Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial.
Humans
Intensive Care Units
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
Cluster-randomized trial
Complex intervention
Critical care
Family care
Statistical analysis plan
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
28 Aug 2024
28 Aug 2024
Historique:
received:
07
02
2024
accepted:
22
07
2024
medline:
31
8
2024
pubmed:
31
8
2024
entrez:
28
8
2024
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 39198900
doi: 10.1186/s13063-024-08351-y
pii: 10.1186/s13063-024-08351-y
doi:
Banques de données
ClinicalTrials.gov
['NCT05280691']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
568Subventions
Organisme : Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
ID : 198778
Informations de copyright
© 2024. The Author(s).
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