Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT00727610|
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : February 17, 2011
|Condition or disease|
|Adverse Drug Related Events|
Background Between 9250 and 23,750 Canadians die each year because of preventable adverse events related to medical care. ADREs account for 50% of all preventable adverse events and cause up to 12% of ED visits. Unfortunately, emergency physicians recognize only half of all ADREs, missing crucial opportunities to intervene.
Objective The objective of this study is to derive a clinical decision rule that accurately stratifies patients presenting to the ED into risk categories for drug-related morbidity. This instrument will allow early identification of clinically significant ADREs allowing rational referral for medication optimization, treatment of ADREs and prevention of future events.
Hypothesis The development of a rapid, user-friendly reliable clinical decision rule for ADREs in patients presenting to the ED is feasible.
Methodology This prospective observational study will evaluate predictor variables (from the history, physical examination and laboratory tests) for ADREs in a representative sample of ED patients using standardized assessments by emergency nurses and physicians. Inter-rater agreement of predictor variables will be measured, and clinical pharmacists, blinded to the nursing and physician assessments, will use a standardized, validated algorithm to identify ADREs. Recursive partitioning and/or logistic regression analysis will be used to determine the optimal combination of predictor variables to detect the presence of an ADRE. We will report diagnostic test characteristics of the derived clinical decision rule. Validation of the clinical decision rule is planned in a future study.
|Study Type :||Observational|
|Estimated Enrollment :||1588 participants|
|Official Title:||Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department|
|Study Start Date :||May 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727610
|Canada, British Columbia|
|Emergency Department, Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Emergency Department, St Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Corinne M. Hohl||University of British Columbia|
|Study Chair:||Jeffrey R. Brubacher||University of British Columbia|
|Study Director:||Samuel B. Sheps||University of British Columbia|
|Study Director:||Linda Dempster||University of British Columbia|
|Study Director:||Garth Hunt||University of British Columbia|
|Study Director:||Claude Stang||University of British Columbia|
|Study Director:||Janet Joy||University of British Columbia|
|Study Director:||Peter Loewen||University of British Columbia|
|Study Director:||Matthew Wiens||University of British Columbia|