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Documentation of Altered Mental Status

NCT ID: NCT03040843

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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;

1. Attention (counting numbers backwards from 20) (\>1 error positive)
2. Cognition (disorganized thinking; meaningless speech, irrelevant explanations)
3. Perception (visual or auditory hallucinations)
4. Memory (3 items recall) (\>1 error positive)
5. 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

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Altered Level of Consciousness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All older ED patients

Exclusion Criteria

* Unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (STE MI, severe dyspnea, etc)
Minimum Eligible Age

65 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nevsehir Public Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Ali Aslaner

Attending Emergency Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nevsehir State Hospital

Nevşehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27765479 (View on PubMed)

Han 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.

Reference Type BACKGROUND
PMID: 23177603 (View on PubMed)

European 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.

Reference Type BACKGROUND
PMID: 25300023 (View on PubMed)

Other Identifiers

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NevsehirPH

Identifier Type: -

Identifier Source: org_study_id