← Back to searchRecruitingRecruiting
Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity
NCT06118606 · Region Stockholm
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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)
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-01
Estimated completion: 2025-04
Last updated: 2024-10-09
Interventions
Other: Case-manager led multidisciplinary follow-up after intensive care
Primary outcomes
- • Feasibility of the intervention (Outcome measured during and after termination of data collection and end of intervention)
- • Utility of the intervention (Outcome measured three-four months after ICU discharge)
Sponsor
Region Stockholm · other_gov
Contacts & investigators
ContactAnna Milton, PhD · contact · anna.milton@regionstockholm.se · +46812370000
InvestigatorAnna Milton · principal_investigator, Karolinska Institutet/Karolinska University Hospital
All locations (2)
ICU Karolinska University HospitalNot Yet Recruiting
Stockholm, Sweden
ICU SödersjukhusetRecruiting
Stockholm, Sweden