Clinical trial NCT00727610: Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department
Official title: Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Related Events
Keywords: Adverse drug event
harm
patient safety
clinical decision support
Adverse drug related event
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Patient Safety Institute
name: Michael Smith Foundation for Health Research
name: Vancouver Coastal Health
First posted: 2008-08-04
Enrollment: 1588
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Emergency Department, Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Emergency Department, St Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Corinne M. Hohl
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Jeffrey R. Brubacher
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Samuel B. Sheps
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Linda Dempster
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Garth Hunt
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Claude Stang
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Janet Joy
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Peter Loewen
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Matthew Wiens
role: STUDY_DIRECTOR
References: