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

Anxiety Clinical Trial

— IMPRESS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118606
• Other study ID #: 2022-03436-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Region Stockholm
• Contact: Anna Milton, PhD
• Phone: +46812370000
• Email: anna.milton[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Physical Disability
• Post-Intensive Care Syndrome

Intervention

Other:
• Case-manager led multidisciplinary follow-up after intensive care
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Depressive symptoms post-ICU	Assessment of patients' symptoms of depression post-intervention	Outcome measured three months after ICU discharge
Secondary	Anxiety symptoms post-ICU	Assessment of patients' symptoms of anxiety post-intervention	Outcome measured three months after ICU discharge
Secondary	Symptoms of post-traumatic stress post-ICU	Assessment of patients' symptoms of post-traumatic stress post-intervention	Outcome measured three months after ICU discharge
Secondary	Physical disability post-ICU	Assessment of physical performance post-intervention	Outcome measured three months after ICU discharge