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OpenTrials
Completed

NCT Number: NCT03040843

Documentation of Altered Mental Status

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.

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Key information

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nevsehir State Hospital

Nevşehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Mortality

    Time frame: 1 and 3 month mortality after patient enrolled

Sponsors and collaborators

Lead sponsor

Nevsehir Public Hospital

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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