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Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial.
- Source :
-
Trials [Trials] 2024 Aug 28; Vol. 25 (1), pp. 568. Date of Electronic Publication: 2024 Aug 28. - Publication Year :
- 2024
-
Abstract
- The FICUS trial is a cluster-randomized superiority trial to determine the effectiveness of a nurse-led, interprofessional family support intervention (FSI) on the quality of care, family management and individual mental health of family members of critically ill patients, compared to usual care. This paper describes the statistical analysis plan of the FICUS trial. The primary outcome is quality of family care, assessed by the Family Satisfaction in ICU Questionnaire (FS-ICU-24R) at patient discharge from the ICU. Several secondary outcomes are additionally assessed 3, 6, and 12 months thereafter. Sixteen clusters (ICUs) were randomly assigned 1:1 to FSI or usual care using minimization (8 per treatment). The target sample size is 56 patients per cluster (896 in total). Recruitment has been completed in January 2024. The follow-up of the last participant will be completed in early 2025. The primary and secondary outcomes will be analyzed by linear mixed-effects models (LMM). The main model for the primary outcome will include a random intercept per cluster with treatment (FSI vs. usual care) as the only explanatory variable due to the relatively small number of clusters. In addition, covariate-adjusted analyses will be conducted, including two cluster-level characteristics used in the minimization as well as participant-level characteristics. Moreover, a number of subgroup analyses by cluster- and participant-level characteristics are pre-specified.Trial registration ClinicalTrials.gov NCT05280691 . Registered on February 20, 2022.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Family
Mental Health
Data Interpretation, Statistical
Multicenter Studies as Topic
Critical Illness
Time Factors
Randomized Controlled Trials as Topic
Critical Care methods
Quality of Health Care
Social Support
Equivalence Trials as Topic
Professional-Family Relations
Family Support
Intensive Care Units
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 25
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 39198900
- Full Text :
- https://doi.org/10.1186/s13063-024-08351-y