Delirium Screening 3 Methods Study

NCT ID: NCT04551508

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2021-11-01

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.

Conditions

Delirium; Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All patients admitted to critical care units.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitalsenheden Vest

OTHER

Sponsor Role: lead

Responsible Party

Anne Højager Nielsen

Principal Investigator, MCN, PH.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helle Svenningsen, ph.d.

Role: PRINCIPAL_INVESTIGATOR

VIA University College, Aarhus, Denmark

Locations

Regionshospitalet Herning

Herning, Central Jutland, Denmark

Regionshospitalet Holstebro

Holstebro, Central Jutland, Denmark

Odense Universitetshospital

Odense, C, Denmark

Aalborg Universitetshospital

Aalborg, , Denmark

Aarhus Universitetshospital

Aarhus, , Denmark

Rigshospitalet

Copenhagen Ø, , Denmark

Sydvestjysk sygehus

Esbjerg, , Denmark

Nordsjællands Hospital

Hillerød, , Denmark

Holbæk Sygehus

Holbæk, , Denmark

Regionshospitalet Horsens

Horsens, , Denmark

Sjællands Universitetshospital

Køge, , Denmark

Regionshospitalet Randers

Randers, , Denmark

Vejle Sygehus

Vejle, , Denmark

Regionshospitalet Viborg

Viborg, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 28263192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11430542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11445689 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20002362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31273763 (View on PubMed)

Other Identifiers

31-1521-440 (STPS)

Identifier Type: -

Identifier Source: org_study_id