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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
This 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.
Time frame: during ICU admission.
Feasibility, Retention rate
The number of non-responders to the self-reported questionnaires at 6 months.
Time frame: 1 month post ICU admission
Feasibility, Fidelity
The frequency and resource use of intervention delivery. Free text describing experienced barriers and facilitators for completing/not completing an intervention component.
Time frame: during ICU admission.
Acceptability, Adherence
Willingness to follow the intervention (Including barriers and facilitators).
Time frame: during ICU admission.
Acceptability, Appropriateness
Perception of how suitable the intervention is for the target population,
Time frame: during ICU admission.
Acceptability, Convenience
The intervention intrusiveness (how easy is it to apply)
Time frame: during ICU admission.
Acceptability, effectiveness
Perception of whether the intervention helps manage the problem.
Time frame: during ICU admission.
Free of delirium
Number of delirium free days assessed by Confusion assessment method ICU (CAM-ICU)
Time frame: during ICU admission.
Anxiety, patients
Symptoms of anxiety, using Hospital Anxiety and Depression Scale
Time frame: 1 month post ICU admission
Depression, patients
Symptoms of depression using Hospital Anxiety and Depression Scale.
Time frame: 1 month post ICU admission
PTSD, patients
Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).
Time frame: 1 month post ICU admission
Health-related quality of life, patients
Assessed using EQ-5D
Time frame: 1 month post ICU admission
Free of life support
Days without mechanical ventilation, receiving vasopressors and undergoing dialysis.
Time frame: during ICU admission.
Survival
Days alive.
Time frame: 1 month post ICU admission
Employment status, patient
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Time frame: 1 month post ICU admission
Cognitive function
Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).
Time frame: 1 month post ICU admission
Out of hospital
Number of days out of hospital
Time frame: 1 month post ICU admission
Anxiety, family
Symptoms of anxiety using HADS
Time frame: 1 month post ICU admission
Depression, family
Symptoms of depression using HADS
Time frame: 1 post ICU admission
PTSD, family
Symptoms of PTSD using HTQ
Time frame: 1 month post ICU admission
Satisfaction, family
Survey for family-members regarding satisfaction.
Time frame: At ICU discharge.
Employment status, family
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Time frame: 1 month post ICU admission
Anxiety, patients
Symptoms of anxiety, using Hospital Anxiety and Depression Scale
Time frame: 6 months post ICU
Depression, patients
Symptoms of depression using Hospital Anxiety and Depression Scale.
Time frame: 6 months post ICU
PTSD, patients
Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).
Time frame: 6 months post ICU
Health-related quality of life, patients
Assessed using EQ-5D
Time frame: 6 months post ICU
Survival
Days alive.
Time frame: 6 months post ICU
Employment status, patient
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Time frame: 6 months post ICU
Cognitive function
Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).
Time frame: 6 months post ICU
Anxiety, family
Symptoms of anxiety using HADS
Time frame: 6 months post ICU
Depression, family
Symptoms of depression using HADS
Time frame: 6 months post ICU
PTSD, family
Symptoms of PTSD using HTQ
Time frame: 6 months post ICU
Employment status
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Time frame: 6 months post ICU
Employment status, family
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Time frame: 6 months post ICU
Out of hospital
Number of days out of hospital
Time frame: 6 months post ICU
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