Delirium Detection During Routine Patient Care

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836714
• Other study ID #: 0094-18-BNZ
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: Bnai Zion Medical Center
• Contact: RON OLIVEN, MD
• Phone: 972-506268303
• Email: RON.OLIVEN[@]B-ZION.ORG.IL
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 365
• Est. completion date: May 31, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• severe dementia

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Israel	Bnai-Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of a viable delirium detection test care.	non-inferiority of a new delirium detection test (R&M) compared to 4AT.	ONE YEAR