Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU (SWAT)
Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit: A Study Within A Trial Randomized Design
Study Overview
Status
Conditions
Intervention / Treatment
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: Investigators will use a Study Within a Trial (SWAT) design to embed a factorial randomized trial of 160 participants enrolled across investigator group's three ongoing studies involving family members of ICU patients: FAME, VR-Family, and NGAGE. Investigators expect 160 participants to be enrolled over a 6-month period. Participants will be randomized by 2x2 factorial design to selected recruitment and/or retention strategies. The co-primary outcomes will be (1) recruitment rate and (2) retention rate.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jillian Kifell, MSc
- Phone Number: 25806 5143408222
- Email: jillian.kifell.ccomtl@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada
- Recruiting
- Jewish General Hospital
-
Contact:
- Jillian Kifell, MSc
- Phone Number: 25806 5143408222
- Email: jillian.kifell.ccomtl@ssss.gouv.qc.ca
-
Principal Investigator:
- Michael J Goldfarb, MD, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Has family member admitted to an intensive care unit.
- Expected hospital stay > 48 hours
- Able to participate in English or French
Exclusion Criteria:
- Has another family member participating in the trial
- Repeat admissions within the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Both recruitment strategies
Consent form with Infographic + Large compensation
|
Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.
Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.
|
|
No Intervention: Neither recruitment strategy
Consent form + No compensation
|
|
|
Experimental: One recruitment strategy - Infographic
Consent form with Infographic + No compensation
|
Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.
|
|
Experimental: One recruitment strategy - Compensation
Consent form + Large compensation
|
Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment percentage
Time Frame: At enrolment
|
Family member participants enrolled/ family member participants approached
|
At enrolment
|
|
Retention percentage
Time Frame: From enrolment until 6 month follow-up completion
|
Family member participant completing follow-up/family member participants enrolled
|
From enrolment until 6 month follow-up completion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael J Goldfarb, MD, MSc, Lady Davis Institute, McGill University, Jewish General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-4023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.