Background: In the intensive care unit (ICU), delirium in patients and long-term mental health challenges in both patients and their family members are highly prevalent. To address these issues, patient- and family-centered care has been recommended to alleviate the burdens associated with critical illness and ICU admission. We have developed the patient- and FAMily-centered care in the adult ICU intervention (FAM-ICU intervention). This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice. In this protocol, we describe a study aiming to evaluate the feasibility and acceptability of the FAM-ICU intervention in the adult ICU setting, including the feasibility of collecting relevant patient- and family-member outcome data.
Referenc: Bohart et al. 2024. Acta Anaesthesiol Scand
. 2025 Jan;69(1):e14539. doi: 10.1111/aas.14539. Epub 2024 Oct 24. Method: We will conduct a pre-/post two-group study design. We plan to recruit 30 adult ICU patients and their close family members at Herlev University Hospital in Denmark. The pre-group (n = 15) will receive usual care and the post-group (n = 15) will receive the FAM-ICU intervention. The FAM-ICU intervention involves interdisciplinary training of the ICU team and a systematic approach to information sharing and consultations with the patients and their family. Feasibility outcomes will include recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Acceptability will be assessed through questionnaires and interviews with clinicians, patients, and family members. Data collection is scheduled to begin in January 2025.
Discussion: This study will assess the feasibility and acceptability when implementing the FAM-ICU intervention and the feasibility of conducting a main trial to investigate its effectiveness on delirium in patients and the mental health of patients and family members. The data from the feasibility study will be used to guide sample size calculations, trial design, and final data collection methods for a subsequent stepped-wedge randomized controlled trial.
≥18 years of age.
Expected to require ICU admission for at least 48 hours in a mixed surgical and medical ICU for adult critically ill patients.
≥18 years of age.
a close family member to a patient-enrolled in the FAM-ICU. A family-member can be blood-related or not. It may be a spouse, relative, partner, or friend as determined by the patient as a close family member.
None
Sequential
FAM-ICU
Other interventionThis multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice.
Feasibility, recruitment rate
Number of approached participants who consent to participate.
Feasibility, Retention rate
The number of non-responders to the self-reported questionnaires at 6 months.
Feasibility, Fidelity
The frequency and resource use of intervention delivery. Free text describing experienced barriers and facilitators for completing/not completing an intervention component.
Acceptability, Adherence
Willingness to follow the intervention (Including barriers and facilitators).
Free of delirium
Number of delirium free days assessed by Confusion assessment method ICU (CAM-ICU)
Anxiety, patients
Symptoms of anxiety, using Hospital Anxiety and Depression Scale
Depression, patients
Symptoms of depression using Hospital Anxiety and Depression Scale.
PTSD, patients
Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).
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