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DeliriumDELIS-3NCT04551508

Delirium Screening 3 Methods Study

An observational study of Delirium and Critical Illness, run by Hospitalsenheden Vest at 14 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Observational study comparing three different methods of delirium detection in critically ill patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium, Critical Illness
How many people
1,126 participants
Where
14 sitesDenmark
Study dates
9 Sep 2020to 1 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients admitted to critical care units may be included in this study.

Who may be able to join

  • All patients admitted to critical care units.

Who cannot join

  • Patients with RASS score of -3, -4, -5

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Denmark14 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus Universitetshospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen Ø, 2100

  • Sydvestjysk sygehus

    Esbjerg, 6700

  • Regionshospitalet Herning

    Herning, Central Jutland, 7400

  • Nordsjællands Hospital

    Hillerød, 3400

  • Holbæk Sygehus

    Holbæk, 4300

  • Regionshospitalet Holstebro

    Holstebro, Central Jutland, 7500

  • Regionshospitalet Horsens

    Horsens, 8700

  • Sjællands Universitetshospital

    Køge, 4600

  • Odense Universitetshospital

    Odense, C, 5000

  • Regionshospitalet Randers

    Randers, 8930

  • Vejle Sygehus

    Vejle, 7100

  • Regionshospitalet Viborg

    Viborg, 8800

Other trials in Denmark

About this study

Official title: Delirium Screening 3 Methods Study (DELIS-3). Agreement Between CAM-ICU, CAM-ICU-7 and ICDSC in a Danish Population of ICU Patients and Nurses' Perception of the Clinical Relevance of Delirium Screening

Observational study comparing three different methods of delirium detection in critically ill patients.

Read the detailed description

The DELIS-3 study aims to compare three different approaches to detection of ICU (intensive care unit) delirium in critically ill patients. The CAM-ICU (Confusion Assessment Method for the ICU) and the ICDSC (Intensive Care Delirium Screening Checklist) have both been developed in the early 1990. The CAM-ICU is either positive or negative, whereas the ICDSC is a score between 0-8. A score above 3 is delirium positive. Neither scale has been validated as severity scales. The novel CAM-ICU-7 is developed from the original CAM-ICU and has been validated as a severity scale.

Detection of delirium in critically ill patients is highly necessary as delirium can be very painful to the patient. Moreover, certain subtypes of delirium is associated with increased mortality and poorer cognitive outcome when patients are followed up on long term.

Therefore, delirium screening of all patients is standard care in most intensive care units.

However, there is also a need to assess severity of delirium. The recently published CAM-ICU-7 has now been translated to Danish and this study will explore its performance compared to the CAM-ICU and the ICDSC.

In 17 Danish ICU's 10 nurses will be trained in using all three instruments. Each nurse will subsequently screen 10 patients each with all three instruments as part of their normal practice. The sequence of the instruments will be randomized to avoid that one instrument is favored by always being used first, second or last.

For each patient the following data will be collected: sex, age, reason for hospitalization (medical, neurological, surgical/ acute, planned), ventilator treatment, ability to verbalize, RASS score (sedation and agitation score) severity of disease (SMS score) and time of admission.

After all screenings has been collected, nurses will fill in a questionnaire on their perceptions of each scales' ability to reliably detect delirium, userfriendliness and how time consuming each scale were to use.

Medical subject headings
Delirium, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confusion Assessment Method of the Intensive Care Unit (CAM-ICU)

    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU can be either positive (indicating delirium) or negative.

    Measured: Day 1

  2. Confusion assessment method of the intensive care unit 7 (CAM-ICU -7)

    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU-7 can yield a score of 0-7 points, higher values indicative of worse delirium.

    Measured: Day 1

  3. intensive care delirium screening checklist (ICDSC)

    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. ICDSC can yield a score of 0-8 points, higher values indicative of worse delirium.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start9 Sep 2020
  3. Primary completion1 Nov 2021
  4. Study completion1 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551508
Sponsor's protocol ID
31-1521-440 (STPS)
Acronym
DELIS-3
Status last verified
Mar 2022
First submitted
9 Sep 2020
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.

    PubMed 28263192

  • Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.

    PubMed 11430542

  • Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.

    PubMed 11445689

  • Almgren M, Lundmark M, Samuelson K. The Richmond Agitation-Sedation Scale: translation and reliability testing in a Swedish intensive care unit. Acta Anaesthesiol Scand. 2010 Jul;54(6):729-35. doi: 10.1111/j.1399-6576.2009.02173.x. Epub 2009 Dec 5.

    PubMed 20002362

  • Granholm A, Perner A, Krag M, Marker S, Hjortrup PB, Haase N, Holst LB, Collet MO, Jensen AKG, Moller MH. External validation of the Simplified Mortality Score for the Intensive Care Unit (SMS-ICU). Acta Anaesthesiol Scand. 2019 Oct;63(9):1216-1224. doi: 10.1111/aas.13422. Epub 2019 Jul 4.

    PubMed 31273763

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium and Critical Illness, run by Hospitalsenheden Vest at 14 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confusion Assessment Method of the Intensive Care Unit (CAM-ICU) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551508, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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