Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
- Conditions
- DeliriumPost Intensive Care Unit SyndromePost Intensive Care Unit Syndrome FamilyDepressionPosttraumatic Stress Disorder (PTSD)MortalityLength of ICU StayPainSatisfaction SurveyAnxiety
- Registration Number
- NCT06974214
- Lead Sponsor
- Herlev Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Acceptability, Adherence during ICU admission. Willingness to follow the intervention (Including barriers and facilitators).
Acceptability, Convenience during ICU admission. The intervention intrusiveness (how easy is it to apply)
Feasibility, Retention rate 1 month post ICU admission The number of non-responders to the self-reported questionnaires at 6 months.
Acceptability, Appropriateness during ICU admission. Perception of how suitable the intervention is for the target population,
Feasibility, Fidelity during ICU admission. The frequency and resource use of intervention delivery. Free text describing experienced barriers and facilitators for completing/not completing an intervention component.
Feasibility, recruitment rate during ICU admission. Number of approached participants who consent to participate.
Acceptability, effectiveness during ICU admission. Perception of whether the intervention helps manage the problem.
- Secondary Outcome Measures
Name Time Method Employment status, patient 6 months post ICU Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Cognitive function 6 months post ICU Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).
Out of hospital 6 months post ICU Number of days out of hospital
Anxiety, family 6 months post ICU Symptoms of anxiety using HADS
Depression, family 6 months post ICU Symptoms of depression using HADS
PTSD, family 6 months post ICU Symptoms of PTSD using HTQ
Satisfaction, family At ICU discharge. Survey for family-members regarding satisfaction.
Employment status, family 6 months post ICU Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Employment status 6 months post ICU Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
PTSD, patients 6 months post ICU Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).
Health-related quality of life, patients 6 months post ICU Assessed using EQ-5D
Free of life support during ICU admission. Days without mechanical ventilation, receiving vasopressors and undergoing dialysis.
Survival 6 months post ICU Days alive.
Free of delirium during ICU admission. Number of delirium free days assessed by Confusion assessment method ICU (CAM-ICU)
Anxiety, patients 6 months post ICU Symptoms of anxiety, using Hospital Anxiety and Depression Scale
Depression, patients 6 months post ICU Symptoms of depression using Hospital Anxiety and Depression Scale.