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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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usual care

The group receives usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

FAM-ICU intervention

The group receives the FAM-ICU intervention

Group Type EXPERIMENTAL

FAM-ICU

Intervention Type OTHER

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

Interventions

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FAM-ICU

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes