Delirium Screening 3 Methods Study (DELIS-3)
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| ClinicalTrials.gov Identifier: NCT04551508 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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| Condition or disease |
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| Delirium Critical Illness |
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.
| 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 |
- 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.
- 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.
- 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.
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| 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 |
Inclusion Criteria:
- All patients admitted to critical care units.
Exclusion Criteria:
- Patients with RASS score of -3, -4, -5
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
| Contact: Anne H Nielsen, ph.d. | +45 60774422 | annsve@rm.dk | |
| Contact: Helle Svenningsen, ph.d. | +45 61660221 | hesv@via.dk |
| 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 | |
| Principal Investigator: | Helle Svenningsen, ph.d. | VIA University College, Aarhus, Denmark |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Delirium Critical Illness Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders Disease Attributes Pathologic Processes |