Delirium Clinical Trial
Official title:
Estimation of Delirium Data Completeness and Analysis of Underlying Systems Factors in a Retrospective Cohort
Verified date | September 2019 |
Source | Efficacy Care R&D Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 50000 |
Est. completion date | November 2020 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. All postoperative patients aged 18 years and older; and 2. Undergoing unplanned admission to an intensive care unit (ICU); or 3. 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 4. Postoperative Central Nervous System (CNS) event (e.g., CVA, seizures, coma) during or within 48 hours of operation or administration of anesthesia; AND 5. Respiratory failure not present prior to the 25th hour of hospitalization or not present before surgery; Exclusion Criteria: 1. Delirium present on admission; or 2. 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). |
Country | Name | City | State |
---|---|---|---|
Israel | Haddasah Medical Center | Jerusalem | IL |
Lead Sponsor | Collaborator |
---|---|
Efficacy Care R&D Ltd | Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Severity of delirium | CAM-S Score:: Delirium severity measure based on the Confusion Assessment Method (CAM-S). The severity score is created by an additive summary of the ratings ranging from 0-19 (long form). Higher scores indicate more severe delirium. |
30 days | |
Secondary | Severity of delirium | DRS-R98 Score:: The Delirium Rating Scale (DRS) is a widely used delirium rating instrument that specifically, sensitively, and reliably measures delirium symptoms as rated by a psychiatrist or trained clinician. Severity items are rated on a scale of 0-3 and diagnostic items are rated on a scale of 0-2 or 0-3. The maximum possible score for severity items is 39, while the maximum total score is 46. Higher scores indicate more severe delirium; score of 0 indicates no delirium. |
30 days | |
Secondary | ICU LOS | days of Unplanned ICU hospitalization | 30 days | |
Secondary | In-patient mortality | In-patient mortality | 12 months | |
Secondary | ICER | The incremental cost-effectiveness ratio (ICER) | 12 months | |
Secondary | Readmission | 30-day readmission | 30 days | |
Secondary | in hospital mortality | 30-day hospital mortality | 30 days | |
Secondary | Direct Costs of Hospitalisation | Total Hospitalization costs, including procedural complication costs, and/or any costs of pre-discharge treatment, drug, procedure-related complications and re-interventions; | 30 days | |
Secondary | LOS | days of none-ICU hospitalization | 30 days |
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