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

February 12, 2013 updated by: Westview Physician Collaborative

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Develop and test a community-based medication reconciliation process/intervention.
  2. 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.
  3. Design a risk prediction model that helps identify patients discharged from in-patient care with the highest level of need for the intervention.
  4. Determine whether a community-based medication reconciliation process/intervention adds risk reduction value to individuals who have undergone an in-hospital medication reconciliation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Stony Plain, Alberta, Canada, T7Z 2M7
        • Westview Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medication Reconciliation Intervention
Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.
Behavioral: Medication Reconciliation
A pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
No Intervention: Medication Reconciliation Non-Interven.
Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health Services Utilization 3 Months Following Hospital Discharge
Time Frame: 3 Months
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.
3 Months
Health Services Utilization 6 Months Following Hospital Discharge
Time Frame: 6 Months
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.
6 Months
Health Services Utilization 9 Months Following Hospital Discharge
Time Frame: 9 Months
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.
9 Months
Health Services Utilization 12 Months Following Hospital Discharge
Time Frame: 12 months
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.
12 months
Health Services Utilization 18 Months Following Hospital Discharge
Time Frame: 18 months
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Westview Physician Collaborative

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allan Bailey, M.D., Westview Physician Collaborative
  • Study Director: Grace Moe, M.Sc.P.T., WestView Primary Care Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMPA#2026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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