Documentation of Altered Mental Status

Altered Level of Consciousness Clinical Trial

Official title:

Documentation of Altered Mental Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040843
• Other study ID #: NevsehirPH
• Status: Completed
• Phase: N/A
• First received: December 25, 2016
• Last updated: September 20, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Nevsehir Public Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Although definition of AMS is so complicated, clinical documentation can be detected in these patients with AMS.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Altered Level of Consciousness
• Consciousness Disorders
• Mental Disorders

Locations

Country	Name	City	State
Turkey	Nevsehir State Hospital	Nevsehir

Sponsors (1)

Lead Sponsor	Collaborator
Nevsehir Public Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Aslaner MA, Boz M, Çelik 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of impaired level of consciousness in older ED patients	Arousal (level of consciousness) measured by the Richmond Agitation and Sedation Scale.	First 30 minute of presentation to the emergency department
Primary	Detection of impaired content of consciousness in older ED patients	Awareness (content of consciousness) measured by the 5 criteria list questionnaire.	First 30 minute of presentation to the emergency department
Secondary	Mortality		1 and 3 month mortality after patient enrolled