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Completed

NCT Number: NCT05891860

Virtual Family Participation in ICU Rounds: A Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Participation in virtual rounds

Other

Virtual participation in daily ICU team rounds

Primary outcomes

  1. Recruitment rate of 3 participants per month per site completing initial FAME questionnaire

    Time frame: 6 months

    Recruitment rate

  2. % of participants completing at least one virtual rounding session

    Time frame: Within 1-week of ICU discharge

    Uptake

  3. % of virtual rounds without technical issues

    Time frame: Within 1-week of ICU discharge

    Technical issues

  4. % of participants completing follow-up

    Time frame: Within 1-week of ICU discharge

    Follow-up of participants

Secondary outcomes

  1. Family satisfaction as measured by FS-ICU 24R

    Time frame: Within 1-week of ICU discharge

    Family satisfaction

  2. Anxiety and depression as measured by HADS

    Time frame: Within 1-week of ICU discharge

    Anxiety and depression

  3. Family care engagement as measured by FAME

    Time frame: Within 1-week of ICU discharge

    Family care engagement

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
  • McGill Faculty of Medicine

Registry information

Official study title

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

Acronym: VR-Family

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2023
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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