Clinical trial NCT04551508: Delirium Screening 3 Methods 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Critical Illness
Lead sponsor: Hospitalsenheden Vest
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 1126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted to critical care units may be included in this study.

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

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.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to critical care units.

Exclusion Criteria:

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

Primary outcomes:
measure: Confusion Assessment Method of the Intensive Care Unit (CAM-ICU)
timeFrame: Day 1
measure: Confusion assessment method of the intensive care unit 7 (CAM-ICU -7)
timeFrame: Day 1
measure: intensive care delirium screening checklist (ICDSC)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: C
city: Herning
country: Denmark
facility: Regionshospitalet Herning
state: Region Midtjylland
city: Holstebro
country: Denmark
facility: Regionshospitalet Holstebro
state: Region Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet
city: Esbjerg
country: Denmark
facility: Sydvestjysk sygehus
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Horsens
country: Denmark
facility: Regionshospitalet Horsens
city: Køge
country: Denmark
facility: Sjællands Universitetshospital
city: Randers
country: Denmark
facility: Regionshospitalet Randers
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg
Study officials:
affiliation: VIA University College, Aarhus, Denmark
name: Helle Svenningsen, ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1007/s001340100909.
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. doi: 10.1097/00003246-200107000-00012.
citation: 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.
citation: 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.