跳至主要内容
临床试验/NCT06118606
NCT06118606终止不适用

Interventional Multidisciplinary Rehabilitation and Special Support; a Pilot Study of a Case Manager-led Multidisciplinary Intervention in ICU Survivors at Risk for Psychological or Physical Morbidity -IMPRESS-ICU Pilot Study

Region Stockholm2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
41
试验地点
2
主要终点
Utility of the intervention

研究概览

简要总结

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

详细描述

60 adult patients at two hospitals in Region Stockholm (Karolinska University Hospital and Södersjukhuset) with an ICU stay ≥12 hours with increased risk for psychological/physical sequelae will be invited to participate.

Intervention: Early re-assessment and multidisciplinary follow-up, led by an ICU follow-up staff (Case Manager, CM). The CM will support the patient and coordinate the rehabilitation efforts from ICU discharge to primary care with a secondary, deepened assessment of symptoms in the ward, recapitulation and information about the time spent in the ICU, followed by a multidisciplinary discussion with concerned specialists and the set-up of an individual rehabilitation plan communicated to the patient and the informal caregivers. The CM will keep track of the patient during hospital stay and ensure that there is a plan for further primary care rehabilitation after hospital discharge. The CM will contact the patient weekly to follow up on wellbeing and planned primary care activities until 12 weeks. At twelve weeks, patients will be assessed with regards to psychological symptoms (HADS, PTSS-14) and physical disability (BI).

Outcome: The primary outcome is the feasibility of the intervention. Patients and informal caregivers will be invited to participate in semi-structured interviews that will deepen the knowledge about their views upon the intervention, needs and suggested measures to improve the patients' recovery. Resource utilisation will be documented by the CM and feedback collected from involved ICU staff and hospital clinicians. Secondary outcomes are patients' level of psychological and physical problems and health-related quality of life. The results from the pilot study will inform a subsequent randomized controlled trial of an early follow-up intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
否

入选标准

  • •- Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU/PREPICS instruments)

排除标准

  • •Dementia or other major cognitive problems
  • •Structural brain or spinal cord injury
  • •Multiple limitations of medical treatment
  • •Insufficient language skills (Swedish)

研究组 & 干预措施

Interventional arm

Experimental

Intervention arm

干预措施: Case-manager led multidisciplinary follow-up after intensive care (Other)

结局指标

主要结局

Utility of the intervention

时间窗: Outcome measured three-four months after ICU discharge

Patient and caregiver views on the intervention's utility. Views on the intervention from hospital ward staff.

Feasibility of the intervention

时间窗: Outcome measured during and after termination of data collection and end of intervention

Evaluation of the method including resource utilization with involved ICU follow-up staff/case managers and patients and their informal caregivers.

次要结局

  • Symptoms of post-traumatic stress post-ICU(Outcome measured three months after ICU discharge)
  • Physical disability post-ICU(Outcome measured three months after ICU discharge)
  • Depressive symptoms post-ICU(Outcome measured three months after ICU discharge)
  • Anxiety symptoms post-ICU(Outcome measured three months after ICU discharge)
  • Health-related quality of life post-ICU(Outcome measured three months after ICU discharge)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anna Milton

Principal investigator

Region Stockholm

研究点 (2)

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