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

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.

Do Interventions Improve Symptoms Among ICU Surrogates Facing End-of-Life Decisions? A Prognostically-Enriched Systematic Review and Meta-Analysis

“…We identified eight ongoing trials targeting ICU surrogates faced with end-of-life healthcare decisions (48–55). Interventions include written rounding summaries (48), electronic decision support aids (49, 55) and interactive web-based support tools (50), a cognitive-behavioral intervention (52), early integration of specialty palliative care (51), and enhanced interprofessional ICU care overseen by nurse specialists (53, 54).…”

Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study)

“…Open access of a nurse-led, interprofessional delivered family support intervention (FSI) in Swiss ICUs. 4 Successful implementation of the three FSI components, namely family engagement, support and communication by a family nurse and interprofessional team along the patient pathway is expected to increase the likelihood of clinical effectiveness, and will be critically influenced by the context into which the intervention is introduced, particularly as part of a multisite clinical trial. [5][6][7][8] Specific implementation guidance for integrating FSIs in critical healthcare settings is still scarce.…”

Methodological progress note: Hybrid effectiveness‐implementation clinical trials

“…A Type 1 hybrid trial focuses primarily on the intervention effectiveness outcomes while exploring the context for future intervention implementation (e.g., Wooldridge et al's 10 evaluation of nonadherence in patients who received discharge medication counseling by a pharmacist as part of an RCT; Naef et al 13 evaluation of a multicomponent family support intervention in intensive care settings).…”

“…Hybrid trials exist on a continuum, with the three designs varying based on their primary focus and the amount of emphasis on effectiveness versus implementation outcomes (see Table 1 and Figure 1) 11 , 12 : A Type 1 hybrid trial focuses primarily on the intervention effectiveness outcomes while exploring the context for future intervention implementation (e.g., Wooldridge et al's 10 evaluation of nonadherence in patients who received discharge medication counseling by a pharmacist as part of an RCT; Naef et al 13 evaluation of a multicomponent family support intervention in intensive care settings). A Type 2 hybrid trial has a dual focus on intervention effectiveness and implementation outcomes (e.g., Gilmartin et al's 14 evaluation of the effectiveness of the rural transitions nurse program; Hassett et al's 15 implementation of patient‐reported outcomes for symptom management in oncology practice). A Type 3 hybrid trial focuses primarily on implementation outcomes while also exploring effectiveness outcomes as they relate to uptake, integration, and fidelity of the intervention in real‐world settings (e.g., Bonafide et al's 16 evaluation of a safety huddle‐based intervention; Salloum et al's 17 evaluation of clinical decision support for patient‐centered chronic pain management).…”