Critical Care Clinical Trial
— VR-FamilyOfficial title:
Virtual Family Participation in ICU Rounds (The VR-Family Study)
NCT number | NCT05891860 |
Other study ID # | 2023-3581 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 12, 2023 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Lady Davis Institute | Canadian Institutes of Health Research (CIHR), Unité de Soutien SSA Québec |
Canada,
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. — View Citation
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. — View Citation
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-N — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate of 3 participants per month per site completing initial FAME questionnaire | Recruitment rate | 6 months | |
Primary | % of participants completing at least one virtual rounding session | Uptake | Within 1-week of ICU discharge | |
Primary | % of virtual rounds without technical issues | Technical issues | Within 1-week of ICU discharge | |
Primary | % of participants completing follow-up | Follow-up of participants | Within 1-week of ICU discharge | |
Secondary | Family satisfaction as measured by FS-ICU 24R | Family satisfaction | Within 1-week of ICU discharge | |
Secondary | Anxiety and depression as measured by HADS | Anxiety and depression | Within 1-week of ICU discharge | |
Secondary | Family care engagement as measured by FAME | Family care engagement | Within 1-week of ICU discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05114551 -
ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
|
||
Completed |
NCT05547646 -
The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
|
||
Recruiting |
NCT03697785 -
Weaning Algorithm for Mechanical VEntilation
|
N/A | |
Completed |
NCT02922101 -
Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care
|
N/A | |
Completed |
NCT02902783 -
DONATE-Pilot Study on ICU Management of Deceased Organ Donors
|
||
Completed |
NCT01857986 -
Evaluating Air Leak Detection in Intubated Patients
|
N/A | |
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Recruiting |
NCT05518955 -
VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU
|
N/A | |
Recruiting |
NCT03810768 -
Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
|
||
Completed |
NCT03295630 -
Validity of an Actigraph Accelerometer Following Critical Illness
|
N/A | |
Completed |
NCT05556811 -
HEaling LIght Algorithms for the ICU Patient
|
N/A | |
Recruiting |
NCT05702411 -
Air Stacking Technique For Pulmonary Reexpansion
|
N/A | |
Completed |
NCT02741453 -
Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement
|
N/A | |
Recruiting |
NCT04979897 -
Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
|
||
Completed |
NCT05281224 -
Ventilator Tube Holder for Patients With a Tracheostomy
|
||
Withdrawn |
NCT02970903 -
VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU
|
N/A | |
Recruiting |
NCT02587273 -
The Pharmacokinetics of Fentanyl in Intensive Care Patients
|
Phase 4 | |
Completed |
NCT02661607 -
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
|
N/A | |
Completed |
NCT01479153 -
Venous Site for Central Catheterization
|
N/A | |
Recruiting |
NCT06110390 -
High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients
|
N/A |