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Life sciences · Interventional Study
ClinicalTrials.gov · October 29, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06974214). This is a study registration, not published results. Lead sponsor: Herlev Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ACTUAL). Conditions: Delirium, Anxiety, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family, Depression, Posttraumatic Stress Disorder (PTSD), Mortality, Length of ICU Stay, Pain, Satisfaction Survey. Interventions: OTHER: FAM-ICU. Primary outcome measures: Feasibility, recruitment rate , during ICU admission.; Feasibility, Retention rate , 1 month post ICU admission; Feasibility, Fidelity , during ICU admission.; Acceptability, Adherence , during ICU admission.; Acceptability, Appropriateness , during ICU admission.; Acceptability, Convenience , during ICU admission.; Acceptability, effectiveness , during ICU admission.. Brief summary: 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.