Virtual Family Participation in ICU Rounds: a Pilot Study

NCT05891860 | Completed

• 1 other identifier: 2023-3581
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Engagement; Virtual; Critical Care

Keywords

family engagement; virtual; critical care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Family satisfaction as measured by FS-ICU 24R

  Within 1-week of ICU discharge

• Anxiety and depression as measured by HADS

  Within 1-week of ICU discharge

• Family care engagement as measured by FAME

  Within 1-week of ICU discharge

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Participation in virtual rounds

Interventions

Participation in virtual rounds OTHER

Virtual participation in daily ICU team rounds

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intends to participate in in-person rounds (if available and offered at participating site)
• Another family member already participating in the study

Sponsors & Collaborators

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

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (3)

• 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.

  PMID: 36382337 BACKGROUND

• 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.

  PMID: 33230927 BACKGROUND

• 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.

  PMID: 27984278 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: June 7, 2023
• Study Start: June 12, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)