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

NCT06118606 | Recruiting

• 1 other identifier: 2022-03436-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

Post-intensive care syndrome; Pilot study; Early follow-up intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 Arms (1)

Interventional arm

EXPERIMENTAL

Intervention arm

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

Interventions

Case-manager led multidisciplinary follow-up after intensive care OTHER

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (2)

ICU Karolinska University Hospital

Stockholm, 113 45, Sweden

NOT YET RECRUITING

ICU Södersjukhuset

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Anna Milton

  Karolinska Institutet/Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Milton, PhD

CONTACT

+46812370000; anna.milton@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Pilot study of the feasibility of the intervention

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)