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

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 113 45
    • ICU Karolinska University Hospital
  • Stockholm, Sweden
    • ICU Södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional arm; Intervention arm

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.

What is the study measuring?

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
Health-related quality of life post-ICU	Health-related quality of life (HRQL) assessed with the RAND-36 questionnaire, scoring 0-100 where a higher score indicates greater HRQL.	Outcome measured three months after ICU discharge

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Anna Milton, Karolinska Institutet/Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pilot study; Post-intensive care syndrome; Early follow-up intervention
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; postintensive care syndrome
• Other Study ID Numbers: 2022-03436-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No