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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06118606
Acronym
IMPRESS
Enrollment
41
Registered
2023-11-07
Start date
2024-02-01
Completion date
2025-03-30
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERCase-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.

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Pilot study of the feasibility of the intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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/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)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the interventionOutcome measured during and after termination of data collection and end of interventionEvaluation of the method including resource utilization with involved ICU follow-up staff/case managers and patients and their informal caregivers.
Utility of the interventionOutcome measured three-four months after ICU dischargePatient and caregiver views on the intervention's utility. Views on the intervention from hospital ward staff.

Secondary

MeasureTime frameDescription
Depressive symptoms post-ICUOutcome measured three months after ICU dischargeAssessment of patients' symptoms of depression post-intervention
Anxiety symptoms post-ICUOutcome measured three months after ICU dischargeAssessment of patients' symptoms of anxiety post-intervention
Symptoms of post-traumatic stress post-ICUOutcome measured three months after ICU dischargeAssessment of patients' symptoms of post-traumatic stress post-intervention
Physical disability post-ICUOutcome measured three months after ICU dischargeAssessment of physical performance post-intervention
Health-related quality of life post-ICUOutcome measured three months after ICU dischargeHealth-related quality of life (HRQL) assessed with the RAND-36 questionnaire, scoring 0-100 where a higher score indicates greater HRQL.

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORAnna Milton

Karolinska Institutet/Karolinska University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026