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

NCT06974214 | Not Yet Recruiting

• 1 other identifier: Herlev Hospital
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (7)

• Feasibility, recruitment rate

  Number of approached participants who consent to participate.

  during ICU admission.

• Feasibility, Retention rate

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

  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.

  during ICU admission.

• Acceptability, Adherence

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

  during ICU admission.

• Acceptability, Appropriateness

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

  during ICU admission.

• Acceptability, Convenience

  The intervention intrusiveness (how easy is it to apply)

  during ICU admission.

• Acceptability, effectiveness

  Perception of whether the intervention helps manage the problem.

  during ICU admission.

Secondary Outcomes (28)

• Free of delirium

  during ICU admission.

• Anxiety, patients

  1 month post ICU admission

• Depression, patients

  1 month post ICU admission

• PTSD, patients

  1 month post ICU admission

• Health-related quality of life, patients

  1 month post ICU admission

Study Arms (2)

usual care

NO INTERVENTION

The group receives usual care.

FAM-ICU intervention

EXPERIMENTAL

The group receives the FAM-ICU intervention

Other: FAM-ICU

Interventions

FAM-ICU OTHER

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

FAM-ICU intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Herlev Hospital: lead

Related Publications (1)

• 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.

  PMID: 39445615 RESULT

MeSH Terms

Conditions

Delirium; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Pain

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Søs Bohart, PhD

CONTACT

0045 38 68 91 86; soes.bohart@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postdoc.

Model Details: We will conduct a pre-/post two-group study design.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 15, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05