NCT06588101

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

Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit: A Study Within A Trial Randomized Design

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Lady Davis Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Family Members
• Recruitment
• Clinical Study
• Retention
• Recruitment of Participants
• Study Enrollment
• Retention of Participants
• Compensation Incentives

Interventions

Type	Name	Description
OTHER	Written 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.
OTHER	Compensation	Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2024-09-19
• Last updated: 2025-06-04

Locations

1 site across 1 country: Canada