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

Sponsor
Region Stockholm (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06118606
Collaborator
(none)
60
1
12

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Case-manager led multidisciplinary follow-up after intensive care
N/A

Detailed Description

60 adult patients at three hospitals in Region Stockholm (Karolinska University Hospital, Södersjukhuset and Capio S:t Görans Hospital) with an ICU stay ≥12 hours. Exclusion criteria are dementia, structural brain or spinal cord injury and multiple limitations of medical treatment.

Eligibility screening: Patients with an increased risk for physical disability or psychological morbidity three months after ICU discharge (assessed with the PROGRESS-ICU/PREPICS instruments) 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 focus groups where semi-structured interviews will deepen the knowledge about their needs and suggested measures to improve the patients' recovery. Resource utilisation will be documented by the CM and feedback collected from hospital clinicians and primary care providers. Secondary outcome is patients' level of psychological and physical problems.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot study of the feasibility of the interventionPilot study of the feasibility of the intervention
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. Depressive symptoms post-ICU [Outcome measured three months after ICU discharge]

    Assessment of patients' symptoms of depression post-intervention

  2. Anxiety symptoms post-ICU [Outcome measured three months after ICU discharge]

    Assessment of patients' symptoms of anxiety post-intervention

  3. Symptoms of post-traumatic stress post-ICU [Outcome measured three months after ICU discharge]

    Assessment of patients' symptoms of post-traumatic stress post-intervention

  4. Physical disability post-ICU [Outcome measured three months after ICU discharge]

    Assessment of physical performance post-intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU instruments)
Exclusion Criteria:
  • Dementia or other major cognitive problems

  • Structural brain or spinal cord injury

  • Multiple limitations of medical treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Region Stockholm

Investigators

  • Principal Investigator: Anna Milton, Karolinska Institutet/Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Milton, Principal investigator, Region Stockholm
ClinicalTrials.gov Identifier:
NCT06118606
Other Study ID Numbers:
  • 2022-03436-01
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023