| NCT ID | NCT06586541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lady Davis Institute |
| Condition | Virtual Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 194 participants in total. It began in 2024-11-18 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.
Eligibility Criteria
Inclusion Criteria: * Adult family members (age ≥ 18 years) of ICU patients * Expected ICU stay ≥ 48 hours * Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio/video capabilities) Exclusion Criteria: * Family members who do not wish to participate in care * Repeat admissions within the study period * Another family member has already participated in the study
Contact & Investigator
Michael J Goldfarb, MD, MSc
PRINCIPAL INVESTIGATOR
Lady Davis Institute, McGill University, Jewish General Hospital
Frequently Asked Questions
Who can join the NCT06586541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Virtual Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06586541 currently recruiting?
Yes, NCT06586541 is actively recruiting participants. Contact the research team at jillian.kifell.ccomtl@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06586541 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06586541 clinical trial?
NCT06586541 is sponsored by Lady Davis Institute. The principal investigator is Michael J Goldfarb, MD, MSc at Lady Davis Institute, McGill University, Jewish General Hospital. The trial plans to enroll 194 participants.