EFFAMPART
Trial question
What is the effect of application of a standardized family participation program in the ICU?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
63.3% female
36.7% male
N = 306
306 patients (191 female, 111 male)
Inclusion criteria: relatives of adult ICU patients
Key exclusion criteria: patients receipt of palliative care; objection to study participation; unwillingness to complete the questionnaires
Interventions
N=73 standardized family participation program (standardized program to facilitate family participation in essential care activities in the ICU)
N=233 control (no structural facilitation of family participation)
Primary outcome
Anxiety in relatives
5
6
6.0
4.5
3.0
1.5
0.0
Standardized family participation
program
Control
No significant
difference ↔
No significant difference in anxiety in relatives (5 vs. 6 ; MR 0.72, 95% CI 0.46 to 1.13)
Secondary outcomes
No significant difference in depression in relatives (4 vs. 3 ; MR 0.85, 95% CI 0.55 to 1.32)
No significant difference in posttraumatic stress score in relatives (0.45 points vs. 0.41 points; MR 0.94, 95% CI 0.78 to 1.14)
Significant decrease in mean reported satisfaction in relatives (8.9 vs. 9.06 ; AD -0.6 , 95% CI -1.07 to -0.12)
Conclusion
In relatives of adult ICU patients, standardized family participation program was not superior to control with respect to anxiety in relatives.
Reference
Boukje M Dijkstra, Paul J T Rood, Steven Teerenstra et al. Effect of a Standardized Family Participation Program in the ICU: A Multicenter Stepped-Wedge Cluster Randomized Controlled Trial. Crit Care Med. 2024 Mar 1;52(3):420-431.
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