Evaluation of a strategy for enrolling the families of critically ill patients in research using limited human resourcesReport as inadecuate

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Clinical trials of interventions aimed at the families of intensive care unit ICU patients have proliferated but recruitment for these trials can be challenging.


To evaluate a strategy for recruiting families of patients currently being treated in an ICU using limited human resources and time-varying daily screening over 7 consecutive days


We screened the Johns Hopkins Hospital medical ICU census 7 days per week to identify eligible family members. We then made daily, in-person attempts to enroll eligible families during a time-varying 2-hour enrollment period until families declined participation, consented, or were no longer eligible.

Measurements and main results

The primary outcome was the proportion of eligible patients for whom ≥1 family member was enrolled. Secondary outcomes included enrollment of legal healthcare proxies, the consent rate among families approached for enrollment, and success rates for recruiting at different times during the day and week. Among 284 eligible patients, 108 38%, 95% CI 32%-44% had ≥1 family member enrolled, and 75 26%, 95% CI 21%-32% had their legal healthcare proxy enrolled. Among 117 family members asked to participate, 108 92%, 95% CI 86%-96% were enrolled. Patients with versus without an enrolled proxy were more likely to be white 44% vs. 30%, P = .02, live in a zip code with a median income of ≥$100,000 15% vs. 5%, P = .01, be mechanically ventilated 63% vs. 47%, P = .01, die in the ICU 19% vs. 9%, P = .03, and to have longer ICU stays median 5.0 vs. 1.8 days, P<.001. Day of the week and time of day were not associated with family presence in the ICU or consent rate.


Family members were recruited for more than one third of eligible patients, and >90% of approached consented to participate. There are important demographic differences between patients with vs without an enrolled family member.

Author: Alison E. Turnbull , Mohamed D. Hashem, Anahita Rabiee, An To, Caroline M. Chessare, Dale M. Needham

Source: http://plos.srce.hr/


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