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Clinical Trials/NCT06118606
NCT06118606
Recruiting
N/A

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 sites in 1 country60 target enrollmentFebruary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-Intensive Care Syndrome
Sponsor
Region Stockholm
Enrollment
60
Locations
2
Primary Endpoint
Utility of the intervention
Status
Recruiting
Last Updated
last year

Overview

Brief 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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
April 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Milton

Principal investigator

Region Stockholm

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Utility of the intervention

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (2)

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