VR-Family: Virtual Family Participation in ICU Rounds: A Pilot Study

Sponsor
Lady Davis Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05891860
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), Unité de Soutien SSA Québec (Other)
72
1
18

Study Details

Study Description

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 randomized controlled 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Participation in virtual rounds
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Virtual Family Participation in ICU Rounds (The VR-Family Study)
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

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

Outcome Measures

Primary Outcome Measures

  1. Recruitment rate of 3 participants per month per site completing initial FAME questionnaire [6 months]

    Recruitment rate

  2. % of participants completing at least one virtual rounding session [Within 1-week of ICU discharge]

    Uptake

  3. % of virtual rounds without technical issues [Within 1-week of ICU discharge]

    Technical issues

  4. % of participants completing follow-up [Within 1-week of ICU discharge]

    Follow-up of participants

Secondary Outcome Measures

  1. Family satisfaction as measured by FS-ICU 24R [Within 1-week of ICU discharge]

    Family satisfaction

  2. Anxiety and depression as measured by HADS [Within 1-week of ICU discharge]

    Anxiety and depression

  3. Family care engagement as measured by FAME [Within 1-week of ICU discharge]

    Family care engagement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lady Davis Institute
  • Canadian Institutes of Health Research (CIHR)
  • Unité de Soutien SSA Québec

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lady Davis Institute
ClinicalTrials.gov Identifier:
NCT05891860
Other Study ID Numbers:
  • 2023-3581
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lady Davis Institute

Study Results

No Results Posted as of Jun 7, 2023