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Trial question
What is the role of a family support intervention delivered by the interprofessional ICU team among critically ill patients and their surrogates?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 1420
1420 patients (695 female, 725 male).
Inclusion criteria: ICU patients with a high risk of death and their surrogates.
Key exclusion criteria: no surrogate decision-maker or receipt of only comfort-focused treatment, surrogates < 18 years of age, or unable to read or understand English.
Interventions
N=547 family support intervention (a multicomponent family support intervention delivered by the interprofessional ICU team with 429 surrogates).
N=873 control (usual care, with 677 surrogates).
Primary outcome
Surrogates' mean score on Hospital Anxiety and Depression Scale at 6 months
11.7 points
12 points
12.0 points
9.0 points
6.0 points
3.0 points
0.0 points
Family support intervention
Control
No significant difference ↔
No significant difference in surrogates' mean score on the Hospital Anxiety and Depression Scale at 6 months (11.7 points vs. 12 points; AD -0.34 points, 95% CI -1.67 to 0.99).
Secondary outcomes
No significant difference in surrogates' mean scores on the Impact of Event Scale (21.2 points vs. 20.3 points; AD 0.9 points, 95% CI -1.66 to 3.47).
Significant increase in surrogates' mean Quality of Communication score (69.1 points vs. 62.7 points; AD 6.39 points, 95% CI 2.57 to 10.2).
Significant decrease in length of ICU stay (6.7 days vs. 7.4 days; IRR 0.9, 95% CI 0.81 to 1).
Safety outcomes
No significant differences in death at 6 months, living independently at home at 6 months.
Significant differences in modified Patient Perception of Patient Centeredness score (1.7 vs. 1.8), death in the hospital (36.0% vs. 28.5%).
Conclusion
In ICU patients with a high risk of death and their surrogates, family support intervention was not superior to control with respect to surrogates' mean score on the Hospital Anxiety and Depression Scale at 6 months.
Reference
Douglas B White, Derek C Angus, Anne-Marie Shields et al. A Randomized Trial of a Family-Support Intervention in Intensive Care Units. N Engl J Med. 2018 Jun 21;378(25):2365-2375.
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