Adverse Drug EventsNCT02122965
The Effect of Medication Review in High-risk Emergency Department Patients
A study testing Pharmacist-led medication review in people with Adverse Drug Events and Adverse Drug Reactions, run by University of British Columbia at 3 sites in Canada.
Trial summary
Adverse drug events are unintended and harmful events related to medication use and a leading cause of emergency department visits, unplanned hospital admissions and deaths. In the emergency department, physicians frequently misdiagnose adverse drug events leading to treatment delays. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adverse Drug Events, Adverse Drug Reactions, Medication-related Problems
- What is being tested?
- Pharmacist-led medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,805 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2012to Feb 2014
- Phase
- Interventional
- 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
Who may be able to join
- Consecutive high-risk patients, aged 19 years or older, presenting to a participating emergency department when a medication review pharmacist is on duty are eligible for enrolment.
Who cannot join
- We will exclude patients categorized as Canadian Triage Acuity Score (CTAS) 1 as they require immediate resuscitation, those presenting for multisystem trauma (e.g., penetrating trauma), scheduled visits (e.g., for intravenous antibiotics), sexual assaults, pregnancy-related complications, social problems, and those for whom we cannot link data to administrative records (e.g., out-of-province patients).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Lions Gate Hospital
North Vancouver, British Columbia
Richmond Hospital
Richmond, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: The Effect of Medication Review in High-risk Emergency Department Patients: Evaluation of a Quality Improvement Program
Adverse drug events are unintended and harmful events related to medication use and a leading cause of emergency department visits, unplanned hospital admissions and deaths. In the emergency department, physicians frequently misdiagnose adverse drug events leading to treatment delays. Our objective is to evaluate the effect of pharmacist-led medication review in high-risk emergency department patients on prolonged hospital stay.
This prospective multi-centre, quasi-randomized study is nested within an existing quality improvement program. Triage nurses flag incoming emergency department patients at high-risk for adverse drug events by applying a clinical decision rule consisting of four variables (co-morbid conditions, antibiotic use within 7 days, medication changes within 28 days, and age). Consecutive eligible high-risk patients are enrolled into the medication review study, and systematically allocated to pharmacist-led medication review or usual care. In the intervention group, medication review pharmacists collect best-possible medication histories, review the patient's medications for appropriateness and adverse drug events, and communicate the results of medication review to patients, caregivers and physicians. In the usual care group, physicians refer patients to onsite pharmacists for medication management questions on an as needed basis. Health outcomes are assessed using anonymized data linkage to administrative health databases. The primary outcome is the percent of days spent in hospital during the first 30 days after the index emergency department visit
- Being tested
- Pharmacist-led medication review
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led medication reviewOther
Medication review is a structured, critical examination of a patient's medications with the objective of reaching agreement with the patient about treatment, optimizing the medications' impact, and minimizing the number of medication-related problems and adverse drug events.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-led medication review | Experimental | Pharmacist-led medication review in the ED Receives: Other: Pharmacist-led medication review |
| Usual care | No intervention | Usual care includes nurse-led medication reconciliation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of days spent in hospital over 30 days
The primary outcome will be the proportion of days spent in hospital during the follow up period. This outcome captures all days in hospital that were incurred during the index admission as well as during any readmissions.
Measured: 30 days
Secondary outcomes (5)
Hospital admission
Measured: on the 1 day of medication review
Prolonged hospital stay
Prolonged hospital stay will be defined as a length of stay that is greater than the median length of stay observed by high-risk patents during the pilot period.
Measured: 30 days
Unplanned emergency department re-visit
Measured: 7 days
Mortality
Measured: 30 days
Unplanned readmission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,805 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne M Hohl, MD, MHSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122965
- Sponsor's protocol ID
- H11-01815
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medication Review in High-risk Emergency Department Patients: Evaluation of a Quality Improvement Program
- ClinicalTrials.gov ID
- NCT02122965
- Acronym / sponsor ID
- H11-01815
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,805 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Apr 2014 (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 events are unintended and harmful events related to medication use and a leading cause of emergency department visits, unplanned hospital admissions and deaths. In the emergency department, physicians frequently misdiagnose adverse drug events leading to treatment delays. Our objective is to evaluate the effect of pharmacist-led medication review in high-risk emergency department patients on prolonged hospital stay.
This prospective multi-centre, quasi-randomized study is nested within an existing quality improvement program. Triage nurses flag incoming emergency department patients at high-risk for adverse drug events by applying a clinical decision rule consisting of four variables (co-morbid conditions, antibiotic use within 7 days, medication changes within 28 days, and age). Consecutive eligible high-risk patients are enrolled into the medication review study, and systematically allocated to pharmacist-led medication review or usual care. In the intervention group, medication review pharmacists collect best-possible medication histories, review the patient's medications for appropriateness and adverse drug events, and communicate the results of medication review to patients, caregivers and physicians. In the usual care group, physicians refer patients to onsite pharmacists for medication management questions on an as needed basis. Health outcomes are assessed using anonymized data linkage to administrative health databases. The primary outcome is the percent of days spent in hospital during the first 30 days after the index emergency department visit
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led medication review | Experimental | Other: Pharmacist-led medication reviewPharmacist-led medication review in the ED |
| Usual care | No intervention | –Usual care includes nurse-led medication reconciliation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive high-risk patients, aged 19 years or older, presenting to a participating emergency department when a medication review pharmacist is on duty are eligible for enrolment.
Key exclusion criteria (1 listed)
- We will exclude patients categorized as Canadian Triage Acuity Score (CTAS) 1 as they require immediate resuscitation, those presenting for multisystem trauma (e.g., penetrating trauma), scheduled visits (e.g., for intravenous antibiotics), sexual assaults, pregnancy-related complications, social problems, and those for whom we cannot link data to administrative records (e.g., out-of-province patients).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led medication reviewMedication review is a structured, critical examination of a patient's medications with the objective of reaching agreement with the patient about treatment, optimizing the medications' impact, and minimizing the number of medication-related problems and adverse drug events. | Other | Pharmacist-led medication review |
Primary outcome
Proportion of days spent in hospital over 30 days
Time frame: 30 days
The primary outcome will be the proportion of days spent in hospital during the follow up period. This outcome captures all days in hospital that were incurred during the index admission as well as during any readmissions.
5 secondary outcomes
Hospital admission
Time frame: on the 1 day of medication review
Prolonged hospital stay
Time frame: 30 days
Unplanned emergency department re-visit
Time frame: 7 days
Mortality
Time frame: 30 days
Unplanned readmission
Time frame: 30 days
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 25 Apr 2014.
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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, MD, MHSc principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led medication review in people with Adverse Drug Events and Adverse Drug Reactions, run by University of British Columbia at 3 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 1 inclusion and 1 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Proportion of days spent in hospital over 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
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 25 Apr 2014.