Clinical Evaluation Program of DeltaScan (Ward)
- Conditions
- Delirium
- Interventions
- Other: Spot monitoring device, excl. Sham
- Registration Number
- NCT03735927
- Lead Sponsor
- UMC Utrecht
- Brief Summary
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) 6 non-ICU departments.
Study population: Elderly admitted to non-ICU departments with high risk of delirium.
Intervention: During 12 months, frail elderly admitted to a non-ICU department of participating hospitals with high risk of delirium will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. Delirium Observation Screening (DOS) 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 5 weeks, 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 the non-ICU department. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3907
- Admitted to the non-ICU hospital department, defined as a cardio thoracic surgery or geriatric traumatology
- At risk of delirium, defined according to local protocol:
A. Frail elderly, defined according to local protocol B. That underwent surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention phase Spot monitoring device, excl. Sham experimental intervention: spot monitoring device (excl. sham), i.e. use of DeltaScan
- Primary Outcome Measures
Name Time Method Length of admission (days) From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months The duration of admission will be defined as the length of stay in the non-ICU hospital department (in case of intermediate ICU admission: the cumulative duration of stay in the non-ICU department that participates in this study). The criteria for discharge will be the same in the usual care period and the intervention period.
Delirium detection rate From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Hospital mortality From date of admission on the ward until date of death from any cause during hospitalization, assessed up to 12 months Direct medical costs of hospitalization From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months 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.
Adherence to new delirium treatment protocol From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months 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.
The time interval between admission (i.e. admission at the non-ICU departement) and the first delirium positive assessment From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months Delirium incidence From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months The number of delirium days From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months This outcomes is defined as the number of days with at least one positive assessment.
Number of days alive without delirium From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months
Trial Locations
- Locations (1)
UMC Utrecht
🇳🇱Utrecht, Netherlands