Virtual Family Participation in ICU Rounds: A Pilot Study

Critical Care Clinical Trial

— VR-Family  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891860
• Other study ID #: 2023-3581
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Lady Davis Institute
• Contact: Chella Price, BSc
• Phone: 514-340-8222
• Email: chella.price.ccomtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Family Engagement

Intervention

Other:
• Participation in virtual rounds
Virtual participation in daily ICU team rounds

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Lady Davis Institute	Canadian Institutes of Health Research (CIHR), Unité de Soutien SSA Québec

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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-N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate of 3 participants per month per site completing initial FAME questionnaire	Recruitment rate	6 months
Primary	% of participants completing at least one virtual rounding session	Uptake	Within 1-week of ICU discharge
Primary	% of virtual rounds without technical issues	Technical issues	Within 1-week of ICU discharge
Primary	% of participants completing follow-up	Follow-up of participants	Within 1-week of ICU discharge
Secondary	Family satisfaction as measured by FS-ICU 24R	Family satisfaction	Within 1-week of ICU discharge
Secondary	Anxiety and depression as measured by HADS	Anxiety and depression	Within 1-week of ICU discharge
Secondary	Family care engagement as measured by FAME	Family care engagement	Within 1-week of ICU discharge