Title (1) | A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial) |
Trial registration (2a and 2b). | ClinicalTrials.gov, NCT05280691, and the Swiss National Clinical Trials Portal (SNCTP), SNCTP000004842 |
Protocol version (3) | Version 1.0, 25. October 2021 |
Funding (4) | The study is funded by the Swiss National Science Fund (SNSF, grant no. 33IC30_198778/1). |
Author details (5a) |
Rahel Naef: Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich and Center of Clinical Nursing Science, University Hospital Zurich, Universitätsstrasse 84, CH-8006 Zurich, Switzerland. Miodrag Filipovic: Surgical Intensive Care Unit, Rescue and Pain Medicine, Intensive Care, Division of Anesthesiology, Cantonal Hospital of St. Gallen, Rorschacher Strasse 95, CH-9007 St. Gallen, Switzerland. Marie-Madlen Jeitziner: Department of Intensive Care Medicine, University Hospital Bern, Inselspital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland. Stefanie von Felten: Department of Biostatistics, Epidemiology, Biostatistics, and Prevention Institute, Faculty of Medicine, University of Zurich, Hirschengraben 84, 8001 Zurich, Switzerland. Judith Safford: Patient representative, no affiliation Marco Riguzzi: Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich and Center of Clinical Nursing Science, University Hospital Zurich, Universitätsstrasse 84, 8006 Zurich, Switzerland. Michael Rufer: Department of Psychiatry, Psychotherapy, and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich and Center for Psychiatry and Psychotherapy, Psychiatric Hospital Zugersee, Triaplus AG, Widenstrasse 55, 6317 Oberwil-Zug, Switzerland. |
Name and contact information of the trial sponsor (5b) |
Rahel Naef, PhD, RN Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich and Center of Clinical Nursing Science, University Hospital Zurich, Universitätsstrasse 84, CH-8006 Zurich, Switzerland. E-Mail: rahel.naef@uzh.ch Phone: +41 44 634 37 49 |
Role of sponsor (5c) |
The sponsor-investigator acts as the coordinating investigator of the trial and has a primary role regarding study design; collection, management, analysis, and interpretation of the data; and writing of the report. She has ultimate authority over these activities. The funder (Swiss National Science Fund) has no role in the development of the study design; collection, analysis, or interpretation of the data; writing of the manuscript; or decision to submit the manuscript for publication. |