Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588101
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-19
Brief Title:
Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit A Study Within A Trial Randomized Design
Status:
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:
SWAT
Brief Summary:
There is a need to identify strategies that improve the conduct of clinical trials involving family members of intensive care unit ICU patients The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients 4 strategies 2 recruitment and 2 retention will be tested We will integrate the strategies into three existing studies that involve family members of ICU patients Participants will be randomized using a 2x2 factorial design The co-primary outcomes are recruitment percentage participants enrolledparticipants approached and retention percentage participants completing follow-upparticipants enrolled
Detailed Description:
Family engagement in the ICU is recommended by critical care professional societies but insufficient evidence of its benefits for patients and family members has hindered clinical uptake Thus high-quality evidence is needed to promote and support family engagement practices A specific unmet need is to identify strategies to improve the recruitment and retention of families in clinical trials in the ICU setting The objective of this study is to evaluate recruitment and retention strategies for clinical trials involving family members in the ICU setting
Methodological Approach We will use a Study Within a Trial SWAT design to embed a factorial randomized trial of 160 participants enrolled across our groups three ongoing studies involving family members of ICU patients FAME VR-Family and NGAGE We expect 160 participants to be enrolled over a 6-month period Participants will be randomized by 2x2 factorial design to selected recruitment andor retention strategies The co-primary outcomes will be 1 recruitment rate and 2 retention rate
Methodological Approach We will use a Study Within a Trial SWAT design to embed a factorial randomized trial of 160 participants enrolled across our groups three ongoing studies involving family members of ICU patients FAME VR-Family and NGAGE We expect 160 participants to be enrolled over a 6-month period Participants will be randomized by 2x2 factorial design to selected recruitment andor retention strategies The co-primary outcomes will be 1 recruitment rate and 2 retention rate
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