Adverse Drug EventsCMRNCT01164137
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care
A study testing Medication Reconciliation in people with Adverse Drug Events, run by Westview Physician Collaborative at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Events
- What is being tested?
- Medication Reconciliation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients attending the WestView Health Centre Medicine/Family Health Unit with at least one medication at discharge.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Adverse Drug Events
- Being tested
- Medication Reconciliation
- Keywords
- Adverse Drug Events, Medication Reconciliation, Pharmacist-led Intervention
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication ReconciliationBehavioural
A pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
| Study group | Role | What they receive |
|---|---|---|
| Medication Reconciliation Intervention | Experimental | Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies. Receives: Behavioral: Medication Reconciliation |
| Medication Reconciliation Non-Interven. | No intervention | Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
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.
Measured: 6 Months
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.
Measured: 9 Months
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.
Measured: 12 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startNov 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adverse Drug EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westview Physician Collaborative
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allan Bailey, M.D., Principal investigator, Westview Physician CollaborativeGrace Moe, M.Sc.P.T., Study director, WestView Primary Care Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164137
- Sponsor's protocol ID
- CMPA#2026
- Acronym
- CMR
- Status last verified
- Feb 2013
- First submitted
- 14 Jul 2010
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01164137
- Acronym / sponsor ID
- CMR / CMPA#2026
- Conditions
- Adverse Drug Events
- Keywords
- Adverse Drug Events, Medication Reconciliation, Pharmacist-led Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Westview Physician CollaborativeUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Posted 30 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Reconciliation Intervention | Experimental | Behavioral: Medication ReconciliationParticipants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies. |
| Medication Reconciliation Non-Interven. | No intervention | –Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients attending the WestView Health Centre Medicine/Family Health Unit with at least one medication at discharge.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication ReconciliationA pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies. | Behavioural | Medication Reconciliation Intervention |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Bailey, M.D. principal investigator
Westview Physician Collaborative
Grace Moe, M.Sc.P.T. study director
WestView Primary Care Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Reconciliation in people with Adverse Drug Events, run by Westview Physician Collaborative at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Services Utilization 3 Months Following Hospital Discharge (time frame: 3 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.