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Clinical Evaluation Program of DeltaScan (Ward)

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ClinicalTrials.gov Identifier: NCT03735927
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborators:
Charite University, Berlin, Germany
KU Leuven
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prolira
Factory CRO
Implementation IQ
European Union
Information provided by (Responsible Party):
A.J.C. Slooter, 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.


Condition or disease Intervention/treatment Phase
Delirium Other: Spot monitoring device, excl. Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.

This design has a number of advantages. It is especially appropriate when the intervention encompasses the implementation of a change in logistics, procedures, or information use, which is the case in our trial comparing two diagnostic strategies in patients at risk of delirium (usual care delirium screening and the introduction of the DeltaScan). Furthermore, it allows adjusting the implementation to the local setting in each participating hospital. This ensures that the study design more closely resembles daily clinical practice, resulting in realistic effect estimates conform daily practice.

Masking: None (Open Label)
Primary Purpose: Screening
Official Title: DeltaScan for the Assessment of Delirium in the Ward: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 2).
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
No Intervention: Control phase
no intervention, i.e. care as usual
Experimental: Intervention phase
experimental intervention: spot monitoring device (excl. sham), i.e. use of DeltaScan
Other: Spot monitoring device, excl. Sham
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 Measures :
  1. Delirium detection rate [ 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 ]
    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.

  2. Length of admission (days) [ 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 ]
    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 :
  1. 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 ]
  2. The number of delirium days [ 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 ]
    This outcomes is defined as the number of days with at least one positive assessment.

  3. 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 ]
  4. 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 ]
  5. Direct medical costs of hospitalization [ 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 ]
    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.

  6. Adherence to new delirium treatment protocol [ 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 ]
    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.

  7. 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 Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735927


Contacts
Contact: Arjen JC Slooter, MD, PhD 0031 88 75 596 77 A.Slooter-3@umcutrecht.nl
Contact: Simone JT van Montfort, MSc 0031 88 75 578 38 s.j.t.vanmontfort-2@umcutrecht.nl

Sponsors and Collaborators
UMC Utrecht
Charite University, Berlin, Germany
KU Leuven
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prolira
Factory CRO
Implementation IQ
European Union

Publications:
Responsible Party: A.J.C. Slooter, Professor of Intensive Care Neuropsychiatry, UMC Utrecht
ClinicalTrials.gov Identifier: NCT03735927     History of Changes
Other Study ID Numbers: FTI-820555-DeltaScan-study2
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A.J.C. Slooter, UMC Utrecht:
Electroencephalography
Brain diseases
Confusion
Neurobehavioral Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders