Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Delirium Screening 3 Methods Study (DELIS-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551508
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Højager Nielsen, Hospitalsenheden Vest

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

Condition or disease
Delirium Critical Illness

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Confusion Assessment Method of the Intensive Care Unit (CAM-ICU) [ Time Frame: Day 1 ]
    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU can be either positive (indicating delirium) or negative.

  2. Confusion assessment method of the intensive care unit 7 (CAM-ICU -7) [ Time Frame: Day 1 ]
    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.

  3. intensive care delirium screening checklist (ICDSC) [ Time Frame: Day 1 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients admitted to critical care units may be included in this study.
Criteria

Inclusion Criteria:

  • All patients admitted to critical care units.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551508


Contacts
Layout table for location contacts
Contact: Anne H Nielsen, ph.d. +45 60774422 annsve@rm.dk
Contact: Helle Svenningsen, ph.d. +45 61660221 hesv@via.dk

Locations
Layout table for location information
Denmark
Odense Universitetshospital Recruiting
Odense, C, Denmark, 5000
Contact: Eva Lærkner, ph.d.         
Regionshospitalet Herning Not yet recruiting
Herning, Region Midtjylland, Denmark, 7400
Contact: Anne H Nielsen, RN, MCN    +45 6077442    annsve@rm.dk   
Regionshospitalet Holstebro Not yet recruiting
Holstebro, Region Midtjylland, Denmark, 7500
Contact: Anne H Nielsen, RN, Ph.D.    +45 60774422    annsve@rm.dk   
Aalborg Universitetshospital Recruiting
Aalborg, Denmark, 9000
Contact: Maria P Søndergaard, RN         
Aarhus Universitetshospital Recruiting
Aarhus, Denmark, 8200
Contact: Linette Thorn, RN         
Rigshospitalet Recruiting
Copenhagen Ø, Denmark, 2100
Contact: Marie O Collet, ph.d.         
Sydvestjysk sygehus Recruiting
Esbjerg, Denmark, 6700
Contact: Susanne Fischer, RN         
Nordsjællands Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Louise S Hvid, RN         
Holbæk Sygehus Recruiting
Holbæk, Denmark, 4300
Contact: Janet Froulund, ph.d.         
Regionshospitalet Horsens Recruiting
Horsens, Denmark, 8700
Contact: Edel Laursen, RN         
Sjællands Universitetshospital Recruiting
Køge, Denmark, 4600
Contact: Camilla Bekker, ph.d.         
Regionshospitalet Randers Recruiting
Randers, Denmark, 8930
Contact: Marianne Villumsen, RN         
Vejle Sygehus Recruiting
Vejle, Denmark, 7100
Contact: Sabrina S Jensen, RN         
Regionshospitalet Viborg Recruiting
Viborg, Denmark, 8800
Contact: Tina A Nielsen, RN         
Sponsors and Collaborators
Hospitalsenheden Vest
Investigators
Layout table for investigator information
Principal Investigator: Helle Svenningsen, ph.d. VIA University College, Aarhus, Denmark
Publications:
Layout table for additonal information
Responsible Party: Anne Højager Nielsen, Principal Investigator, MCN, PH.D., Hospitalsenheden Vest
ClinicalTrials.gov Identifier: NCT04551508    
Other Study ID Numbers: 31-1521-440 (STPS)
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Critical Illness
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes