Virtual Family Participation for ICU Care

(VR-Family Trial)

Overseen By Chella Price, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: In-person rounds, Other family member

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

84 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who are family members of ICU patients expected to stay in the ICU for more than 48 hours. Participants must have the tech skills and equipment (phone or computer with internet, audio/video) to join virtual ICU rounds and communicate in English or French.

Inclusion Criteria

'Family member' is anyone with a biological, legal, or emotional relationship with the patient.

Family member of ICU patient with expected ICU stay > 48 hours (as per treating team)

Willing and able to participate in virtual ICU rounds

Exclusion Criteria

I plan to attend in-person sessions if they are available.

Another family member already participating in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Study participants will be present during daily ICU team rounds by secure video conference

6 months

Follow-up

Participants are monitored for family satisfaction, anxiety, depression, and engagement within 1-week of ICU discharge

1 week

Treatment Details

Interventions

• Participation in virtual rounds

Trial Overview The study is testing if families can join ICU rounds virtually. It looks at how this affects their involvement, satisfaction, and mental health. The trial will also gather feedback from families and doctors on this experience.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Study participants will be present during daily ICU team rounds by secure video conference.

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Quebec Strategy for Patient-Oriented Research (SPOR) SUPPORT Unit

Collaborator

Trials

1

Recruited

80+

Fonds de la Recherche en Santé du Québec

Collaborator

Trials

84

Recruited

46,700+

McGill Faculty of Medicine

Collaborator

Trials

2

Recruited

130+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Unité de Soutien SSA Québec

Collaborator

Trials

1

Recruited

80+