Clinical trial NCT06974214: Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
Official title: Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: Patient- and family-centerede care
Feasibility
ICU
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We will conduct a pre-/post two-group study design.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Feasibility, recruitment rate
timeFrame: during ICU admission.
measure: Feasibility, Retention rate
timeFrame: 1 month post ICU admission
measure: Feasibility, Fidelity
timeFrame: during ICU admission.
measure: Acceptability, Adherence
timeFrame: during ICU admission.
measure: Acceptability, Appropriateness
timeFrame: during ICU admission.
measure: Acceptability, Convenience
timeFrame: during ICU admission.
measure: Acceptability, effectiveness
timeFrame: during ICU admission.
Secondary outcomes:
measure: Free of delirium
timeFrame: during ICU admission.
measure: Anxiety, patients
timeFrame: 1 month post ICU admission
measure: Depression, patients
timeFrame: 1 month post ICU admission
measure: PTSD, patients
timeFrame: 1 month post ICU admission
measure: Health-related quality of life, patients
timeFrame: 1 month post ICU admission
measure: Free of life support
timeFrame: during ICU admission.
measure: Survival
timeFrame: 1 month post ICU admission
measure: Employment status, patient
timeFrame: 1 month post ICU admission
measure: Cognitive function
timeFrame: 1 month post ICU admission
measure: Out of hospital
timeFrame: 1 month post ICU admission
measure: Anxiety, family
timeFrame: 1 month post ICU admission
measure: Depression, family
timeFrame: 1 post ICU admission
measure: PTSD, family
timeFrame: 1 month post ICU admission
measure: Satisfaction, family
timeFrame: At ICU discharge.
measure: Employment status, family
timeFrame: 1 month post ICU admission
measure: Anxiety, patients
timeFrame: 6 months post ICU
measure: Depression, patients
timeFrame: 6 months post ICU
measure: PTSD, patients
timeFrame: 6 months post ICU
measure: Health-related quality of life, patients
timeFrame: 6 months post ICU
measure: Survival
timeFrame: 6 months post ICU
measure: Employment status, patient
timeFrame: 6 months post ICU
measure: Cognitive function
timeFrame: 6 months post ICU
measure: Anxiety, family
timeFrame: 6 months post ICU
measure: Depression, family
timeFrame: 6 months post ICU
measure: PTSD, family
timeFrame: 6 months post ICU
measure: Employment status
timeFrame: 6 months post ICU
measure: Employment status, family
timeFrame: 6 months post ICU
measure: Out of hospital
timeFrame: 6 months post ICU
Other outcomes:
Locations:
Study officials:
References:
citation: 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.