Evidence map›Paper›PMID 39198900›Full record

ArticleTrials2024

Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial.

Stefanie von Felten, Miodrag Filipovic, Marie-Madlen Jeitziner, Lotte Verweij, Marco Riguzzi, Rahel Naef

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05280691 (A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05280691 nacompletednot on this map

A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units

TypeinterventionalSponsorRahel NaefRan2022 to 2025Enrolled885ConditionsPostintensive Care Syndrome, Family Members, Quality of Life, Depression, AnxietyArmsFamily Support Intervention (FSI)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Stefanie von FeltenDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, CH-8001, Switzerland. stefanie.vonfelten@uzh.ch.ORCID http://orcid.org/0000-0002-5264-6394
Miodrag FilipovicDivision of Perioperative Intensive Care Medicine, Kantonsspital St. Gallen, Rorschacher Strasse 95, St. Gallen, CH-9007, Switzerland.
Marie-Madlen JeitzinerDepartment of Intensive Care Medicine, Inselspital, University Hospital Bern, Freiburgstrasse 10, Bern, CH-3010, Switzerland.
Lotte VerweijInstitute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätstrasse 84, Zurich, CH-8006, Switzerland.
Marco Riguzzi *Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätstrasse 84, Zurich, CH-8006, Switzerland.
Rahel Naef *Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätstrasse 84, Zurich, CH-8006, Switzerland.

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 198778
6 · The paper itself

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.

Indexed as

Intensive Care UnitsCritical CareCritical IllnessData Interpretation, StatisticalEquivalence Trials as TopicFamilyFamily SupportHumansMental HealthMulticenter Studies as TopicProfessional-Family RelationsQuality of Health CareRandomized Controlled Trials as TopicSocial SupportTime FactorsCluster-randomized trialComplex interventionCritical careFamily careStatistical analysis plan

Identifiers

PMID39198900
PMCPMC11350995

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.