Pilot Study of a Multidisciplinary Intervention in ICU Survivors at Risk for Psychological or Physical Morbidity

Study Overview
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Brief Summary
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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

Detailed Description
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60 adult patients at three hospitals in Region Stockholm (Karolinska University Hospital, Södersjukhuset and Capio S:t Görans Hospital) with an ICU stay ≥12 hours. Exclusion criteria are dementia, structural brain or spinal cord injury and multiple limitations of medical treatment. Eligibility screening: Patients with an increased risk for physical disability or psychological morbidity three months after ICU discharge (assessed with the PROGRESS-ICU/PREPICS instruments) 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 focus groups where semi-structured interviews will deepen the knowledge about their needs and suggested measures to improve the patients' recovery. Resource utilisation will be documented by the CM and feedback collected from hospital clinicians and primary care providers. Secondary outcome is patients' level of psychological and physical problems.

Official Title
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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

Conditions
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Posttraumatic Stress Symptom, Post-Intensive Care Syndrome, Depressive Symptoms, Anxiety, Physical Disability

Intervention / Treatment
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* Other: Case-manager led multidisciplinary follow-up after intensive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU instruments) Exclusion Criteria: Dementia or other major cognitive problems Structural brain or spinal cord injury Multiple limitations of medical treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study of the feasibility of the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>Intervention arm | Other: Case-manager led multidisciplinary follow-up after intensive care<br>* Early in-hospital follow-up in survivors of intensive care with an increased risk of psychological/physical sequelae. The follow-up is led by a case-manager reassessing the patient after ICU discharge for psychological/physical rehabilitation needs. The CM will discuss patient needs with concerned specialists in a multidisciplinary team, leading to the establishment of a personal rehabilitation plan, communicated to the patient and next-of-kin. The CM will keep track of the patient during hospital stay and ensure primary care rehabilitation (if needed) is established once the patient is discharged from the hospital. The CM will contact the patient weekly to follow up on well-being and primary care activities until 12 weeks after discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | Evaluation of the method including resource utilization with involved ICU follow-up staff/case managers and patients and their informal caregivers. | Outcome measured during and after termination of data collection and end of intervention | 
| Utility of the intervention | Patient and caregiver views on the intervention's utility. Views on the intervention from hospital ward staff. | Outcome measured three-four months after ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms post-ICU | Assessment of patients' symptoms of depression post-intervention | Outcome measured three months after ICU discharge | 
| Anxiety symptoms post-ICU | Assessment of patients' symptoms of anxiety post-intervention | Outcome measured three months after ICU discharge | 
| Symptoms of post-traumatic stress post-ICU | Assessment of patients' symptoms of post-traumatic stress post-intervention | Outcome measured three months after ICU discharge | 
| Physical disability post-ICU | Assessment of physical performance post-intervention | Outcome measured three months after ICU discharge |