Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586541
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
The Family-ICU Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Family Participation in Intensive Care Unit Rounds The Family-ICU Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Family-ICU
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 n194 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None