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Sponsors and Collaborators: |
University of British Columbia Canadian Patient Safety Institute Michael Smith Foundation for health research Vancouver Coastal Health Authority |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00727610 |
Adverse Drug Related Events (ADREs) are a leading cause of Emergency Department (ED) visits in Canada. However emergency physicians recognize only half of all ADREs in patients presenting to the ED, missing opportunities to intervene. The objective of this study is to develop a screening strategy that identifies patients with ADREs. Our hypothesis is that the development of a user-friendly, reliable screening strategy for ADREs in patients presenting to the ED is feasible. We believe that this will lead to improved patient care.
Condition |
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Adverse Drug Related Events |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Development of a Screening Strategy for Community-Based Adverse Drug Related Events in the Emergency Department |
Estimated Enrollment: | 1588 |
Study Start Date: | May 2008 |
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Adults presenting to the emergency departments of participating institutions who have used at least one prescription or over-the-counter medication in the 2 weeks prior to presentation.
Inclusion Criteria:
Exclusion Criteria:
Contact: Katayoun Bahadori | (604) 875-4111 ext 63467 | Kati.bahadori@ubc.ca |
Canada, British Columbia | |
Emergency Department, Vancouver General Hospital | Recruiting |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Contact: Katayoun Bahadori (604) 875-4111 ext 63467 | |
Emergency Department, St Paul's Hospital | Recruiting |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Contact: Katayoun Bahadori (604) 875-4111 ext 63467 |
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 |
Responsible Party: | University of British Columbia ( Dr. Corinne M. Hohl/Scientist ) |
Study ID Numbers: | H08-00510 |
Study First Received: | July 30, 2008 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00727610 |
Health Authority: | Canada: Health Canada |
Adverse drug event harm patient safety clinical decision support Adverse drug related event |
Emergencies |
Disease Attributes Pathologic Processes |