NCT00727610

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,588

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

First QC Date

July 30, 2008

Last Update Submit

February 15, 2011

Conditions

Adverse Drug Related Events

Keywords

Adverse drug eventharmpatient safetyclinical decision supportAdverse drug related event

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emergency Department, Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Emergency Department, St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Corinne M. Hohl

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Jeffrey R. Brubacher

    University of British Columbia

    STUDY CHAIR

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 4, 2008

Study Start

May 1, 2008

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

CA(2)