Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Feasibility, recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
FAM-ICU intervention
The group receives the FAM-ICU intervention
干预措施: FAM-ICU (Other)
usual care
The group receives usual care.
结局指标
主要结局
Feasibility, recruitment rate
时间窗: during ICU admission.
Number of approached participants who consent to participate.
Acceptability, effectiveness
时间窗: during ICU admission.
Perception of whether the intervention helps manage the problem.
Feasibility, Retention rate
时间窗: 1 month post ICU admission
The number of non-responders to the self-reported questionnaires at 6 months.
Feasibility, Fidelity
时间窗: 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, Appropriateness
时间窗: during ICU admission.
Perception of how suitable the intervention is for the target population,
Acceptability, Adherence
时间窗: during ICU admission.
Willingness to follow the intervention (Including barriers and facilitators).
Acceptability, Convenience
时间窗: during ICU admission.
The intervention intrusiveness (how easy is it to apply)
次要结局
- Health-related quality of life, patients(6 months post ICU)
- Free of delirium(during ICU admission.)
- Anxiety, patients(6 months post ICU)
- Depression, patients(6 months post ICU)
- PTSD, patients(6 months post ICU)
- Free of life support(during ICU admission.)
- Survival(6 months post ICU)
- Employment status, patient(6 months post ICU)
- Cognitive function(6 months post ICU)
- Out of hospital(6 months post ICU)
- Anxiety, family(6 months post ICU)
- Depression, family(6 months post ICU)
- PTSD, family(6 months post ICU)
- Satisfaction, family(At ICU discharge.)
- Employment status, family(6 months post ICU)
- Employment status(6 months post ICU)
- Depression, patients(1 month post ICU admission)
- Anxiety, patients(1 month post ICU admission)
- PTSD, patients(1 month post ICU admission)
- Health-related quality of life, patients(1 month post ICU admission)
- Survival(1 month post ICU admission)
- Employment status, patient(1 month post ICU admission)
- Cognitive function(1 month post ICU admission)
- Out of hospital(1 month post ICU admission)
- Anxiety, family(1 month post ICU admission)
- Depression, family(1 post ICU admission)
- PTSD, family(1 month post ICU admission)
- Employment status, family(1 month post ICU admission)