Clinical Evaluation Program of DeltaScan (Ward)

June 19, 2022 updated by: A.J.C. Slooter, UMC Utrecht

DeltaScan for the Assessment of Delirium in the Ward: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 2).

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3907

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, Postbus 85500
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
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
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
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
Time Frame: From date of admission on the ward until date of death from any cause during hospitalization, assessed up to 12 months
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
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.
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
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.
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
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
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

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTI-820555-DeltaScan-study2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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