DeliriumNCT05836714
Delirium Detection During Routine Patient Care
An observational study of Delirium, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium
- How many people
- 365 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients >70 yrs old, hospitalized in the department of internal medicine
Who may be able to join
- patients >70 yrs old, hospitalized in the department of internal medicine
Who cannot join
- severe dementia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai-Zion Medical Center
Haifa
RON OLIVEN, MD, 972-506268303, ron.oliven@b-zion.org.il
About this study
Official title: Validation of a Viable Delirium Detection Test Performed by Nurses and Physicians During Routine Patient Care
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.
Read the 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.
- Conditions
- Delirium
- Keywords
- DELIRIUM, DIAGNOSIS, 4AT
- Medical subject headings
- Delirium, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a viable delirium detection test care.
non-inferiority of a new delirium detection test (R\&M) compared to 4AT.
Measured: ONE YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- RON OLIVEN, MD, Principal investigator, BNAI-ZION MC HAIFA ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836714
- Sponsor's protocol ID
- 0094-18-BNZ
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Viable Delirium Detection Test Performed by Nurses and Physicians During Routine Patient Care
- ClinicalTrials.gov ID
- NCT05836714
- Acronym / sponsor ID
- 0094-18-BNZ
- Conditions
- Delirium
- Keywords
- DELIRIUM, DIAGNOSIS, 4AT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients >70 yrs old, hospitalized in the department of internal medicine
Key inclusion criteria (1 listed)
- patients >70 yrs old, hospitalized in the department of internal medicine
Key exclusion criteria (1 listed)
- severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RON OLIVEN, MD principal investigator
BNAI-ZION MC HAIFA ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RON OLIVEN, MD (972-506268303, RON.OLIVEN@B-ZION.ORG.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a viable delirium detection test care. (time frame: ONE YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.