RESUMEN
PURPOSE: Relatives of intensive care unit (ICU) patients suffer emotional distress that impairs their ability to acquire the information they need from the staff. We sought to evaluate whether providing relatives with a list of important questions was associated with better comprehension on day 5. METHODS: Randomized, parallel-group trial. Relatives of mechanically ventilated patients were included from 14 hospitals belonging to the FAMIREA study group in France. A validated list of 21 questions was handed to the relatives immediately after randomization. The primary endpoint was comprehension on day 5. Secondary endpoints were satisfaction (Critical Care Family Needs Inventory, CCFNI) and symptoms of anxiety and depression (Hospital Anxiety and Depression Scale, HADS). RESULTS: Of 394 randomized relatives, 302 underwent the day-5 assessment of all outcomes. Day-5 family comprehension was adequate in 68 (44.2%) and 75 (50.7%) intervention and control group relatives (P = 0.30), respectively. Over the first five ICU days, median number of family-staff meetings/patient was 6 [3-9], median total meeting time was 72.5 [35-110] min, and relatives asked a median of 20 [8-33] questions including 11 [6-13] from the list, with no between-group difference. Satisfaction and anxiety/depression symptoms were not significantly different between groups. The only variable significantly associated with better day-5 comprehension by multivariable analysis was a higher total number of questions asked before day 5. CONCLUSIONS: Providing relatives with a list of questions did not improve day-5 comprehension, secondary endpoints, or information time. Further research is needed to help families obtain the information they need. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02410538.