An interventional study of Written informed consent with infographic and Compensation in Family Members, Recruitment and Clinical Study, sponsored by Lady Davis Institute. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Lady Davis Institute · Not applicable, Interventional, and Other
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. Investigators 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 enrolled/participants approached) and retention percentage (participants completing follow-up/participants enrolled).
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.
Lady Davis Institute is the lead sponsor of 46 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Consent form with Infographic + Large compensation
Other: Written informed consent with infographic · Other: Compensation
Consent form + No compensation
Consent form with Infographic + No compensation
Other: Written informed consent with infographic
Consent form + Large compensation
Other: 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.
Recruitment percentage
Family member participants enrolled/ family member participants approached
Time frame: At enrolment
Retention percentage
Family member participant completing follow-up/family member participants enrolled
Time frame: From enrolment until 6 month follow-up completion
Plan to share: No
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