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

NCT ID: NCT06118606

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interventional arm

Intervention arm

Group Type: EXPERIMENTAL

Case-manager led multidisciplinary follow-up after intensive care

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anna Milton

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Milton

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet/Karolinska University Hospital

Locations

ICU Karolinska University Hospital

Stockholm, , Sweden

Site Status: NOT_YET_RECRUITING

ICU Södersjukhuset

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Anna Milton, PhD

Role: CONTACT

anna.milton@regionstockholm.se

+46812370000

Facility Contacts

Anna Milton, PhD

Role: primary

anna.milton@regionstockholm.se

Anna Schandl, Docent

Role: primary

anna.schandl@regionstockholm.se

Katinka Siesage

Role: backup

katinka.siesage@regionstockholm.se

Other Identifiers

2022-03436-01

Identifier Type: -

Identifier Source: org_study_id