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Reducing Medication Errors on Basis of an Individual Risk Assessment (MERIS1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01814280
First Posted: March 19, 2013
Last Update Posted: November 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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.


Condition Intervention
Drug Safety Other: Medication review

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Differentiated Intervention Aimed at Reducing Medication Errors on Basis of an Individual Risk Assessment - a Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Medication review
Medication review performed by either a clinical pharmacist or a clinical pharmacologist
Other: Medication review
Medication review performed by either a clinical pharmacist or a clinical pharmacologist

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acutely admitted patients
  • Age>17 years

Exclusion Criteria:

  • Dying patients
  • Suicial patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814280


Locations
Denmark
Aarhus University Hospital,
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01814280     History of Changes
Other Study ID Numbers: MERIS1
First Submitted: August 16, 2012
First Posted: March 19, 2013
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by University of Aarhus:
Medication errors
Medication review
Risk stratification
Patient safety