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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
| University of California, San Francisco | OTHER |
| University of Copenhagen | OTHER |
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Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported functional status during first year after an ICU admission.
For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.
The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).
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| Measure | Description | Time Frame |
|---|---|---|
| A cohort study on change of Functional Status during the first year after an ICU admission | Data on functional status will be collected using PROMS (e.g Katz index and Lawton IADL) at baseline, and then after 3, 6 and 12 months. | September 2018- May 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| The investigation of 5 pre-selected symptoms during the ICU stay | A modified version of the Patient Symptom Survey (PSS) checklist will be used as self-report by the ICU patient when possible or by the clinical nurse as a proxy reporter. | September 2018 - December 2020 |
| Cognitive functioning one year after ICU admission in a mixed ICU population |
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Inclusion Criteria
Exclusion Criteria:
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The sample population is adults patients admitted to the ICU.
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| Name | Affiliation | Role |
|---|---|---|
| Tone Rustøen, Professor | Oslo University Hospital and Oslo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Univesity hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39018966 | Derived | Saltnes-Lillegard C, Rustoen T, Beitland S, Puntillo K, Thoresen M, Hofso K. Subgroups of ICU patients identified by self-reported symptoms - A prospective multicenter study. Intensive Crit Care Nurs. 2024 Oct;84:103761. doi: 10.1016/j.iccn.2024.103761. Epub 2024 Jul 16. | |
| 37812229 | Derived | Saltnes-Lillegard C, Rustoen T, Beitland S, Puntillo K, Hagen M, Lerdal A, Hofso K. Self-reported symptoms experienced by intensive care unit patients: a prospective observational multicenter study. Intensive Care Med. 2023 Nov;49(11):1370-1382. doi: 10.1007/s00134-023-07219-0. Epub 2023 Oct 9. |
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Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire, and proxy reported by IQCODE and CFQ at baseline. |
| September 2018 - December 2020 |
| Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope | Posttraumatic stress symptoms will be measured using self-report with the Impact of event scale-revised questionnaire. Hope will be measured with the Herth Hope Index. | January 2020 - December 2021 |