Reducing Medication Errors on Basis of an Individual Risk Assessment

Drug Safety Clinical Trial

— MERIS1  

Official title:

Differentiated Intervention Aimed at Reducing Medication Errors on Basis of an Individual Risk Assessment - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814280
• Other study ID #: MERIS1
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: November 27, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acutely admitted patients

• Age>17 years

Exclusion Criteria:

• Dying patients

• Suicial patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug Safety

Intervention

Other:
• Medication review
Medication review performed by either a clinical pharmacist or a clinical pharmacologist

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital,	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication errors	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	Yes