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Effect of Medication Reviews Performed in High Risk Patients

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ClinicalTrials.gov Identifier: NCT01819974
Recruitment Status : Unknown
Verified November 2013 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : March 28, 2013
Last Update Posted : November 28, 2013
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment
Patients in Highest Medication Error Risk Other: Stratified medication review

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial
Study Start Date : April 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
The normal procedure at the ward
Active Comparator: Stratified medication review
Medication review performed by either a clinical pharmacist or a clinical pharmacologist in patients with highest medication error risk
Other: Stratified medication review
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.

Primary Outcome Measures :
  1. Medication errors [ Time Frame: During hospitalization ie. between 8 hours and approximately 20 days ]
    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.

Secondary Outcome Measures :
  1. hospital readmissions (all-cause) [ Time Frame: 3 months after discharge ]

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

Inclusion Criteria:

  • Acutely admitted
  • >17 years
  • Patients being treated with at least one drug at admission

Exclusion Criteria:

  • Dying patients
  • Suicidal patients
  • Intoxicated patients

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): NCT01819974

Contact: Dorthe K Bonnerup, Msc +4560472921 dortbonn@rm.dk
Contact: Lars P Nielsen, MD lpn@farm.au.dk

Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Dorthe K Bonnerup, Msc         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01819974     History of Changes
Other Study ID Numbers: MERIS2
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013