18 years
• Medical team members (physicians, nurse practitioners, fellows, residents, medical students, nurses) of patients admitted to the Blue Team in the NICU aged ≥ 18 years

Exclusion Criteria:

• Patients who are not discharged home from the NICU (e.g., transferred to another inpatient unit or another hospital)
• Parents/guardians of patients admitted to the Blue Team in the NICU who do not speak English, as a translator will not reliability be available to participate in rounds when the parent/guardian is not physically present
• Patients who have more than one admission to the Blue Team during our study period will only be included on their first admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine FCR; These patients will be eligible to use telemedicine for Family Centered Rounds	Other: Telemedicine FCR; Parents/guardians will be able to join family centered rounds using telemedicine (audio and visual)
Placebo Comparator: Control; These patients will not be eligible to use telemedicine for Family Centered Rounds (standard of care)	Other: Standard of care; Parents/guardians will not be able to join family centered rounds using telemedicine (audio and visual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAHPS Communication with Parent Subscale	19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure). Higher scores are better; 0 (minimum) - 100 (maximum)	Through study completion, approximately 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of adverse events	Rates of adverse events reported by parents, providers, or nurses	Up to 6 months
Hospital Length of Stay	Hospital length of stay of the patient measured in days	Through study completion, approximately 3 months
Breastmilk at discharge	If the patient was receiving all, some or no breastmilk	Through study completion, approximately 3 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1524392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No