Adverse Drug Related EventsNCT00727610
Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department
An observational study of Adverse Drug Related Events, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adverse Drug Related Events
- How many people
- 1,588 participants
- Where
- 2 sitesCanada
- Study dates
- May 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Emergency Department, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Emergency Department, St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
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.
Read the 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.
- Conditions
- Adverse Drug Related Events
- Keywords
- Adverse drug event, harm, patient safety, clinical decision support, Adverse drug related event
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug Related EventsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Patient Safety Institute, Michael Smith Foundation for Health Research, Vancouver Coastal Health
- Investigators
- Corinne M. Hohl, Principal investigator, University of British ColumbiaJeffrey R. Brubacher, Study chair, University of British ColumbiaSamuel B. Sheps, Study director, University of British ColumbiaLinda Dempster, Study director, University of British ColumbiaGarth Hunt, Study director, University of British ColumbiaClaude Stang, Study director, University of British ColumbiaJanet Joy, Study director, University of British ColumbiaPeter Loewen, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727610
- Sponsor's protocol ID
- H08-00510
- Status last verified
- Feb 2011
- First submitted
- 30 Jul 2008
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Screening Strategy for Community-based Adverse Drug Related Events in the Emergency Department
- ClinicalTrials.gov ID
- NCT00727610
- Acronym / sponsor ID
- H08-00510
- Conditions
- Adverse Drug Related Events
- Keywords
- Adverse drug event, harm, patient safety, clinical decision support, Adverse drug related event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,588 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Patient Safety Institute, Michael Smith Foundation for Health Research, Vancouver Coastal Health
- Study start
- May 2008
- First posted
- 4 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne M. Hohl principal investigator
University of British Columbia
Jeffrey R. Brubacher study chair
University of British Columbia
Samuel B. Sheps study director
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Related Events, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011; AzTrials last refreshed its copy on 26 Oct 2026.