Clinical Evaluation Program of DeltaScan (Ward)

NCT03735927 | Terminated

• 1 other identifier: FTI-820555-DeltaScan-study2
• Study Type: interventional
• Target: 3,907
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Electroencephalography; Brain diseases; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (2)

• 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 ward until date of discharge from the ward 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 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.

  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 Outcomes (7)

• 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

• 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

• 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

• 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

Other Outcomes (4)

• Age

  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

• Sex

  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

• Type of admission, defined as acute or elective

  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

Study Arms (2)

Control phase

NO INTERVENTION

no intervention, i.e. care as usual

Intervention phase

EXPERIMENTAL

experimental intervention: spot monitoring device (excl. sham), i.e. use of DeltaScan

Other: Spot monitoring device, excl. Sham

Interventions

Spot monitoring device, excl. Sham OTHER

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'.

Intervention phase

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Charite University, Berlin, Germany: collaborator
• KU Leuven: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Prolira: collaborator
• Factory CRO: collaborator
• Implementation IQ: collaborator
• European Union: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Postbus 85500, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 30579407 BACKGROUND

• 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.

  PMID: 25166725 BACKGROUND

MeSH Terms

Conditions

Delirium; Brain Diseases; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Neuropsychiatry

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 29, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)