- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05836714
Delirium Detection During Routine Patient Care
Validation of a Viable Delirium Detection Test Performed by Nurses and Physicians During Routine Patient Care
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: RON OLIVEN, MD
- Phone Number: 972-506268303
- Email: ron.oliven@b-zion.org.il
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Bnai-Zion Medical Center
-
Contact:
- RON OLIVEN, MD
- Phone Number: 972-506268303
- Email: ron.oliven@b-zion.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients >70 yrs old, hospitalized in the department of internal medicine
Exclusion Criteria:
- severe dementia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of a viable delirium detection test care.
Time Frame: ONE YEAR
|
non-inferiority of a new delirium detection test (R&M) compared to 4AT.
|
ONE YEAR
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RON OLIVEN, MD, BNAI-ZION MC HAIFA ISRAEL
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0094-18-BNZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicCompletedDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland