Virtual Family Participation in ICU Rounds: A Pilot Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Family Engagement, Virtual, Critical Care

Intervention / Treatment
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* Other: Participation in virtual rounds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family engagement, virtual, critical care