Family EngagementVR-FamilyNCT05891860
Virtual Family Participation in ICU Rounds: A Pilot Study
A study testing Participation in virtual rounds in people with Family Engagement and Virtual, run by Lady Davis Institute at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Engagement, Virtual, Critical Care
- What is being tested?
- Participation in virtual rounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Intends to participate in in-person rounds (if available and offered at participating site)
- Another family member already participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Family Participation in ICU Rounds (The VR-Family 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.
- Conditions
- Family Engagement, Virtual, Critical Care
- Being tested
- Participation in virtual rounds
- Keywords
- family engagement, virtual, critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in virtual roundsOther
Virtual participation in daily ICU team rounds
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Study participants will be present during daily ICU team rounds by secure video conference. Receives: Other: Participation in virtual rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate of 3 participants per month per site completing initial FAME questionnaire
Recruitment rate
Measured: 6 months
% of participants completing at least one virtual rounding session
Uptake
Measured: Within 1-week of ICU discharge
% of virtual rounds without technical issues
Technical issues
Measured: Within 1-week of ICU discharge
% of participants completing follow-up
Follow-up of participants
Measured: Within 1-week of ICU discharge
Secondary outcomes (3)
Family satisfaction as measured by FS-ICU 24R
Family satisfaction
Measured: Within 1-week of ICU discharge
Anxiety and depression as measured by HADS
Anxiety and depression
Measured: Within 1-week of ICU discharge
Family care engagement as measured by FAME
Family care engagement
Measured: Within 1-week of ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start12 Jun 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Family EngagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, McGill University
- Responsible party
- Principal investigator, Michael Goldfarb, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891860
- Sponsor's protocol ID
- 2023-3581
- Acronym
- VR-Family
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36382337Au 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.
PubMed 33230927Davidson 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.
PubMed 27984278Beydoun SA, Bahrami S, Burns KEA, Debigare S, Duong J, Gagne C, Kifell J, Price C, Rubulotta F, Stephenson A, Udupa S, Wang HT, Goldfarb M. Virtual family participation in adult intensive care unit rounds: A multicenter pilot feasibility cohort study. J Crit Care. 2026 Feb;91:155245. doi: 10.1016/j.jcrc.2025.155245. Epub 2025 Aug 24.
PubMed 40849979
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Family Participation in ICU Rounds (The VR-Family Study)
- ClinicalTrials.gov ID
- NCT05891860
- Acronym / sponsor ID
- VR-Family / 2023-3581
- Conditions
- Family Engagement, Virtual, Critical Care
- Keywords
- family engagement, virtual, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, McGill University
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Participation in virtual roundsStudy participants will be present during daily ICU team rounds by secure video conference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- Intends to participate in in-person rounds (if available and offered at participating site)
- Another family member already participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in virtual roundsVirtual participation in daily ICU team rounds | Other | Intervention |
Primary outcome
Recruitment rate of 3 participants per month per site completing initial FAME questionnaire
Time frame: 6 months
Recruitment rate
% of participants completing at least one virtual rounding session
Time frame: Within 1-week of ICU discharge
Uptake
% of virtual rounds without technical issues
Time frame: Within 1-week of ICU discharge
Technical issues
% of participants completing follow-up
Time frame: Within 1-week of ICU discharge
Follow-up of participants
3 secondary outcomes
Family satisfaction as measured by FS-ICU 24R
Time frame: Within 1-week of ICU discharge
Anxiety and depression as measured by HADS
Time frame: Within 1-week of ICU discharge
Family care engagement as measured by FAME
Time frame: Within 1-week of ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Results publication: PubMed 36382337Calderone 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.
- Results publication: PubMed 33230927Au 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.
- Results publication: PubMed 27984278Davidson 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.
- Derived from this study: PubMed 40849979Beydoun SA, Bahrami S, Burns KEA, Debigare S, Duong J, Gagne C, Kifell J, Price C, Rubulotta F, Stephenson A, Udupa S, Wang HT, Goldfarb M. Virtual family participation in adult intensive care unit rounds: A multicenter pilot feasibility cohort study. J Crit Care. 2026 Feb;91:155245. doi: 10.1016/j.jcrc.2025.155245. Epub 2025 Aug 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in virtual rounds in people with Family Engagement and Virtual, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate of 3 participants per month per site completing initial FAME questionnaire (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891860, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.