DeliriumFAM-ICUNCT06974214
Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
A study testing FAM-ICU in people with Delirium and Anxiety, run by Herlev Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Anxiety, Post Intensive Care Unit Syndrome
- What is being tested?
- FAM-ICU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
. 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.
- Conditions
- Delirium, Anxiety, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family, Depression, Posttraumatic Stress Disorder (PTSD)
- Being tested
- FAM-ICU
- Keywords
- Patient- and family-centerede care, Feasibility, ICU
- Medical subject headings
- Delirium, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAM-ICUOther
This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | The group receives usual care. |
| FAM-ICU intervention | Experimental | The group receives the FAM-ICU intervention Receives: Other: FAM-ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, recruitment rate
Number of approached participants who consent to participate.
Measured: during ICU admission.
Feasibility, Retention rate
The number of non-responders to the self-reported questionnaires at 6 months.
Measured: 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.
Measured: during ICU admission.
Acceptability, Adherence
Willingness to follow the intervention (Including barriers and facilitators).
Measured: during ICU admission.
Acceptability, Appropriateness
Perception of how suitable the intervention is for the target population,
Measured: during ICU admission.
Acceptability, Convenience
The intervention intrusiveness (how easy is it to apply)
Measured: during ICU admission.
Acceptability, effectiveness
Perception of whether the intervention helps manage the problem.
Measured: during ICU admission.
Secondary outcomes (28)
Free of delirium
Number of delirium free days assessed by Confusion assessment method ICU (CAM-ICU)
Measured: during ICU admission.
Anxiety, patients
Symptoms of anxiety, using Hospital Anxiety and Depression Scale
Measured: 1 month post ICU admission
Depression, patients
Symptoms of depression using Hospital Anxiety and Depression Scale.
Measured: 1 month post ICU admission
PTSD, patients
Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).
Measured: 1 month post ICU admission
Health-related quality of life, patients
Assessed using EQ-5D
Measured: 1 month post ICU admission
Free of life support
Days without mechanical ventilation, receiving vasopressors and undergoing dialysis.
Measured: during ICU admission.
Survival
Days alive.
Measured: 1 month post ICU admission
Employment status, patient
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Measured: 1 month post ICU admission
Cognitive function
Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).
Measured: 1 month post ICU admission
Out of hospital
Number of days out of hospital
Measured: 1 month post ICU admission
Anxiety, family
Symptoms of anxiety using HADS
Measured: 1 month post ICU admission
Depression, family
Symptoms of depression using HADS
Measured: 1 post ICU admission
PTSD, family
Symptoms of PTSD using HTQ
Measured: 1 month post ICU admission
Satisfaction, family
Survey for family-members regarding satisfaction.
Measured: At ICU discharge.
Employment status, family
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Measured: 1 month post ICU admission
Anxiety, patients
Symptoms of anxiety, using Hospital Anxiety and Depression Scale
Measured: 6 months post ICU
Depression, patients
Symptoms of depression using Hospital Anxiety and Depression Scale.
Measured: 6 months post ICU
PTSD, patients
Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).
Measured: 6 months post ICU
Health-related quality of life, patients
Assessed using EQ-5D
Measured: 6 months post ICU
Survival
Days alive.
Measured: 6 months post ICU
Employment status, patient
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Measured: 6 months post ICU
Cognitive function
Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).
Measured: 6 months post ICU
Anxiety, family
Symptoms of anxiety using HADS
Measured: 6 months post ICU
Depression, family
Symptoms of depression using HADS
Measured: 6 months post ICU
PTSD, family
Symptoms of PTSD using HTQ
Measured: 6 months post ICU
Employment status
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Measured: 6 months post ICU
Employment status, family
Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.
Measured: 6 months post ICU
Out of hospital
Number of days out of hospital
Measured: 6 months post ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Nov 2025
- Primary completion1 May 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- We will conduct a pre-/post two-group study design.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søs Bohart, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974214
- Sponsor's protocol ID
- Herlev Hospital
- Acronym
- FAM-ICU
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39445615
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06974214
- Acronym / sponsor ID
- FAM-ICU / Herlev Hospital
- Conditions
- Delirium, Anxiety, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family, Depression, Posttraumatic Stress Disorder (PTSD)
- Keywords
- Patient- and family-centerede care, Feasibility, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a pre-/post two-group study design.
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –The group receives usual care. |
| FAM-ICU intervention | Experimental | Other: FAM-ICUThe group receives the FAM-ICU intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAM-ICUThis multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice. | Other | FAM-ICU intervention |
Primary outcome
Feasibility, recruitment rate
Time frame: during ICU admission.
Number of approached participants who consent to participate.
Feasibility, Retention rate
Time frame: 1 month post ICU admission
The number of non-responders to the self-reported questionnaires at 6 months.
Feasibility, Fidelity
Time frame: 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
Time frame: during ICU admission.
Willingness to follow the intervention (Including barriers and facilitators).
Acceptability, Appropriateness
Time frame: during ICU admission.
Perception of how suitable the intervention is for the target population,
Acceptability, Convenience
Time frame: during ICU admission.
The intervention intrusiveness (how easy is it to apply)
Acceptability, effectiveness
Time frame: during ICU admission.
Perception of whether the intervention helps manage the problem.
28 secondary outcomes
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
PTSD, family
Time frame: 1 month post ICU admission
Satisfaction, family
Time frame: At ICU discharge.
Employment status, family
Time frame: 1 month post ICU admission
Anxiety, patients
Time frame: 6 months post ICU
Depression, patients
Time frame: 6 months post ICU
PTSD, patients
Time frame: 6 months post ICU
Health-related quality of life, patients
Time frame: 6 months post ICU
Survival
Time frame: 6 months post ICU
Employment status, patient
Time frame: 6 months post ICU
Cognitive function
Time frame: 6 months post ICU
Anxiety, family
Time frame: 6 months post ICU
Depression, family
Time frame: 6 months post ICU
PTSD, family
Time frame: 6 months post ICU
Employment status
Time frame: 6 months post ICU
Employment status, family
Time frame: 6 months post ICU
Out of hospital
Time frame: 6 months post ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 39445615Bohart 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAM-ICU in people with Delirium and Anxiety, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, recruitment rate (time frame: during ICU admission.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.