Clinical trial NCT05266118: Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge
Official title: Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptoms and Signs
Symptom Cluster
Follow-up Care
Critical Illness
Keywords: Critical ill
PICS
Ward
Follow-up care
Symptoms and Signs
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Norwegian Nurses Organisation
First posted: 2022-03-04
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: Inclusion criteria: Participants is former ICU patients over 18 years, 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

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

Primary outcomes:
measure: Multiple symptoms
timeFrame: Up to 1 week after ICU discharge
Secondary outcomes:
measure: Cognitive symptoms
timeFrame: At hospital discharge, an average of one week
measure: Posttraumatic stress symptoms
timeFrame: At hospital discharge, an average of one week
measure: Anxiety and depression
timeFrame: At hospital discharge, an average of one week
measure: Physical symptoms
timeFrame: At hospital discharge, an average of one week
measure: Health status
timeFrame: At hospital discharge, an average of one week
measure: Health-related quality of life state
timeFrame: At hospital discharge, an average of one week
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Ostfold Hospital Trust
state: Gralum
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
state: Gralum
Study officials:
affiliation: Østfold Hospital Trust Postbox 300, 1714 Grålum, Norway
name: Brita Fosser Olsen, RN,PhD
role: PRINCIPAL_INVESTIGATOR
References: