Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02122965
Other study ID # H11-01815
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02239237 - Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
Completed NCT02191358 - YouScript IMPACT Registry N/A
Completed NCT01179867 - Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge N/A
Completed NCT02059044 - Information Systems-enabled Outreach Program for Adverse Drug Events N/A
Completed NCT01164137 - Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care N/A
Completed NCT02482025 - The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial N/A
Completed NCT04692220 - Drug-Related Problems : Focus on Age and Diabetes
Completed NCT02378220 - Pharmacogenetic Testing Among Home Health Patients N/A
Completed NCT01337063 - Multi-Center Medication Reconciliation Quality Improvement Study N/A
Completed NCT02593916 - Response to Medication Registry
Completed NCT00013143 - Patient Profiling and Provider Feedback to Reduce Adverse Drug Events N/A
Withdrawn NCT00606606 - Reducing Adverse Drug Events in the Nursing Home N/A
Completed NCT02026453 - Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy N/A
Completed NCT02805270 - Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization N/A
Completed NCT01764204 - Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years N/A
Completed NCT01531088 - Enhancing the Detection and Management of Adverse Drug Events in Nursing Homes N/A
Completed NCT00780572 - Implementation of Real-time ADE Surveillance and Decision Support N/A
Completed NCT01091038 - Improving Safety by Basic Computerizing Outpatient Prescribing Phase 2/Phase 3
Recruiting NCT04479553 - Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
Active, not recruiting NCT00740675 - Ambulatory Medication Reconciliation Following Hospital Discharge N/A