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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pharmacist-led medication review
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Events

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Lions Gate Hospital
  • Richmond Hospital
  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmacist-led medication review

Usual care

Arm Description

Pharmacist-led medication review in the ED

Usual care includes nurse-led medication reconciliation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospital admission
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.
Unplanned emergency department re-visit
Mortality
Unplanned readmission

Full Information

First Posted
April 15, 2014
Last Updated
April 23, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02122965
Brief Title
The Effect of Medication Review in High-risk Emergency Department Patients
Official Title
The Effect of Medication Review in High-risk Emergency Department Patients: Evaluation of a Quality Improvement Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events, Adverse Drug Reactions, Medication-related Problems

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10805 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist-led medication review
Arm Type
Experimental
Arm Description
Pharmacist-led medication review in the ED
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care includes nurse-led medication reconciliation.
Intervention Type
Other
Intervention Name(s)
Pharmacist-led medication review
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of days spent in hospital over 30 days
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital admission
Time Frame
on the 1 day of medication review
Title
Prolonged hospital stay
Description
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.
Time Frame
30 days
Title
Unplanned emergency department re-visit
Time Frame
7 days
Title
Mortality
Time Frame
30 days
Title
Unplanned readmission
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne M Hohl, MD, MHSc
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Richmond Hospital
City
Richmond
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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

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