- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01819974
Effect of Medication Reviews Performed in High Risk Patients
November 27, 2013 updated by: University of Aarhus
Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial
The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Acutely admitted medical patients will be included after admission.
After inclusion and randomization the patients will be risk stratified with an existing algorithm according to risk of medication error.
The patients in the intervention group will receive a medication review performed by a clinical pharmacist if they are in high medication error risk.
Patients in highest medication error risk will recieve a medication review performed by a clinical pharmacologist.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- 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
-
-
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Aarhus, Denmark, 8000
- Recruiting
- Aarhus University Hospital
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Principal Investigator:
- Dorthe K Bonnerup, Msc
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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
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acutely admitted
- >17 years
- Patients being treated with at least one drug at admission
Exclusion Criteria:
- Dying patients
- Suicidal patients
- Intoxicated patients
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
The normal procedure at the ward
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|
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Active Comparator: Stratified medication review
Medication review performed by either a clinical pharmacist or a clinical pharmacologist in patients with highest medication error risk
|
A mediciation review will be performed in patients with high medication error rik.
Patients in the highest risk will receive the medication review from a clinical pharmacologist whereas patients assessed in lesser risk will receive the medication review from a clinical pharmacist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication errors
Time Frame: During hospitalization ie. between 8 hours and approximately 20 days
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Medication errors are defined as errors in prescribing that has the potential to harm patients or actually harm patients.
This will be assessed by checking the medical records.
Two independent experts will do this.
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During hospitalization ie. between 8 hours and approximately 20 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
hospital readmissions (all-cause)
Time Frame: 3 months after discharge
|
3 months after discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
April 1, 2013
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
March 18, 2013
First Submitted That Met QC Criteria
March 22, 2013
First Posted (Estimate)
March 28, 2013
Study Record Updates
Last Update Posted (Estimate)
November 28, 2013
Last Update Submitted That Met QC Criteria
November 27, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- MERIS2
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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