Anxiety, Delirium, Depression, Length of ICU Stay, Mortality, Pain, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family, Posttraumatic Stress Disorder (PTSD), Satisfaction Survey
Conditions
Keywords
Patient- and family-centerede care, Feasibility, ICU
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.
Interventions
OTHERFAM-ICU
This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice.
Sponsors
Herlev Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
We will conduct a pre-/post two-group study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, recruitment rate | during ICU admission. | Number of approached participants who consent to participate. |
| Feasibility, Retention rate | 1 month post ICU admission | The number of non-responders to the self-reported questionnaires at 6 months. |
| 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. |
| Acceptability, Adherence | during ICU admission. | Willingness to follow the intervention (Including barriers and facilitators). |
| Acceptability, Appropriateness | during ICU admission. | Perception of how suitable the intervention is for the target population, |
| Acceptability, Convenience | during ICU admission. | The intervention intrusiveness (how easy is it to apply) |
| Acceptability, effectiveness | during ICU admission. | Perception of whether the intervention helps manage the problem. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Employment status, patient | 1 month post ICU admission | Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired. |
| Cognitive function | 1 month post ICU admission | Assessed using Mini Montreal Cognitive Assessment (Mini MoCA). |
| Out of hospital | 1 month post ICU admission | Number of days out of hospital |
| Anxiety, family | 1 month post ICU admission | Symptoms of anxiety using HADS |
| Free of delirium | during ICU admission. | Number of delirium free days assessed by Confusion assessment method ICU (CAM-ICU) |
| PTSD, family | 1 month post ICU admission | Symptoms of PTSD using HTQ |
| Satisfaction, family | At ICU discharge. | Survey for family-members regarding satisfaction. |
| Employment status, family | 1 month post ICU admission | 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. |
| Depression, family | 1 post ICU admission | Symptoms of depression using HADS |
| Anxiety, patients | 1 month post ICU admission | Symptoms of anxiety, using Hospital Anxiety and Depression Scale |
| Depression, patients | 1 month post ICU admission | Symptoms of depression using Hospital Anxiety and Depression Scale. |
| PTSD, patients | 1 month post ICU admission | Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV). |
| Health-related quality of life, patients | 1 month post ICU admission | Assessed using EQ-5D |
| Free of life support | during ICU admission. | Days without mechanical ventilation, receiving vasopressors and undergoing dialysis. |
| Survival | 1 month post ICU admission | Days alive. |
Contacts
Primary ContactSøs Bohart, PhD
Outcome results
None listed