Virtual Family Participation in ICU Rounds: a Pilot Study (VR-Family)

Virtual Family Participation in ICU Rounds (The VR-Family Study)

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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Family Engagement; Virtual
• Intervention / Treatment: Other: Participation in virtual rounds

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Study participants will be present during daily ICU team rounds by secure video conference.	Other: Participation in virtual rounds; Virtual participation in daily ICU team rounds

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family satisfaction as measured by FS-ICU 24R	Family satisfaction	Within 1-week of ICU discharge
Anxiety and depression as measured by HADS	Anxiety and depression	Within 1-week of ICU discharge
Family care engagement as measured by FAME	Family care engagement	Within 1-week of ICU discharge

Collaborators and Investigators

• Sponsor: Lady Davis Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Fonds de la Recherche en Santé du Québec; McGill Faculty of Medicine

Publications and helpful links

General Publications

• Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
• Calderone A, Debay V, Goldfarb MJ. Family Presence on Rounds in Adult Critical Care: A Scoping Review. Crit Care Explor. 2022 Nov 7;4(11):e0787. doi: 10.1097/CCE.0000000000000787. eCollection 2022 Nov.
• Au SS, Roze des Ordons AL, Blades KG, Stelfox HT. Best practices toolkit for family participation in ICU rounds. J Eval Clin Pract. 2021 Oct;27(5):1066-1075. doi: 10.1111/jep.13517. Epub 2020 Nov 23.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: critical care; virtual; family engagement
• Other Study ID Numbers: 2023-3581

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
• product manufactured in and exported from the U.S.: No