Clinical Evaluation Program of DeltaScan (ICU)

Study Overview
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Brief Summary
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Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Early detection of delirium would allow for early treatment and improved patient outcomes, but delirium is often not recognized and treatment is therefore delayed or not applied at all. Additionally, current screening tools are subjective, so an alternative, more objective diagnostic tool for early delirium detection is desired. The DeltaScan, a CE-certified device to detect delirium using brief EEG recording, has been recently been found have diagnostic properties that outperform the currently used screening tools. Objective: To quantify the impact of the use of the DeltaScan on patient outcome (detection rate of delirium and duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools. Study design: A prospective multicenter stepped wedge cluster randomized trials in (at least) 4 ICU departments. Study population: Adult patients admitted to an intensive care unit (ICU) with high risk of delirium. Intervention: During 12 months, patients presenting at the ICU of participating hospitals with an expected stay > 1 day will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. the Confusion Assessment Method (CAM)-ICU) or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 2 months, starting at day 0, randomly allocated hospitals will sequentially start to apply the DeltaScan in all eligible patients (intervention period). During the last 3 months of the study all hospitals will participate in the intervention period. Main study endpoints: Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at ICU. Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the intervention period EEG recordings using the CE-certified DeltaScan will be made using a strip with EEG electrodes that will be mounted to the head using self-adhesive gel. The EEG recording will be performed two to three times daily and takes 3-4 minutes. During the usual care period the patients will receive the standard delirium screening tool for delirium assessment by a nurse. This assessment will be performed two to three times daily and takes 2-4 minutes depending on the screening tools that is used. Since the DeltaScan has shown to have superior diagnostic performance compared to the DSM5 the burden/risk of misclassification is lower than with the current standard for delirium assessment. Based on the above we consider the burden to participants in this study to be minimal.

Official Title
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DeltaScan for the Assessment of Delirium in the Intensive Care: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 1)

Conditions
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Delirium

Intervention / Treatment
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* Other: Spot monitoring device, excl. Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the ICU department At risk of delirium, defined according to local protocol: ICU patients: when expected stay is > 1 day Exclusion Criteria: Age younger than 18 years. Admitted because of a primary neurological or neurosurgical disease. Patients who cannot clinically assessed for delirium, e.g. due to a language barrier or deafness. Known pre-existing dementia. We decided to add an extra exclusion criteria: Patients infected with SARS-CoV-19 infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study ICU departments will be randomized with respect to the time they will introduce the DeltaScan following a stepped wedge cluster randomization design. All departments apply 'usual care' in combination with a harmonized delirium treatment protocol during the control phase. After this first time period, each new time period a department switches to the intervention period. Due to the first wave of the COVID-19 pandemic the stepped wedge planning was interrupted. Where possible the control period and/or intervention, whichever was affected, will be extended. We marked the first wave of the COVID-19 pandemic from the 15th of March until the 15th of May or longer for a few heavily effected sites with a maximum of 6 months. Data collected during this period will not be used for primary analysis, but may be used for specific sub analyses.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control phase<br>no intervention, i.e. care as usual | |
| Experimental: Intervention phase<br>experimental intervention: spot monitoring device, i.e. use of DeltaScan | Other: Spot monitoring device, excl. Sham<br>* o During the control phase the 'care as usual' regarding delirium screening is studied. During the intervention phase the DeltaScan will be studied as screening method for delirium. o During the intervention phase the DeltaScan will be used on the exact same moments, i.e. same time and same amount of measures per day, as the screening methods used in the 'care as usual'.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium detection rate | The detection rate of delirium will be defined as the proportion of delirium positive assessments during conditions that a patient can be assessed for delirium. A positive delirium assessment in the usual care period will be defined as a positive score on the delirium detection tool that is currently used in the participating department according to the protocol of that department. A positive delirium assessment in the intervention period will be defined as a DeltaScan score of 4 or 5. | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| Length of admission (days) | The duration of admission will be defined as the cumulative duration of ICU admission. The criteria for discharge will be the same in the usual care period and the intervention period. | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time interval between admission (i.e. ICU admission) and the first delirium positive assessment |  | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| The number of delirium days | This outcomes is defined as the number of days with at least one positive assessment. | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| Delirium incidence |  | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| Hospital mortality |  | From date of admission on the ICU until date of death from any cause, assessed up to 12 months | 
| Direct medical costs of hospitalization | We aim to collect health care consumption in detail for every included patient. This health care consumption for instance consists of number of hospitalization days, medication, diagnostic procedures. These data will be extracted from the hospital systems. General reference prices (open source, National Tariffs) will be applied to this health care consumption to calculate total costs. | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| Adherence to new delirium treatment protocol | Steps that are taken (e.g. pharmacological or non-pharmacological treatment, consults of specialist etc.) by the hospital staff after a delirium screener gives a delirium positive score. | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| Duration of mechanical ventilation |  | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 
| Hospital length of stay |  | From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months | 
| Incidence of ICU re-admission |  | From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months | 
| Number of days alive without delirium and without coma (i.e. RASS -3, -4 or -5) in 28 days |  | From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroencephalography, Intensive Care, Brain disease, Confusion, Neurobehavioral Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders