FamilyLink Family-Centered Rounds

Family Centered Rounds Clinical Trial

Official title:

FamilyLink Family-Centered Rounds Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265677
• Other study ID #: 1524392
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: March 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Family Centered Rounds

Intervention

Other:
• Telemedicine FCR
Parents/guardians will be able to join family centered rounds using telemedicine (audio and visual)
• Standard of care
Parents/guardians will not be able to join family centered rounds using telemedicine (audio and visual)

Locations

Country	Name	City	State
United States	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
Primary	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	Rates of adverse events	Rates of adverse events reported by parents, providers, or nurses	Up to 6 months
Secondary	Hospital Length of Stay	Hospital length of stay of the patient measured in days	Through study completion, approximately 3 months
Secondary	Breastmilk at discharge	If the patient was receiving all, some or no breastmilk	Through study completion, approximately 3 months