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

Not Applicable

Recruiting

• Conditions: Post-Intensive Care Syndrome; Depressive Symptoms; Anxiety; Physical Disability; Posttraumatic Stress Symptom; Critical Care, Intensive Care
• Interventions: Other: Case-manager led multidisciplinary follow-up after intensive care

• Registration Number: NCT06118606
• Lead Sponsor: Region Stockholm

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.

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Study Start: 2024-02-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	Case-manager led multidisciplinary follow-up after intensive care	Intervention arm

Primary Outcome Measures

Name	Time	Method
Utility of the intervention	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	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 Outcome Measures

Name	Time	Method
Depressive symptoms post-ICU	Outcome measured three months after ICU discharge	Assessment of patients' symptoms of depression post-intervention
Anxiety symptoms post-ICU	Outcome measured three months after ICU discharge	Assessment of patients' symptoms of anxiety post-intervention
Symptoms of post-traumatic stress post-ICU	Outcome measured three months after ICU discharge	Assessment of patients' symptoms of post-traumatic stress post-intervention
Physical disability post-ICU	Outcome measured three months after ICU discharge	Assessment of physical performance post-intervention
Health-related quality of life post-ICU	Outcome measured three months after ICU discharge	Health-related quality of life (HRQL) assessed with the RAND-36 questionnaire, scoring 0-100 where a higher score indicates greater HRQL.

Trial Locations

Locations (2)

ICU Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

ICU Södersjukhuset; 🇸🇪 Stockholm, Sweden