Clinical trial NCT03040843: Documentation of Altered Mental Status
Official title: Documentation of Altered Mental Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Altered Level of Consciousness
Keywords: documentation
altered mental status
definition
clinically
Lead sponsor: Nevsehir Public Hospital
Sponsor class: OTHER_GOV
First posted: 2017-02-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All older emergency department patients aged 65 and older.

Brief 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. 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;

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Detection of impaired level of consciousness in older ED patients
timeFrame: First 30 minute of presentation to the emergency department
measure: Detection of impaired content of consciousness in older ED patients
timeFrame: First 30 minute of presentation to the emergency department
Secondary outcomes:
measure: Mortality
timeFrame: 1 and 3 month mortality after patient enrolled
Other outcomes:
Locations:
city: Nevsehir
country: Turkey
facility: Nevsehir State Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.