Your browser doesn't support javascript.
A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial).
Naef, Rahel; Filipovic, Miodrag; Jeitziner, Marie-Madlen; von Felten, Stefanie; Safford, Judith; Riguzzi, Marco; Rufer, Michael.
  • Naef R; Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätsstrasse 84, 8006, Zurich, Switzerland. rahel.naef@uzh.ch.
  • Filipovic M; Centre of Clinical Nursing Science, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, Switzerland. rahel.naef@uzh.ch.
  • Jeitziner MM; Surgical Intensive Care Unit, Division of Anesthesiology, Intensive Care, Rescue and Pain Medicine, Cantonal Hospital of St. Gallen, Rorschacher Strasse 95, 9007, St. Gallen, Switzerland.
  • von Felten S; Department of Intensive Care Medicine, University Hospital Bern, Inselspital, University of Bern, Freiburgstrasse 16, CH10, Bern, Switzerland.
  • Safford J; Department of Biostatistics, Epidemiology, Biostatistics, and Prevention Institute, Faculty of Medicine, University of Zurich, Hirschengraben 84, 8001, Zurich, Switzerland.
  • Riguzzi M; , Bern, Switzerland.
  • Rufer M; Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätsstrasse 84, 8006, Zurich, Switzerland.
Trials ; 23(1): 533, 2022 Jun 27.
Article in English | MEDLINE | ID: covidwho-2317535
ABSTRACT

BACKGROUND:

Family members of critically ill patients face considerable uncertainty and distress during their close others' intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.

METHODS:

To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after 3, 6, and 12 months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.

DISCUSSION:

This trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and could be scaled up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being. TRIAL REGISTRATION ClinicalTrials.gov NCT05280691 . Prospectively registered on 20 February 2022.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Critical Illness / Ficus Type of study: Cohort study / Diagnostic study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Topics: Long Covid Limits: Adult / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06454-y

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Critical Illness / Ficus Type of study: Cohort study / Diagnostic study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Topics: Long Covid Limits: Adult / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06454-y