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

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01814280
First received: August 16, 2012
Last updated: November 27, 2013
Last verified: November 2013
  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: 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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acutely admitted patients
  • Age>17 years

Exclusion Criteria:

  • Dying patients
  • Suicial patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814280

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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01814280     History of Changes
Other Study ID Numbers: MERIS1
Study First Received: August 16, 2012
Last Updated: November 27, 2013
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on October 19, 2014