Clinical Evaluation Program of DeltaScan (Ward)
Primary Purpose
Delirium
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Spot monitoring device, excl. Sham
Sponsored by
About this trial
This is an interventional screening trial for Delirium focused on measuring Electroencephalography, Brain diseases, Confusion, Neurobehavioral Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- UMC Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control phase
Intervention phase
Arm Description
no intervention, i.e. care as usual
experimental intervention: spot monitoring device (excl. sham), i.e. use of DeltaScan
Outcomes
Primary Outcome Measures
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.
Length of admission (days)
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.
Secondary Outcome Measures
The time interval between admission (i.e. admission at the non-ICU departement) and the first delirium positive assessment
The number of delirium days
This outcomes is defined as the number of days with at least one positive assessment.
Delirium incidence
Hospital mortality
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.
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.
Number of days alive without delirium
Full Information
NCT ID
NCT03735927
First Posted
October 24, 2018
Last Updated
June 19, 2022
Sponsor
UMC Utrecht
Collaborators
Charite University, Berlin, Germany, KU Leuven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Prolira, Factory CRO, Implementation IQ, European Union
1. Study Identification
Unique Protocol Identification Number
NCT03735927
Brief Title
Clinical Evaluation Program of DeltaScan (Ward)
Official Title
DeltaScan for the Assessment of Delirium in the Ward: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 2).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
The pandemic caused a rising tide phenomenon on our primary outcomes 1) Delirium detection (increased by visit reduction & masked staff) and 2) Admission duration (increased by reorganizations & quarantines 'impact on being discharged)
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Charite University, Berlin, Germany, KU Leuven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Prolira, Factory CRO, Implementation IQ, European Union
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Electroencephalography, Brain diseases, Confusion, Neurobehavioral Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study hospital 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)
Allocation
Randomized
Enrollment
3907 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control phase
Arm Type
No Intervention
Arm Description
no intervention, i.e. care as usual
Arm Title
Intervention phase
Arm Type
Experimental
Arm Description
experimental intervention: spot monitoring device (excl. sham), i.e. use of DeltaScan
Intervention Type
Other
Intervention Name(s)
Spot monitoring device, excl. Sham
Intervention Description
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. 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'.
Primary Outcome Measure Information:
Title
Delirium detection rate
Description
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.
Time Frame
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
Title
Length of admission (days)
Description
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
The time interval between admission (i.e. admission at the non-ICU departement) and the first delirium positive assessment
Time Frame
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
Title
The number of delirium days
Description
This outcomes is defined as the number of days with at least one positive assessment.
Time Frame
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
Title
Delirium incidence
Time Frame
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
Title
Hospital mortality
Time Frame
From date of admission on the ward until date of death from any cause during hospitalization, assessed up to 12 months
Title
Direct medical costs of hospitalization
Description
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.
Time Frame
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
Title
Adherence to new delirium treatment protocol
Description
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.
Time Frame
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
Title
Number of days alive without delirium
Time Frame
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
Other Pre-specified Outcome Measures:
Title
Age
Time Frame
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
Title
Sex
Time Frame
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
Title
Type of admission, defined as acute or elective
Time Frame
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
Title
Reason for not using DeltaScan
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
Postbus 85500
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30579407
Citation
Numan T, van den Boogaard M, Kamper AM, Rood PJT, Peelen LM, Slooter AJC; Dutch Delirium Detection Study Group. Delirium detection using relative delta power based on 1-minute single-channel EEG: a multicentre study. Br J Anaesth. 2019 Jan;122(1):60-68. doi: 10.1016/j.bja.2018.08.021. Epub 2018 Oct 2.
Results Reference
background
PubMed Identifier
25166725
Citation
van der Kooi AW, Zaal IJ, Klijn FA, Koek HL, Meijer RC, Leijten FS, Slooter AJ. Delirium detection using EEG: what and how to measure. Chest. 2015 Jan;147(1):94-101. doi: 10.1378/chest.13-3050.
Results Reference
background
Learn more about this trial
Clinical Evaluation Program of DeltaScan (Ward)
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