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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05266118
Enrollment
177
Registered
2022-03-04
Start date
2022-04-19
Completion date
2023-03-02
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

None listed

Sponsors

Norwegian Nurses Organisation
CollaboratorOTHER
Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Multiple symptomsUp to 1 week after ICU dischargeMultiple 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.

Secondary

MeasureTime frameDescription
Posttraumatic stress symptomsAt hospital discharge, an average of one weekPosttraumatic stress symptoms is measured with Impact of event scale-revised (IES-R), a 22-item scale measuring the presence and severity of posttraumatic stress symptoms. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The total IES-R score range is 0-88; and higher score indicate higher symptom level.
Anxiety and depressionAt hospital discharge, an average of one weekAnxiety and depression is measured with Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, with seven each for measuring anxiety and depression. Each item can be scored on a scale from 0 (not at all) to 3 (very much). An overall score from 0 to 21 can be calculated for each subscale with the following score breakdown: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; and \> 11: Abnormal.
Cognitive symptomsAt hospital discharge, an average of one weekLevel of cognitive functioning is measured with The Mini Montreal Cognitive Assessment (Mini MoCA). Mini MoCA assess memory/attention; language; orientation; and delayed recall. The score can range from 0 to 15 points. Higher scores indicate better cognitive function, and 12 points or more is considered as normal.
Health statusAt hospital discharge, an average of one weekHealth status is measured with EQ-5D-5L. This tool assess walking, personal care, common chores, pain/ discomfort, and anxiety/ depression. Each item is rated on a 5 point Likert scale from 0 (no problem) to 5 (unable to or very strong symptoms). The total score can range from 0 to 25 points, and higher score indicates better health status.
Health-related quality of life stateAt hospital discharge, an average of one weekHealth-related quality of life state is measured with the visual analog scale of the EQ-5D-5L. The scale range from 0-100, with higher scores indicating better health status.
Physical symptomsAt hospital discharge, an average of one weekActivities of Daily Living is measured with Katz Index of Independence in Activities of Daily Living. Katz measures the patient's ability to perform personal activities of daily living; bathing, dressing, toileting, transferring, continence, and feeding. Each item are scored as independence (1 point) or dependence (0 point). The total score can range from 0 to 6 points; a score of 2 indicates severe functional impairment; a score of 4 indicates moderate function, and a score of 6 points indicates full physical function.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026