Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06974214

Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility 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

. 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FAM-ICU

Other

This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice.

Primary outcomes

  1. Feasibility, recruitment rate

    Time frame: during ICU admission.

    Number of approached participants who consent to participate.

  2. Feasibility, Retention rate

    Time frame: 1 month post ICU admission

    The number of non-responders to the self-reported questionnaires at 6 months.

  3. 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.

  4. Acceptability, Adherence

    Time frame: during ICU admission.

    Willingness to follow the intervention (Including barriers and facilitators).

  5. Acceptability, Appropriateness

    Time frame: during ICU admission.

    Perception of how suitable the intervention is for the target population,

  6. Acceptability, Convenience

    Time frame: during ICU admission.

    The intervention intrusiveness (how easy is it to apply)

  7. Acceptability, effectiveness

    Time frame: during ICU admission.

    Perception of whether the intervention helps manage the problem.

Secondary outcomes

  1. Free of delirium

    Time frame: during ICU admission.

    Number of delirium free days assessed by Confusion assessment method ICU (CAM-ICU)

  2. Anxiety, patients

    Time frame: 1 month post ICU admission

    Symptoms of anxiety, using Hospital Anxiety and Depression Scale

  3. Depression, patients

    Time frame: 1 month post ICU admission

    Symptoms of depression using Hospital Anxiety and Depression Scale.

  4. PTSD, patients

    Time frame: 1 month post ICU admission

    Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).

  5. Health-related quality of life, patients

    Time frame: 1 month post ICU admission

    Assessed using EQ-5D

  6. Free of life support

    Time frame: during ICU admission.

    Days without mechanical ventilation, receiving vasopressors and undergoing dialysis.

  7. Survival

    Time frame: 1 month post ICU admission

    Days alive.

  8. Employment status, patient

    Time frame: 1 month post ICU admission

    Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.

  9. Cognitive function

    Time frame: 1 month post ICU admission

    Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).

  10. Out of hospital

    Time frame: 1 month post ICU admission

    Number of days out of hospital

  11. Anxiety, family

    Time frame: 1 month post ICU admission

    Symptoms of anxiety using HADS

  12. Depression, family

    Time frame: 1 post ICU admission

    Symptoms of depression using HADS

  13. PTSD, family

    Time frame: 1 month post ICU admission

    Symptoms of PTSD using HTQ

  14. Satisfaction, family

    Time frame: At ICU discharge.

    Survey for family-members regarding satisfaction.

  15. Employment status, family

    Time frame: 1 month post ICU admission

    Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.

  16. Anxiety, patients

    Time frame: 6 months post ICU

    Symptoms of anxiety, using Hospital Anxiety and Depression Scale

  17. Depression, patients

    Time frame: 6 months post ICU

    Symptoms of depression using Hospital Anxiety and Depression Scale.

  18. PTSD, patients

    Time frame: 6 months post ICU

    Symptoms of PTSD using Harvard Trauma Questionnaire part 4 (HTQ-lV).

  19. Health-related quality of life, patients

    Time frame: 6 months post ICU

    Assessed using EQ-5D

  20. Survival

    Time frame: 6 months post ICU

    Days alive.

  21. Employment status, patient

    Time frame: 6 months post ICU

    Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.

  22. Cognitive function

    Time frame: 6 months post ICU

    Assessed using Mini Montreal Cognitive Assessment (Mini MoCA).

  23. Anxiety, family

    Time frame: 6 months post ICU

    Symptoms of anxiety using HADS

  24. Depression, family

    Time frame: 6 months post ICU

    Symptoms of depression using HADS

  25. PTSD, family

    Time frame: 6 months post ICU

    Symptoms of PTSD using HTQ

  26. Employment status

    Time frame: 6 months post ICU

    Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.

  27. Employment status, family

    Time frame: 6 months post ICU

    Employment as full-time, part-time, unemployed, self-employed, (paid/unpaid) on leave, student, or retired.

  28. Out of hospital

    Time frame: 6 months post ICU

    Number of days out of hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Søs Bohart, PhD

CONTACT

[email protected]

0045 38 68 91 86

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Acronym: FAM-ICU

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.