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

What this Trial Is About

Researchers are evaluating ways to improve how clinical trials enroll and keep family members of intensive care unit (ICU) patients involved. This study focuses on testing four different strategies—two for recruitment and two for retention—within three ongoing trials involving ICU patient families. The goal is to find better methods to engage families in ICU research, helping to generate stronger evidence to support family engagement practices. The study uses a 2x2 factorial design to randomly assign 160 participants into groups receiving different combinations of recruitment and retention strategies. These include providing a written consent form with a visual infographic to explain key information and offering compensation through e-gift cards for completing enrollment questionnaires. Participants will be enrolled over about six months in three existing ICU family member studies: FAME, VR-Family, and NGAGE. Participants will be monitored for the percentage recruited from those approached and the percentage retained through six months of follow-up after enrollment. Researchers will collect data on enrollment and retention rates to assess which strategies work best. The study involves consenting family members who can communicate in English or French and have a relative expected to stay in the ICU for more than 48 hours. Safety and adherence will be tracked, and the study will conclude by the end of 2026.

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