Clinical trial NCT06118606: Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of the feasibility of the intervention
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Outcome measured during and after termination of data collection and end of intervention
measure: Utility of the intervention
timeFrame: Outcome measured three-four months after ICU discharge
Secondary outcomes:
measure: Depressive symptoms post-ICU
timeFrame: Outcome measured three months after ICU discharge
measure: Anxiety symptoms post-ICU
timeFrame: Outcome measured three months after ICU discharge
measure: Symptoms of post-traumatic stress post-ICU
timeFrame: Outcome measured three months after ICU discharge
measure: Physical disability post-ICU
timeFrame: Outcome measured three months after ICU discharge
measure: Health-related quality of life post-ICU
timeFrame: Outcome measured three months after ICU discharge
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: ICU Karolinska University Hospital
city: Stockholm
country: Sweden
facility: ICU Södersjukhuset
Study officials:
affiliation: Karolinska Institutet/Karolinska University Hospital
name: Anna Milton
role: PRINCIPAL_INVESTIGATOR
References: