Virtual Family Participation in ICU Rounds: A Pilot Study

Not Applicable

Completed

• Conditions: Critical Care; Virtual; Family Engagement
• Interventions: Other: Participation in virtual rounds

• Registration Number: NCT05891860
• Lead Sponsor: Lady Davis Institute

Brief Summary

Barriers to family participation in ICU rounds exist at the health care system level (e.g., restriction on visitation, infection control) and the individual level (e.g., caretaker role, illness, disability, inability to miss work). While virtual family participation in ICU rounds may contribute to addressing these barriers, its feasibility, impact, and effectiveness are yet unknown. The primary objective of this study is to assess the feasibility of virtual family participation in adult ICU rounds. The secondary objectives are: to assess the effect size of virtual family participation in ICU rounds on family engagement, satisfaction, and anxiety and depression; and to explore family and physician experiences of family participation in ICU rounds.

This will be a pilot prospective trial of 72 family members at 4 Canadian adult ICUs, with an embedded qualitative study that will sample family members and critical care physicians. The primary outcome will reflect feasibility metrics (i.e., recruitment, uptake, technical, and follow-up). Secondary outcomes include data regarding family engagement, satisfaction, mental health, and perceived experiences of participation in ICU rounds. This study will assess the feasibility of conducting a larger, hypothesis-testing randomized controlled trial to assess virtual family participation in adult ICU rounds.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-07
• Study Start: 2023-06-12
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Family member of ICU patient with expected ICU stay > 48 hours (as per treating team)
• Age ≥ 18 years old
• Willing and able to participate in virtual ICU rounds
• Ability to communicate in English or French
• Able: technological capability and understanding to participate virtually in ICU rounds (must have a phone or computer with internet and audio/video capabilities).
• "Family member" is anyone with a biological, legal, or emotional relationship with the patient.

Exclusion criteria

• Intends to participate in in-person rounds (if available and offered at participating site)
• Another family member already participating in the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Participation in virtual rounds	Study participants will be present during daily ICU team rounds by secure video conference.

Primary Outcome Measures

Name	Time	Method
Recruitment rate of 3 participants per month per site completing initial FAME questionnaire	6 months	Recruitment rate
% of participants completing at least one virtual rounding session	Within 1-week of ICU discharge	Uptake
% of virtual rounds without technical issues	Within 1-week of ICU discharge	Technical issues
% of participants completing follow-up	Within 1-week of ICU discharge	Follow-up of participants

Secondary Outcome Measures

Name	Time	Method
Family satisfaction as measured by FS-ICU 24R	Within 1-week of ICU discharge	Family satisfaction
Anxiety and depression as measured by HADS	Within 1-week of ICU discharge	Anxiety and depression
Family care engagement as measured by FAME	Within 1-week of ICU discharge	Family care engagement

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada