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

NCT ID: NCT05266118

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2023-03-02

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.

Detailed Description

Several studies have examined how ICU patients experience being in the ICU, and up to 75% of ICU patients experience multiple intensive care related symptoms while in the ICU. Other studies have examined ICU patients' transfer from ICU to hospital wards, and the transfer may cause mixed emotions for the patient, both positive perception of an improvement in the patient's condition, but also negative perception of decreased monitoring of the patient and less staff involvement in their care. Further, extensive literature exists examining the long-term effects of being an ICU patient, and a major proportion of ICU survivors develop a combination of cognitive, psychological, and physical symptoms, which can persist for months or even years after hospital discharge. This phenomena is now recognized as post intensive care syndrome (PICS). These consequences are associated with a combination of reduced quality of life, impaired functional status and impaired daily functioning, and has consequences for both ICU survivors and their families. However, studies about what ICU patients' experience just after ICU discharge (in hospital wards), is scarce. In this time, patients are still in need of advanced personalized care after having survived critical illness and intensive care treatment.

This study will increase knowledge about symptoms and symptom clusters in ICU patients during the first week after ICU discharge, and at hospital discharge. In these areas, evidence is lacking. This knowledge will help health care providers to optimize and improve patient care and recovery during the first time period after critically illness, by providing more tailored symptom management at the right time in future support strategies and future plans for rehabilitation.

The present study is a single-center study and has a prospective, longitudinal design. A set of different symptoms are measured in 170 former ICU patients the first week after ICU discharge, in addition to a set of cognitive, psychological, and physical symptoms and health state at hospital discharge. We will measure:

1. Totally 32 different symptoms on day 1; day 3; day 5; and day 7 after ICU discharge

2. A set of cognitive (assessing the level of cognitive function), psychological (posttraumatic stress, anxiety, depression), and physical symptoms (activities of daily life) and health status at hospital discharge. The same set of questionnaires will be filled in during ward stay reflecting patient situation one week prior to ICU admittance (used as baseline measures).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Nurses Organisation

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brita Fosser Olsen, RN,PhD

Role: PRINCIPAL_INVESTIGATOR

Østfold Hospital Trust Postbox 300, 1714 Grålum, Norway

Locations

Ostfold Hospital Trust

Sarpsborg, Gralum, Norway

Østfold Hospital Trust

Sarpsborg, Gralum, Norway

Countries

Norway

Other Identifiers

361816

Identifier Type: -

Identifier Source: org_study_id