Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-18 @ 9:58 AM
Study NCT ID:
NCT05836714
Status:
None
Last Update Posted:
2023-05-01 00:00:00
First Post:
2023-04-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delirium Detection During Routine Patient Care
Sponsor:
None
Organization:
Study Overview
Official Title:
Validation of a Viable Delirium Detection Test Performed by Nurses and Physicians During Routine Patient Care
Status:
None
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: