Clinical Study, Compensation Incentives, Family Members, Recruitment, Recruitment of Participants, Retention, Retention of Participants, Study Enrollment
Conditions
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. 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).
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.
Interventions
OTHERWritten informed consent with infographic
Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.
OTHERCompensation
Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.
Sponsors
Canadian Institutes of Health Research (CIHR)
Lady Davis Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
2x2 Design for randomization strategies 2x2 Desgin for retention strategies
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment percentage | At enrolment | Family member participants enrolled/ family member participants approached |
| Retention percentage | From enrolment until 6 month follow-up completion | Family member participant completing follow-up/family member participants enrolled |
Countries
Canada
Contacts
Primary ContactJillian Kifell, MSc
Outcome results
None listed