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

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

Study Overview

• Status: Completed
• Conditions: Adverse Drug Events; Adverse Drug Reactions; Medication-related Problems
• Intervention / Treatment: Other: Pharmacist-led medication review

• Study Type: Interventional
• Enrollment (Actual): 10805
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada
      • Lions Gate Hospital
    • Richmond, British Columbia, Canada
      • Richmond Hospital
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led medication review; Pharmacist-led medication review in the ED	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.
No Intervention: Usual care; Usual care includes nurse-led medication reconciliation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		30 days
Hospital admission		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.	30 days
Unplanned emergency department re-visit		7 days
Unplanned readmission		30 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Corinne M Hohl, MD, MHSc, University of British Columbia

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Emergencies; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: H11-01815