Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLady Davis Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has family member admitted to an intensive care unit.

Expected hospital stay > 48 hours

Able to participate in English or French

Disqualifiers

Has another family member participating in the trial

Repeat admissions within the study period

Trial design

Design model

Factorial

Treatments tested in this trial

  • Written informed consent with infographic

    Other intervention

    Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.

  • Compensation

    Other intervention

    Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Both recruitment strategiesExperimental treatment 2 interventions
Group B: Neither recruitment strategyNo intervention 0 interventions
Group C: One recruitment strategy - InfographicExperimental treatment 1 intervention
Group D: One recruitment strategy - CompensationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment percentage

Family member participants enrolled/ family member participants approached

Time frame
At enrolment
2

Retention percentage

Family member participant completing follow-up/family member participants enrolled

Time frame
From enrolment until 6 month follow-up completion

Secondary outcomes

Other outcomes

Sponsors and contacts

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Lady Davis Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator