Recruitment and Retention Strategies for Randomized Clinical Trials Involving Family Members of ICU Patients

Abstract

OBJECTIVES: To review recruitment and retention strategies of randomized family-centered interventional studies in adult ICUs. DATA SOURCES: The MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library database from inception to February 2023. STUDY SELECTION: Randomized controlled trials with family-centered interventions in the ICU setting that reported at least one family-centered outcome that were included in our previously published systematic review. DATA EXTRACTION: For recruitment: Number of family members approached and enrolled, type of approach, location, time of day approached, whether medical team approached first, compensation offered, and type of consent. For retention: Number of family members enrolled and completed initial follow-up visit, mode of follow-up, location of follow-up visit, data collection method, timing of follow-up visits, number of follow-up visits, and compensation offered. Recruitment (participants approached/enrolled) and retention (participants enrolled/completed initial follow-up) percentage were calculated. DATA SYNTHESIS: There were 51 studies in the analysis. The mean recruitment percentage was 49.3% ± 24.3%. There were no differences in recruitment percentage by study country, ICU type, recruitment approach, or whether the medical team approached the family member first (all p > 0.05). The mean retention percentage for the initial follow-up visit was 81.6% ± 18.0%. There were no differences in retention percentage by mode of participant contact, data collection type, or follow-up location (all p > 0.05). Minimal data were available to determine the impact of time of day approached and compensation on recruitment and retention outcomes. CONCLUSIONS: About half of family members of ICU patients approached participated in trials and more than eight in ten completed the initial follow-up visit. We did not identify specific factors that impacted family recruitment or retention. There is a strong need for further studies to characterize optimal strategies to ensure family participation in clinical trials.