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Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care (CMR)

Primary Purpose

Adverse Drug Events

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Medication Reconciliation
Sponsored by
Westview Physician Collaborative
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Events focused on measuring Adverse Drug Events, Medication Reconciliation, Pharmacist-led Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients attending the WestView Health Centre Medicine/Family Health Unit with at least one medication at discharge.

Exclusion Criteria:

  • First Nations persons
  • Residents of continuing care or assisted living facilities
  • Persons not residing in the Edmonton, AB, Canada region
  • Persons who obtain a score of 19 or less on the Mini Mental State Examination (MMSE)

Sites / Locations

  • WestView Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medication Reconciliation Intervention

Medication Reconciliation Non-Interven.

Arm Description

Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.

Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.

Outcomes

Primary Outcome Measures

Health Services Utilization 3 Months Following Hospital Discharge
Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Health Services Utilization 6 Months Following Hospital Discharge
Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Health Services Utilization 9 Months Following Hospital Discharge
Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Health Services Utilization 12 Months Following Hospital Discharge
Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Health Services Utilization 18 Months Following Hospital Discharge
Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2010
Last Updated
February 12, 2013
Sponsor
Westview Physician Collaborative
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1. Study Identification

Unique Protocol Identification Number
NCT01164137
Brief Title
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care
Acronym
CMR
Official Title
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care: to Develop and Test a Community-based Medication Reconciliation Program and a Risk Prediction Model That Identifies High-risk Patient Groups
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Westview Physician Collaborative

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in the patients' home within 72 hours of hospital discharge.
Detailed Description
The goals of this initiative are to decrease the risk for medication errors at the hospital community interface of care, thus decreasing preventable adverse drug events and preventable drug-related health system utilization following hospital discharge. This initiative has four objectives that aim to: Develop and test a community-based medication reconciliation process/intervention. Design and conduct a randomized controlled trial to examine the impact of the intervention on post-discharge health services utilization by comparing a set of outcome variables between intervention and non-intervention groups. Design a risk prediction model that helps identify patients discharged from in-patient care with the highest level of need for the intervention. Determine whether a community-based medication reconciliation process/intervention adds risk reduction value to individuals who have undergone an in-hospital medication reconciliation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
Adverse Drug Events, Medication Reconciliation, Pharmacist-led Intervention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Medication Reconciliation Intervention
Arm Type
Experimental
Arm Description
Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.
Arm Title
Medication Reconciliation Non-Interven.
Arm Type
No Intervention
Arm Description
Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.
Intervention Type
Behavioral
Intervention Name(s)
Medication Reconciliation
Intervention Description
A pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
Primary Outcome Measure Information:
Title
Health Services Utilization 3 Months Following Hospital Discharge
Description
Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Time Frame
3 Months
Title
Health Services Utilization 6 Months Following Hospital Discharge
Description
Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Time Frame
6 Months
Title
Health Services Utilization 9 Months Following Hospital Discharge
Description
Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Time Frame
9 Months
Title
Health Services Utilization 12 Months Following Hospital Discharge
Description
Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Time Frame
12 months
Title
Health Services Utilization 18 Months Following Hospital Discharge
Description
Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients attending the WestView Health Centre Medicine/Family Health Unit with at least one medication at discharge. Exclusion Criteria: First Nations persons Residents of continuing care or assisted living facilities Persons not residing in the Edmonton, AB, Canada region Persons who obtain a score of 19 or less on the Mini Mental State Examination (MMSE)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Bailey, M.D.
Organizational Affiliation
Westview Physician Collaborative
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grace Moe, M.Sc.P.T.
Organizational Affiliation
WestView Primary Care Network
Official's Role
Study Director
Facility Information:
Facility Name
WestView Health Centre
City
Stony Plain
State/Province
Alberta
ZIP/Postal Code
T7Z 2M7
Country
Canada

12. IPD Sharing Statement

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Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care

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