Longitudinal Prospective Study in a Mixed ICU Population

The Trajectory of Functional Status During the First Year After ICU Admission.

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Patients

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 603

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo Univesity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The sample population is adults patients admitted to the ICU.

Description

Inclusion Criteria

• Patients that are > 18 years and
• Meet the criteria of Norwegian Intensive Register (NIR) for being an intensive care patient. The criteria include any on the following criteria:
• The need of mechanical ventilation, or
• The need of continuous inotropi, or
• 24 hours or more on an ICU, when continuous monitoring is needed, or
• Dies at the ICU within the first 24 hours, or
• Transferred to another ICU within the first 24 hours

Exclusion Criteria:

• Re-admissions to the ICU (within 72 hours from last ICU discharge)
• Pre-defined cognitive deficit (e.g. dementia)
• Homeless
• Unable to read and Write Norwegian
• Not included in the study within the first 48 hours since admission to the ICU

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Copenhagen; University of California, San Francisco; South-Eastern Norway Regional Health Authority
• Investigators: Principal Investigator: Tone Rustøen, Professor, Oslo University Hospital and Oslo University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Functional status, Symptoms, Cognitive functioning, QOL
• Other Study ID Numbers: 2017/990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No