FamilyLink Family-Centered Rounds

NCT04265677 | Completed

• 1 other identifier: 1524392
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Family Centered Rounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rates of adverse events

  Up to 6 months

• Hospital Length of Stay

  Through study completion, approximately 3 months

• Breastmilk at discharge

  Through study completion, approximately 3 months

Study Arms (2)

Telemedicine FCR

EXPERIMENTAL

These patients will be eligible to use telemedicine for Family Centered Rounds

Other: Telemedicine FCR

Control

PLACEBO COMPARATOR

These patients will not be eligible to use telemedicine for Family Centered Rounds (standard of care)

Other: Standard of care

Interventions

Telemedicine FCR OTHER

Parents/guardians will be able to join family centered rounds using telemedicine (audio and visual)

Telemedicine FCR

Standard of care OTHER

Parents/guardians will not be able to join family centered rounds using telemedicine (audio and visual)

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: April 1, 2020
• Primary Completion: November 23, 2020
• Study Completion: February 2, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)