A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial).

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.

Lessons From the First Wave of COVID-19: Work-Related Consequences, Clinical Knowledge, Emotional Distress, and Safety-Conscious Behavior in Healthcare Workers in Switzerland.

The coronavirus disease (COVID-19) imposes an unusual risk to the physical and mental health of healthcare workers and thereby to the functioning of healthcare systems during the crisis. This study investigates the clinical knowledge of healthcare workers about COVID-19, their ways of acquiring information, their emotional distress and risk perception, their adherence to preventive guidelines, their changed work situation due to the pandemic, and their perception of how the healthcare system has coped with the pandemic. It is based on a quantitative cross-sectional survey of 185 Swiss healthcare workers directly attending to patients during the pandemic, with 22% (n = 40) of them being assigned to COVID-19-infected patients. The participants answered between 16th June and 15th July 2020, shortly after the first wave of COVID-19 had been overcome and the national government had relaxed its preventive regulations to a great extent. The questionnaire incorporated parts of the "Standard questionnaire on risk perception of an infectious disease outbreak" (version 2015), which were adapted to the case of COVID-19. Clinical knowledge was lowest regarding the effectiveness of standard hygiene (p < 0.05). Knowledge of infectiousness, incubation time, and life-threatening disease progression was higher, however still significantly lower than regarding asymptomatic cases and transmission without physical contact (p < 0.001). 70% (95%-confidence interval: 64-77%) of the healthcare workers reported considerable emotional distress on at least one of the measured dimensions. They worried significantly more strongly about patients, elderly people, and family members, than about their own health (p < 0.001). Adherence to (not legally binding) preventive guidelines by the government displayed patterns such that not all guidelines were followed equally. Most of the participants were faced with a lack of protective materials, personnel, structures, processes, and contingency plans. An increase in stress level was the most prevalent among the diverse effects the pandemic had on their work situation. Better medical equipment (including drugs), better protection for their own mental and physical health, more (assigned) personnel, more comprehensive information about the symptoms of the disease, and a system of earlier warning were the primary lessons to be learned in view of upcoming waves of the pandemic.