Post-Intensive Care SyndromeIMPRESSNCT06118606
Pilot Study of a Multidisciplinary Intervention in ICU Survivors at Risk for Psychological or Physical Morbidity
A study testing Case-manager led multidisciplinary follow-up after intensive care in people with Post-Intensive Care Syndrome and Depressive Symptoms, run by Region Stockholm at 2 sites in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome, Depressive Symptoms, Anxiety
- What is being tested?
- Case-manager led multidisciplinary follow-up after intensive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Feb 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU/PREPICS instruments)
Who cannot join
- Dementia or other major cognitive problems
- Structural brain or spinal cord injury
- Multiple limitations of medical treatment
- Insufficient language skills (Swedish)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
ICU Karolinska University Hospital
Stockholm, 113 45
ICU Södersjukhuset
Stockholm
About this study
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
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
Read the 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
- Being tested
- Case-manager led multidisciplinary follow-up after intensive care
- Keywords
- Post-intensive care syndrome, Pilot study, Early follow-up intervention
- Medical subject headings
- postintensive care syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-manager led multidisciplinary follow-up after intensive careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Intervention arm Receives: Other: Case-manager led multidisciplinary follow-up after intensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Evaluation of the method including resource utilization with involved ICU follow-up staff/case managers and patients and their informal caregivers.
Measured: Outcome measured during and after termination of data collection and end of intervention
Utility of the intervention
Patient and caregiver views on the intervention's utility. Views on the intervention from hospital ward staff.
Measured: Outcome measured three-four months after ICU discharge
Secondary outcomes (5)
Depressive symptoms post-ICU
Assessment of patients' symptoms of depression post-intervention
Measured: Outcome measured three months after ICU discharge
Anxiety symptoms post-ICU
Assessment of patients' symptoms of anxiety post-intervention
Measured: Outcome measured three months after ICU discharge
Symptoms of post-traumatic stress post-ICU
Assessment of patients' symptoms of post-traumatic stress post-intervention
Measured: Outcome measured three months after ICU discharge
Physical disability post-ICU
Assessment of physical performance post-intervention
Measured: Outcome measured three months after ICU discharge
Health-related quality of life post-ICU
Health-related quality of life (HRQL) assessed with the RAND-36 questionnaire, scoring 0-100 where a higher score indicates greater HRQL.
Measured: Outcome measured three months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Feb 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Why it stopped: For logistical reasons at one study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study of the feasibility of the intervention
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anna Milton, Region Stockholm
- Investigators
- Anna Milton, Principal investigator, Karolinska Institutet/Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118606
- Sponsor's protocol ID
- 2022-03436-01
- Acronym
- IMPRESS
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06118606
- Acronym / sponsor ID
- IMPRESS / 2022-03436-01
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For logistical reasons at one study site.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of the feasibility of the intervention
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: Case-manager led multidisciplinary follow-up after intensive careIntervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU/PREPICS instruments)
Key exclusion criteria (4 listed)
- Dementia or other major cognitive problems
- Structural brain or spinal cord injury
- Multiple limitations of medical treatment
- Insufficient language skills (Swedish)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case-manager led multidisciplinary follow-up after intensive careEarly 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. | Other | Interventional arm |
Primary outcome
Feasibility of the intervention
Time frame: 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.
Utility of the intervention
Time frame: 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.
5 secondary outcomes
Depressive symptoms post-ICU
Time frame: Outcome measured three months after ICU discharge
Anxiety symptoms post-ICU
Time frame: Outcome measured three months after ICU discharge
Symptoms of post-traumatic stress post-ICU
Time frame: Outcome measured three months after ICU discharge
Physical disability post-ICU
Time frame: Outcome measured three months after ICU discharge
Health-related quality of life post-ICU
Time frame: Outcome measured three months after ICU discharge
Results and safety
The study was stopped early (reason given: For logistical reasons at one study site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Milton principal investigator
Karolinska Institutet/Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case-manager led multidisciplinary follow-up after intensive care in people with Post-Intensive Care Syndrome and Depressive Symptoms, run by Region Stockholm at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: For logistical reasons at one study site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Outcome measured during and after termination of data collection and end of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.