Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge

NCT05266118 | Completed

• 1 other identifier: 361816
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 2

Brief Summary

The overall objective of this study is a) to increase knowledge about ICU patient's symptoms and symptom clusters during the first week after ICU discharge, and b) to identify cognitive, psychological, and physical symptoms and health state at hospital discharge.

Conditions

Symptoms and Signs; Symptom Cluster; Follow-up Care; Critical Illness

Keywords

Critical ill; PICS; Ward; Follow-up care; Symptoms and Signs

Outcome Measures

Primary Outcomes (1)

• Multiple symptoms

  Multiple symptoms is measured with the Memorial Symptoms Assessment Scale (MSAS).The patients will be asked to indicate whether they experience 32 different symptoms (i.e., occurence). Those who experience a symptom will be asked to rate its frequency (from rarely \[1 point\] to almost constantly \[4 points\]); intensity (from slight \[1 p\] to very severe \[4 p\]); and distress or bother (from not at all \[0 p\] to very much \[4 p\]). Here, higher score indicate worse symptom experience.

  Up to 1 week after ICU discharge

Secondary Outcomes (6)

• Cognitive symptoms

  At hospital discharge, an average of one week

• Posttraumatic stress symptoms

  At hospital discharge, an average of one week

• Anxiety and depression

  At hospital discharge, an average of one week

• Physical symptoms

  At hospital discharge, an average of one week

• Health status

  At hospital discharge, an average of one week

Study Arms (1)

Former ICU patients

Participants is former ICU patients, immediately after transferred from ICU to a hospital ward. At least one of these criteria is needed for the participation in the study: ICU stays \> 24 hours; ventilatory support; transferals to other ICU \< 24 hours; continuous infusion of vasoactive substances. In addition, to be included, the patients must be more than 18 years of age; understand and be able to write and read Norwegian; be able to communicate verbally; not have a manifest cognitive deficit; and not being readmitted to ICU \< 72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target group of this study is former ICU patients. The patients will be recruited from a hospital in the South-Eastern part of Norway. In this hospital, ICU patients are treated in two different ICUs, one eight-bed mixed medical/surgical ICU (treating patients with both non-invasive and invasive mechanical ventilation) and one ten-bed medical ICU (treating patients with non-invasive ventilation only). The hospital wards may be both surgical and medical wards.

You may qualify if:

• At least one of these criteria is needed for the participation in the study:
• ICU stays \> 24 hours
• Ventilatory support
• Transferals to other ICU \< 24 hours
• Continuous infusion of vasoactive substances

You may not qualify if:

• Not able to understand, read or write Norwegian
• Not able to communicate verbally
• A manifest cognitive deficit (e.g., dementia or delirium)
• Re-admission to ICU \< 72 timer

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Norwegian Nurses Organisation: collaborator

Study Sites (2)

Ostfold Hospital Trust

Sarpsborg, Gralum, 1714, Norway

Location

Østfold Hospital Trust

Sarpsborg, Gralum, 1714, Norway

Location

MeSH Terms

Conditions

Signs and Symptoms; Syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Disease; Pathologic Processes; Disease Attributes

Study Officials

• Brita Fosser Olsen, RN,PhD

  Østfold Hospital Trust Postbox 300, 1714 Grålum, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: March 4, 2022
• Study Start: April 19, 2022
• Primary Completion: December 21, 2022
• Study Completion: March 2, 2023
• Last Updated: March 29, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)