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

This study has been completed.
Sponsor:
Collaborators:
Canadian Patient Safety Institute
Michael Smith Foundation for Health Research
Vancouver Coastal Health
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00727610
First received: July 30, 2008
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

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
Adverse Drug Related Events

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department

Further study details as provided by University of British Columbia:

Estimated Enrollment: 1588
Study Start Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00727610

Locations
Canada, British Columbia
Emergency Department, St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Emergency Department, Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Canadian Patient Safety Institute
Michael Smith Foundation for Health Research
Vancouver Coastal Health
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
  More Information

No publications provided

Responsible Party: Dr. Corinne M. Hohl/Scientist, University of British Columbia
ClinicalTrials.gov Identifier: NCT00727610     History of Changes
Other Study ID Numbers: H08-00510
Study First Received: July 30, 2008
Last Updated: February 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Adverse drug event
harm
patient safety
clinical decision support
Adverse drug related event

ClinicalTrials.gov processed this record on October 22, 2014