To examine the effects of a family support intervention in a cluster-randomized controlled trial and address the limitations of no effect trials.
Approach:
Study Design: A cluster-randomized controlled trial involving 885 family members from 16 Swiss adult ICUs, assessing various psychological and quality of life outcomes.
Intervention: A multicomponent family care pathway involving trained ICU family nurses providing psychoeducational and relationship-focused care.
Key Findings:
No differences were observed between intervention and usual care groups in terms of family functioning, resilience, life satisfaction, and mental health outcomes.
The study's findings are consistent with previous trials showing no improvements in long-term mental health outcomes from similar interventions.
Limited information on intervention delivery and uptake raises questions about the added value of the study intervention.
Interpretation:
The study highlights the challenges of delivering effective family support in ICU settings and the complexities of cluster randomization.
Limitations:
Limited number of clusters randomized may lead to imbalance in center-level characteristics and patient case-mix.
Insufficient involvement of multidisciplinary teams may have constrained family support.
The intervention was primarily delivered during the ICU stay, potentially limiting its effectiveness.
Conclusion:
The reasons for the lack of measurable benefits in this study remain unclear.
