Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586528
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Increasing Family Engagement in Critical Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Increasing Family Engagement in Critical Care the NGAGE Trial The NGAGE 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:
NGAGE
Brief Summary:
The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients The secondary objectives are to assess if the NGAGE tool improves communication care satisfaction psychological symptoms and quality of life in family members of ICU patients
The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs involving 194 family members A family member will be considered anyone with a biological emotional or legal relationship with the patient and whom the patient wishes to be involved in their care There will be random and sequential crossover of clusters from control phase 1 to intervention phase 2 until all clusters are exposed The intervention group will have access to the NGAGE tool which has modules to Learn Engage and Report Engage allows the family member to indicate their desired engagement activity which is then transmitted to the treating healthcare team to provide the requested activity Learn contains educational capsules about the ICU environment and information about care participation Report allows the family member to provide real-time feedback to the healthcare team The primary endpoint is the FAMily Engagement FAME score within 1 week of ICU discharge Secondary endpoints are family-centered outcomes including communication quality satisfaction and mental health anxiety and depression scores within 1 week of ICU discharge and quality of life and mental health anxiety depression and post-traumatic distress symptoms at 6 months The mean difference of the validated FAME score a continuous variable will be compared between groups
The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs involving 194 family members A family member will be considered anyone with a biological emotional or legal relationship with the patient and whom the patient wishes to be involved in their care There will be random and sequential crossover of clusters from control phase 1 to intervention phase 2 until all clusters are exposed The intervention group will have access to the NGAGE tool which has modules to Learn Engage and Report Engage allows the family member to indicate their desired engagement activity which is then transmitted to the treating healthcare team to provide the requested activity Learn contains educational capsules about the ICU environment and information about care participation Report allows the family member to provide real-time feedback to the healthcare team The primary endpoint is the FAMily Engagement FAME score within 1 week of ICU discharge Secondary endpoints are family-centered outcomes including communication quality satisfaction and mental health anxiety and depression scores within 1 week of ICU discharge and quality of life and mental health anxiety depression and post-traumatic distress symptoms at 6 months The mean difference of the validated FAME score a continuous variable will be compared between groups
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