Delirium Screening 3 Methods Study

Critical Illness Clinical Trial

— DELIS-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551508
• Other study ID #: 31-1521-440 (STPS)
• Status: Completed
• Start date: September 9, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2022
• Source: Hospitalsenheden Vest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1126
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted to critical care units.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Rigshospitalet	Copenhagen Ø
Denmark	Sydvestjysk sygehus	Esbjerg
Denmark	Regionshospitalet Herning	Herning	Region Midtjylland
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Holbæk Sygehus	Holbæk
Denmark	Regionshospitalet Holstebro	Holstebro	Region Midtjylland
Denmark	Regionshospitalet Horsens	Horsens
Denmark	Sjællands Universitetshospital	Køge
Denmark	Odense Universitetshospital	Odense	C
Denmark	Regionshospitalet Randers	Randers
Denmark	Vejle Sygehus	Vejle
Denmark	Regionshospitalet Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Hospitalsenheden Vest

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Granholm A, Perner A, Krag M, Marker S, Hjortrup PB, Haase N, Holst LB, Collet MO, Jensen AKG, Møller 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1