<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040843</url>
  </required_header>
  <id_info>
    <org_study_id>NevsehirPH</org_study_id>
    <nct_id>NCT03040843</nct_id>
  </id_info>
  <brief_title>Documentation of Altered Mental Status</brief_title>
  <official_title>Documentation of Altered Mental Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nevsehir Public Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nevsehir Public Hospital</source>
  <brief_summary>
    <textblock>
      Altered mental status (AMS) is common in older patients. However there is a lack of&#xD;
      standardization in the definition and documentation of this compliant. Different perception&#xD;
      of AMS can cause negative impact on interpretation and obtaining scientific data. Although&#xD;
      definition of AMS is so complicated, clinical documentation can be detected in these patients&#xD;
      with AMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Basically, consciousness is the state of full awareness of the self and one's relationship to&#xD;
      the environment. There are 2 related areas of neurologic function that are connected to&#xD;
      consciousness: content (orientation and memory) and level (arousal and response to stimuli).&#xD;
&#xD;
      The mental changes are best looked for in terms of arousal, attention, alertness,&#xD;
      orientation, cognition, memory, affect, and perception. Arousal (level of consciousness) can&#xD;
      be detected by the Richmond Agitation and Sedation Scale. Others are related to content of&#xD;
      consciousness and can be evaluated by cognitive tests. After one month pilot study, the&#xD;
      investigators chose 5 features of content of consciousness due to easy applicable and&#xD;
      detectable;&#xD;
&#xD;
        1. Attention (counting numbers backwards from 20) (&gt;1 error positive)&#xD;
&#xD;
        2. Cognition (disorganized thinking; meaningless speech, irrelevant explanations)&#xD;
&#xD;
        3. Perception (visual or auditory hallucinations)&#xD;
&#xD;
        4. Memory (3 items recall) (&gt;1 error positive)&#xD;
&#xD;
        5. Orientation (day of week, month and year) (&gt;1 error positive)&#xD;
&#xD;
      These features are also combination of six item screener test and delirium symptoms.&#xD;
&#xD;
      All elderly patients (65 aged and older) presented to the emergency department, will be&#xD;
      assessed according to these two methods; content and level of consciousness. And also, every&#xD;
      patient's baseline status of consciousness will be obtained from surrogates who knows the&#xD;
      patient best. All changes from patient's baseline status will be recorded. The investigators&#xD;
      will investigate how changes are reflected in the clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date>June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of impaired level of consciousness in older ED patients</measure>
    <time_frame>First 30 minute of presentation to the emergency department</time_frame>
    <description>Arousal (level of consciousness) measured by the Richmond Agitation and Sedation Scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection of impaired content of consciousness in older ED patients</measure>
    <time_frame>First 30 minute of presentation to the emergency department</time_frame>
    <description>Awareness (content of consciousness) measured by the 5 criteria list questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 and 3 month mortality after patient enrolled</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1200</enrollment>
  <condition>Altered Level of Consciousness</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All older emergency department patients aged 65 and older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All older ED patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unknown baseline status, any trauma, and unable to assess mental status due to acute&#xD;
             clinical condition (STE MI, severe dyspnea, etc)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nevsehir State Hospital</name>
      <address>
        <city>Nevsehir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <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>
    <PMID>27765479</PMID>
  </reference>
  <reference>
    <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>
    <PMID>23177603</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25300023</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nevsehir Public Hospital</investigator_affiliation>
    <investigator_full_name>Mehmet Ali Aslaner</investigator_full_name>
    <investigator_title>Attending Emergency Physician</investigator_title>
  </responsible_party>
  <keyword>documentation</keyword>
  <keyword>altered mental status</keyword>
  <keyword>definition</keyword>
  <keyword>clinically</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040843
org study id: NevsehirPH
nct id: NCT03040843
lead sponsor: 
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Detection of impaired level of consciousness in older ED patients
time frame: First 30 minute of presentation to the emergency department
description: Arousal (level of consciousness) measured by the Richmond Agitation and Sedation Scale.
measure: Detection of impaired content of consciousness in older ED patients
time frame: First 30 minute of presentation to the emergency department
description: Awareness (content of consciousness) measured by the 5 criteria list questionnaire.
measure: Mortality
time frame: 1 and 3 month mortality after patient enrolled
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 110 Years
healthy volunteers: No
facility: 
country: Turkey
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.
PMID: 27765479
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.
PMID: 23177603
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.
PMID: 25300023
responsible party type: Principal Investigator
investigator affiliation: Nevsehir Public Hospital
investigator full name: Mehmet Ali Aslaner
investigator title: Attending Emergency Physician
mesh term: Consciousness Disorders