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

NCT02122965 | Completed

• 1 other identifier: H11-01815
• Study Type: interventional
• Target: 10,805
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Adverse Drug Events; Adverse Drug Reactions; Medication-related Problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hospital admission

  on the 1 day of medication review

• Prolonged hospital stay

  30 days

• Unplanned emergency department re-visit

  7 days

• Mortality

  30 days

• Unplanned readmission

  30 days

Study Arms (2)

Pharmacist-led medication review

EXPERIMENTAL

Pharmacist-led medication review in the ED

Other: Pharmacist-led medication review

Usual care

NO INTERVENTION

Usual care includes nurse-led medication reconciliation.

Interventions

Pharmacist-led medication review OTHER

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.

Pharmacist-led medication review

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (3)

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Location

Richmond Hospital

Richmond, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Corinne M Hohl, MD, MHSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 25, 2014
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

CA (3)