Documentation of Altered Mental Status

September 20, 2017 updated by: Mehmet Ali Aslaner, Nevsehir Public Hospital
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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nevsehir, Turkey
        • Nevsehir State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 110 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All older emergency department patients aged 65 and older.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 30 minute of presentation to the emergency department
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.
First 30 minute of presentation to the emergency department

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 1 and 3 month mortality after patient enrolled
1 and 3 month mortality after patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion

June 1, 2017

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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