Documentation of Altered Mental Status
1 other identifier
observational
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 21, 2017
September 1, 2017
5 months
December 25, 2016
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Mortality
1 and 3 month mortality after patient enrolled
Eligibility Criteria
All older emergency department patients aged 65 and older.
You may qualify if:
- All older ED patients
You may not qualify if:
- Unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (STE MI, severe dyspnea, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nevsehir State Hospital
Nevşehir, Turkey (Türkiye)
Related Publications (3)
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: 27765479BACKGROUNDHan 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: 23177603BACKGROUNDEuropean 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: 25300023BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Emergency Physician
Study Record Dates
First Submitted
December 25, 2016
First Posted
February 2, 2017
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
September 21, 2017
Record last verified: 2017-09