Abstract
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.
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Funding
The study was funded by the French Ministry of Health, which had no role in the study design, conduct, interpretation, reporting, or publication decisions.
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Authors have participated in the design (EA, LP, NKB, MM, EJ), acquisition (JMF, IV, AR, SV, SJ, JDG, CS, HG, SM, AC, SH, LA, ML), analysis (EA, LP, NKB, MM, EJ), and interpretation of the data (EA, LP, NKB, MM, EJ, JRC). All have participated in drafting and revising the paper. All approved the final version and all are accountable for all aspects of the work.
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Dr. Azoulay reports personal fees and other from Gilead, personal fees from Astellas, personal fees from Baxter, personal fees from Alexion, personal fees from Ablynx, outside the submitted work. Other authors declare no conflict of interest.
Ethical standards
The study protocol was approved by the appropriate ethics committee (IFR 48 #13-004, Marseille) and French health authorities (CNIL DR-2013-497; CCTIRS 13.332). The trial was registered on ClinicalTrials.gov (NCT02410538). Informed consent was obtained from all participants.
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Azoulay, E., Forel, JM., Vinatier, I. et al. Questions to improve family–staff communication in the ICU: a randomized controlled trial. Intensive Care Med 44, 1879–1887 (2018). https://doi.org/10.1007/s00134-018-5423-2
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DOI: https://doi.org/10.1007/s00134-018-5423-2