The Effect of Medication Review in High-risk Emergency Department Patients

Adverse Drug Events Clinical Trial

Official title:

The Effect of Medication Review in High-risk Emergency Department Patients: Evaluation of a Quality Improvement Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122965
• Other study ID #: H11-01815
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: April 23, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10805
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adverse Drug Events
• Adverse Drug Reactions
• Drug-Related Side Effects and Adverse Reactions
• Medication-related Problems

Intervention

Other:
• Pharmacist-led medication review
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.

Locations

Country	Name	City	State
Canada	Lions Gate Hospital	North Vancouver	British Columbia
Canada	Richmond Hospital	Richmond	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days	No
Secondary	Hospital admission		on the 1 day of medication review	No
Secondary	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.	30 days	Yes
Secondary	Unplanned emergency department re-visit		7 days	Yes
Secondary	Mortality		30 days	Yes
Secondary	Unplanned readmission		30 days	Yes