Clinical trial NCT05891860: Virtual Family Participation in ICU Rounds: a Pilot Study
Official title: Virtual Family Participation in ICU Rounds (The VR-Family Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Engagement
Virtual
Critical Care
Keywords: family engagement
virtual
critical care
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
name: McGill Faculty of Medicine
First posted: 2023-06-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate of 3 participants per month per site completing initial FAME questionnaire
timeFrame: 6 months
measure: % of participants completing at least one virtual rounding session
timeFrame: Within 1-week of ICU discharge
measure: % of virtual rounds without technical issues
timeFrame: Within 1-week of ICU discharge
measure: % of participants completing follow-up
timeFrame: Within 1-week of ICU discharge
Secondary outcomes:
measure: Family satisfaction as measured by FS-ICU 24R
timeFrame: Within 1-week of ICU discharge
measure: Anxiety and depression as measured by HADS
timeFrame: Within 1-week of ICU discharge
measure: Family care engagement as measured by FAME
timeFrame: Within 1-week of ICU discharge
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.