Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Adverse Drug Related Events

Detailed Description

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
• Enrollment (Anticipated): 1588

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Emergency Department, Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Emergency Department, St Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Adults over the age of 19 years
• Reported having used at least one prescription or over-the-counter medication in the 2 weeks prior to presentation
• Speak English and/or translator available at the time of presentation.

Exclusion Criteria:

• Patients previously enrolled
• Patients transferred directly to an admitting service.
• Patients who leave prior to being seen or against medical advice.
• Patients returning to the ED for a scheduled revisit.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health; Michael Smith Foundation for Health Research; Canadian Patient Safety Institute
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2008

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (ESTIMATE): August 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2011
• Last Update Submitted That Met QC Criteria: February 15, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: patient safety; clinical decision support; Adverse drug event; harm; Adverse drug related event
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: H08-00510