Altered Level of ConsciousnessNCT03040843
Documentation of Altered Mental Status
An observational study of Altered Level of Consciousness, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
Trial summary
Altered mental status (AMS) is common in older patients. However there is a lack of standardization in the definition and documentation of this compliant. Different perception of AMS can cause negative impact on interpretation and obtaining scientific data. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Altered Level of Consciousness
- How many people
- 1,200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Jun 2017
- 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All older emergency department patients aged 65 and older.
Who may be able to join
- All older ED patients
Who cannot join
- Unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (STE MI, severe dyspnea, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Altered mental status (AMS) is common in older patients. However there is a lack of standardization in the definition and documentation of this compliant. Different perception of AMS can cause negative impact on interpretation and obtaining scientific data. Although definition of AMS is so complicated, clinical documentation can be detected in these patients with AMS.
Read the detailed description
Basically, consciousness is the state of full awareness of the self and one's relationship to the environment. There are 2 related areas of neurologic function that are connected to consciousness: content (orientation and memory) and level (arousal and response to stimuli).
The mental changes are best looked for in terms of arousal, attention, alertness, orientation, cognition, memory, affect, and perception. Arousal (level of consciousness) can be detected by the Richmond Agitation and Sedation Scale. Others are related to content of consciousness and can be evaluated by cognitive tests. After one month pilot study, the investigators chose 5 features of content of consciousness due to easy applicable and detectable;
- Attention (counting numbers backwards from 20) (>1 error positive)
- Cognition (disorganized thinking; meaningless speech, irrelevant explanations)
- Perception (visual or auditory hallucinations)
- Memory (3 items recall) (>1 error positive)
- Orientation (day of week, month and year) (>1 error positive)
These features are also combination of six item screener test and delirium symptoms.
All elderly patients (65 aged and older) presented to the emergency department, will be assessed according to these two methods; content and level of consciousness. And also, every patient's baseline status of consciousness will be obtained from surrogates who knows the patient best. All changes from patient's baseline status will be recorded. The investigators will investigate how changes are reflected in the clinic.
- Conditions
- Altered Level of Consciousness
- Keywords
- documentation, altered mental status, definition, clinically
- Medical subject headings
- Consciousness Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of impaired level of consciousness in older ED patients
Arousal (level of consciousness) measured by the Richmond Agitation and Sedation Scale.
Measured: First 30 minute of presentation to the emergency department
Detection of impaired content of consciousness in older ED patients
Awareness (content of consciousness) measured by the 5 criteria list questionnaire.
Measured: First 30 minute of presentation to the emergency department
Secondary outcomes (1)
Mortality
Measured: 1 and 3 month mortality after patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Altered Level of ConsciousnessStudies 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
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Public Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Ali Aslaner, Nevsehir Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040843
- Sponsor's protocol ID
- NevsehirPH
- Status last verified
- Sep 2017
- First submitted
- 25 Dec 2016
- Last updated
- 21 Sep 2017
- Results posted
- No
Publications
Aslaner MA, Boz M, Celik A, Ahmedali A, Eroglu S, Metin Aksu N, Eroglu SE. Etiologies and delirium rates of elderly ED patients with acutely altered mental status: a multicenter prospective study. Am J Emerg Med. 2017 Jan;35(1):71-76. doi: 10.1016/j.ajem.2016.10.004. Epub 2016 Oct 5.
PubMed 27765479Han JH, Wilber ST. Altered mental status in older patients in the emergency department. Clin Geriatr Med. 2013 Feb;29(1):101-36. doi: 10.1016/j.cger.2012.09.005.
PubMed 23177603European Delirium Association; American Delirium Society. The DSM-5 criteria, level of arousal and delirium diagnosis: inclusiveness is safer. BMC Med. 2014 Oct 8;12:141. doi: 10.1186/s12916-014-0141-2.
PubMed 25300023
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Altered Mental Status
- ClinicalTrials.gov ID
- NCT03040843
- Acronym / sponsor ID
- NevsehirPH
- Conditions
- Altered Level of Consciousness
- Keywords
- documentation, altered mental status, definition, clinically
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Nevsehir Public HospitalOther government
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017
- First posted
- 2 Feb 2017 (estimated)
- 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.
Altered mental status (AMS) is common in older patients. However there is a lack of standardization in the definition and documentation of this compliant. Different perception of AMS can cause negative impact on interpretation and obtaining scientific data. Although definition of AMS is so complicated, clinical documentation can be detected in these patients with AMS.
Detailed description
Basically, consciousness is the state of full awareness of the self and one's relationship to the environment. There are 2 related areas of neurologic function that are connected to consciousness: content (orientation and memory) and level (arousal and response to stimuli).
The mental changes are best looked for in terms of arousal, attention, alertness, orientation, cognition, memory, affect, and perception. Arousal (level of consciousness) can be detected by the Richmond Agitation and Sedation Scale. Others are related to content of consciousness and can be evaluated by cognitive tests. After one month pilot study, the investigators chose 5 features of content of consciousness due to easy applicable and detectable;
- Attention (counting numbers backwards from 20) (>1 error positive)
- Cognition (disorganized thinking; meaningless speech, irrelevant explanations)
- Perception (visual or auditory hallucinations)
- Memory (3 items recall) (>1 error positive)
- Orientation (day of week, month and year) (>1 error positive)
These features are also combination of six item screener test and delirium symptoms.
All elderly patients (65 aged and older) presented to the emergency department, will be assessed according to these two methods; content and level of consciousness. And also, every patient's baseline status of consciousness will be obtained from surrogates who knows the patient best. All changes from patient's baseline status will be recorded. The investigators will investigate how changes are reflected in the clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All older emergency department patients aged 65 and older.
Key inclusion criteria (1 listed)
- All older ED patients
Key exclusion criteria (1 listed)
- Unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (STE MI, severe dyspnea, etc)
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
Detection of impaired level of consciousness in older ED patients
Time frame: First 30 minute of presentation to the emergency department
Arousal (level of consciousness) measured by the Richmond Agitation and Sedation Scale.
Detection of impaired content of consciousness in older ED patients
Time frame: First 30 minute of presentation to the emergency department
Awareness (content of consciousness) measured by the 5 criteria list questionnaire.
1 secondary outcome
Mortality
Time frame: 1 and 3 month mortality after patient enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Background: PubMed 27765479Aslaner MA, Boz M, Celik A, Ahmedali A, Eroglu S, Metin Aksu N, Eroglu SE. Etiologies and delirium rates of elderly ED patients with acutely altered mental status: a multicenter prospective study. Am J Emerg Med. 2017 Jan;35(1):71-76. doi: 10.1016/j.ajem.2016.10.004. Epub 2016 Oct 5.
- Background: PubMed 23177603Han JH, Wilber ST. Altered mental status in older patients in the emergency department. Clin Geriatr Med. 2013 Feb;29(1):101-36. doi: 10.1016/j.cger.2012.09.005.
- Background: PubMed 25300023European Delirium Association; American Delirium Society. The DSM-5 criteria, level of arousal and delirium diagnosis: inclusiveness is safer. BMC Med. 2014 Oct 8;12:141. doi: 10.1186/s12916-014-0141-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Altered Level of Consciousness, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 21 Sep 2017. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of impaired level of consciousness in older ED patients (time frame: First 30 minute of presentation to the emergency department). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040843, which also lists 3 linked publications.
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 21 Sep 2017.