- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01814280
Reducing Medication Errors on Basis of an Individual Risk Assessment (MERIS1)
Differentiated Intervention Aimed at Reducing Medication Errors on Basis of an Individual Risk Assessment - a Pilot Study
Background:
Medication reviews performed on admission to hospitals reduce medication errors; however, evidence of effect on morbidity and mortality is currently inconsistent. It is known that patients' risks of experiencing medication errors are dependent on both patient- and drug factors, e.g. age, co-morbidity, number of drugs, risk of side effects.
Aim and hypothesis:
The aim of this pilot study is to study acute medical patients' risk of getting a medication error based on an algorithm that takes into account both patient and drug related factors. Secondary, the investigators will explore whether our methods are applicable in a randomised controlled trial. The investigators will also decide the number of patients in a randomised controlled trial based on this pilot study.
The hypothesis is that an algorithm that has already been developed can stratify patients according to their risk of experiencing a medication error.
Methods:
100 acute admitted patients will be risk stratified at admission (>8 hours after). The patients who have highest risks of medication errors will receive a medication review performed by either a clinical pharmacist or a clinical pharmacologist.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University Hospital,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acutely admitted patients
- Age>17 years
Exclusion Criteria:
- Dying patients
- Suicial patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Medication review
Medication review performed by either a clinical pharmacist or a clinical pharmacologist
|
Medication review performed by either a clinical pharmacist or a clinical pharmacologist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication errors
Time Frame: During the patients' hospital stay
|
The patients' electronic medical record will be assessed for medication errors during the patients' hospitalization.
It will be assesed by a clinical pharmacologist to assess the validity of the algorithm.
Medication errors are defined as errors in prescriptions that either harm or have the potential to harm the patients.
|
During the patients' hospital stay
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MERIS1
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