Estimation of Delirium Data Completeness

NCT04084821 | Unknown DMC

• 1 other identifier: Delirium-Retrospective Cohort
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

Currently physicians and nurses rely on their own clinical skills and experience to diagnose and record 'delirium' in the Electronic Health Records (EHR). This study aims to determine how delirium as a diagnosis is documented by clinicians in the EHR at Hadassah Hospital. The knowledge gained from this study will support the design of a better surveillance approach to monitoring delirium events in postoperative patients using electronic healthcare recorded data. There is considerable uncertainty surrounding the quality of 'delirium' records in the Electronic Health Records (EHR). The reliability of this chart estimation has become questionable in the absence of an objective definition of 'delirium' and a lack of highly accurate diagnostic tools in the hospital setting. Given the difficulty of accurately identifying delirium and the deficiency in the quality of EHR documentation, it is not surprising that delirium is grossly underestimated, undertreated, not properly recorded in the EHR or misreported. Data concordance plays a major role in documentation quality, especially for data-mining and knowledge extraction analysis, and therefore it is essential to address the reliability of 'delirium' labeled data within the EHR system.

Conditions

Delirium; Delirium Drug-Induced; Delirium Confusional State; Delirium, Cause Unknown; Delirium of Mixed Origin

Outcome Measures

Primary Outcomes (1)

• Postoperative Delirium

  The primary outcomes measured in this study are the number of cases determining the presence, absence, or likelihood of subsequent development of postoperative delirium. (ICD-9-CM Codes Considered Evidence of Delirium: 290.3 Senile dementia with delirium; or 291 Alcohol-induced mental disorders; or 291.0 Alcohol withdrawal delirium; or 292 Drug-induced mental disorders; or 292.81 Drug-induced delirium; or 293 Transient mental disorders due to conditions classified elsewhere; or 293.1 Subacute delirium; or 780.09 Other alteration of consciousness )

  12 months

Secondary Outcomes (9)

• Severity of delirium

  30 days

• Severity of delirium

  30 days

• ICU LOS

  30 days

• In-patient mortality

  12 months

• ICER

  12 months

Interventions

none - observation only OTHER

Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample Size: 50,000 Gender: M - 25,000; F - 25000 approx. Age: 18 and older General Health Status: All postoperative patients undergoing unplanned admission to an intensive care unit (ICU). Total Number of Subjects Projected: It is expected that approximately 75,000 subjects will be enrolled (identified for further review) to produce 50,000 evaluable subjects.

You may qualify if:

• All postoperative patients aged 18 years and older; and
• Undergoing unplanned admission to an intensive care unit (ICU); or
• Major complications associated with either operating room procedure or anesthesia. Example: Cardiac or circulatory event and/or Cardiac arrest during or within 24 hours of operation or administration of anesthesia; or Acute myocardial infarction (AMI) during or within 48 hours of operation or administration of anesthesia; or
• Postoperative Central Nervous System (CNS) event (e.g., CVA, seizures, coma) during or within 48 hours of operation or administration of anesthesia; AND
• Respiratory failure not present prior to the 25th hour of hospitalization or not present before surgery;

You may not qualify if:

• Delirium present on admission; or
• any psychotic or degenerative related diagnosis on admission (e.g. Senile and presentile dementias such as Alzheimer's or Pick's dementia, Creutzfeldt-Jakob disease, Huntington's chorea, Wilson's disease).

Sponsors & Collaborators

• Efficacy Care R&D Ltd: lead
• Hadassah Medical Organization: collaborator

Study Sites (1)

Haddasah Medical Center

Jerusalem, IL, Israel

Location

MeSH Terms

Conditions

Delirium; Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: October 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)