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Delirium Detection During Routine Patient Care

Validation of a Viable Delirium Detection Test Performed by Nurses and Physicians During Routine Patient Care

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05836714
Enrollment
365
Registered
2023-05-01
Start date
2023-05-01
Completion date
2024-05-31
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

DELIRIUM, DIAGNOSIS, 4AT

Brief summary

Despite the presence of validated tests, there are still drawbacks to implementing delirium diagnosis tests in hospital wards. We developed a new, simple, easy to implement user friendly delirium diagnostic test that is likely to facilitate implementation in many departments. The present study will compare the new test to a well validated older test - 4AT.

Detailed description

Delirium is characterized by an acute onset altered mental status and/or a confusional state. Although delirium has been known since ancient times, the condition is often not diagnosed, documented, evaluated, and managed. Early detection of delirium in hospitalized patients may be critical, particularly on internal medicine wards, as mental deterioration in the elderly can be the first sign of preventable diseases and disorders that precipitate delirium. Nevertheless only 15%-35% of cases of delirium in hospitalized patients are identified by the treating staff and documented in the medical records. The main reasons for this shortcoming are insufficient awareness to emerging delirium, and excessive work load. We have recently developed and implemented in our Department of Internal Medicine a new diagnostic tool for delirium. This test, designated R&M, is based on a combination of RADAR (Recognizing Acute Delirium As part of your Routine), performed by the nurses during medication dispensing, and MOYB (Months Of the Year Backwards), performed by residents during the routine rounds in patients with positive RADAR. Both tests are online and saved in the patients' electronic records. The purpose of this study is to demonstrate non-inferiority of R&M compared to 4AT (Attention, Abbreviated mental test, Alertness, Acute onset Test), an old and well validated delirium recognition test. The sample size required for a sensitivity of 95% and a 95% confidence interval was calculated to be n=365, assuming delirium prevalence of \>20% in elderly patients hospitalized in internal medicine wards.

Interventions

None listed

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- patients \>70 yrs old, hospitalized in the department of internal medicine

Exclusion criteria

* severe dementia

Design outcomes

Primary

MeasureTime frameDescription
Validation of a viable delirium detection test care.ONE YEARnon-inferiority of a new delirium detection test (R&M) compared to 4AT.

Countries

Israel

Contacts

Primary ContactRON OLIVEN, MD
RON.OLIVEN@B-ZION.ORG.IL972-506268303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026