Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FAM-ICU.
- Who it may be relevant to
- Registry conditions: Delirium, Anxiety, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other FAM-ICU
This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice.
Primary outcome measures
- Feasibility, recruitment rate [Time frame: during ICU admission.]
- Feasibility, Retention rate [Time frame: 1 month post ICU admission]
- Feasibility, Fidelity [Time frame: during ICU admission.]
- Acceptability, Adherence [Time frame: during ICU admission.]
- Acceptability, Appropriateness [Time frame: during ICU admission.]
- Acceptability, Convenience [Time frame: during ICU admission.]
- Acceptability, effectiveness [Time frame: during ICU admission.]
Secondary outcome measures (12)
- Free of delirium [Time frame: during ICU admission.]
- Anxiety, patients [Time frame: 1 month post ICU admission]
- Depression, patients [Time frame: 1 month post ICU admission]
- PTSD, patients [Time frame: 1 month post ICU admission]
- Health-related quality of life, patients [Time frame: 1 month post ICU admission]
- Free of life support [Time frame: during ICU admission.]
- Survival [Time frame: 1 month post ICU admission]
- Employment status, patient [Time frame: 1 month post ICU admission]
- Cognitive function [Time frame: 1 month post ICU admission]
- Out of hospital [Time frame: 1 month post ICU admission]
- Anxiety, family [Time frame: 1 month post ICU admission]
- Depression, family [Time frame: 1 post ICU admission]
Eligibility criteria
Patients are eligible if they are:
- ≥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.
Family members are eligible if they are:
- ≥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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Bohart S, Waldau T, Andreasen AS, Moller AM, Thomsen T. Patient- and family-centered care in adult ICU (FAM-ICU): A protocol for a feasibility study. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14539. doi: 10.1111/aas.14539. Epub 2024 Oct 24. PMID 39445615
Identifiers
NCT: NCT06974214 · Herlev Hospital