Abstract
Purpose
Suboptimal communication with clinicians, fragmented care and failure to align with patients' preferences are determinants of post intensive care unit (ICU) burden in family members. Our aim was to evaluate the impact of a nurse facilitator on family psychological burden.
Methods
We carried out a randomised controlled trial in five ICUs in France comparing standard communication by ICU clinicians to additional communication and support by nurse facilitators. We included patients > 18 years, with expected ICU length of stay > 2 days, chronic life-limiting illness, and their family members. Facilitators were trained to help families to secure care in line with patient's goals, beginning in ICU and continuing for 3 months. Assessments were made at baseline and 1, 3 and 6 months post-randomisation. Primary outcome was the evolution of family symptoms of depression over 6 months using a linear mixed effects model on the depression subscale of the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes included HADS-Anxiety, Impact of Event Scale-6, goal-concordant care and experience of serious illness (QUAL-E).
Results
385 patients and family members were enrolled. Follow-up at 1-, 3- and 6-month was completed by 284 (74%), 264 (68.6%) and 260 (67.5%) family members respectively. The intervention was associated with significantly more formal meetings between the ICU team and the family (1 [1–3] vs 2 [1–4]; p < 0.001). There was no significant difference between the intervention and control groups in evolution of symptoms of depression over 6 months (p = 0.91), nor in symptoms of depression at 6 months [0.53 95% CI (− 0.48; 1.55)]. There were no significant differences in secondary outcomes.
Conclusion
This study does not support the use of facilitators for family members of ICU patients.
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Data availability
Access to data and data analysis: EA and MR-R had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. MR-R from the Saint-Louis hospital Paris, France, conducted and is responsible for the data analysis. Data sharing: according to the Sponsor rules, the AP-HP is the owner of the data and no use or transmission to a third party can be made without its prior agreement. The steering committee will facilitate the use of the data and approval will not be unreasonably withheld. De-identified participant data will be made available to bona fide researchers registered with an appropriate institution within 3 months of publication. However, the steering committee will need to be satisfied that any proposed publication is of high quality, honours the commitments made to the participants in the consent documentation and ethical approvals, and is compliant with relevant legal and regulatory requirements (e.g. relating to data protection and privacy). The steering committee will have the right to review and comment on any draft manuscripts before publication.
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Funding
All financial support for the research was provided by French Ministry of Health. The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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JRC, NKB, RE and EA wrote the study protocol. LB and MRR designed the study, planned and did the statistical analysis. All co-authors approved the study protocol. NKB wrote the first draft of the report with input from EA, MMR, RE, LB, and FP. JR, AC, AL, OH, TG, AR, VS, PC, FD, LL, SL, and AR provided substantial contribution to the acquisition of data. EA and NKB accessed and verified the data. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.
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NK-B reported grants from French Ministry of Health during the conduct of the study and outside the submitted work. EA reported receipt of personal fees (lectures) from Pfizer, Gilead, Baxter, and Alexion; and institutional research grants from Merck Sharp and Dohme, Pfizer, Baxter, and Alexion outside the submitted work. AC received fees for conferences from Bard, outside the submitted work. All the other Authors have no conflict of interest to declare.
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Supplemental Fig. 1: Distribution of family interaction from randomisation to end of follow-up (x axis). Each dot corresponds to a family interaction. The total number of dots is 2246. (PDF 104 KB)
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Kentish-Barnes, N., Azoulay, E., Reignier, J. et al. A randomised controlled trial of a nurse facilitator to promote communication for family members of critically ill patients. Intensive Care Med (2024). https://doi.org/10.1007/s00134-024-07390-y
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DOI: https://doi.org/10.1007/s00134-024-07390-y