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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Case-manager led multidisciplinary follow-up after intensive care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Outcome measured three-four months after ICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms post-ICU | Assessment of patients' symptoms of depression post-intervention | Outcome measured three months after ICU discharge |
| Anxiety symptoms post-ICU | Assessment of patients' symptoms of anxiety post-intervention |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Milton, PhD | Contact | +46812370000 | anna.milton@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Anna Milton | Karolinska Institutet/Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU Karolinska University Hospital | Not yet recruiting | Stockholm | 113 45 | Sweden |
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Pilot study of the feasibility of the intervention
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| Outcome measured three months after ICU discharge |
| Symptoms of post-traumatic stress post-ICU | Assessment of patients' symptoms of post-traumatic stress post-intervention | Outcome measured three months after ICU discharge |
| Physical disability post-ICU | Assessment of physical performance post-intervention | 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. | Outcome measured three months after ICU discharge |
| ICU Södersjukhuset | Recruiting | Stockholm | Sweden |
|
| ID | Term |
|---|---|
| C000657744 | postintensive care syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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