Effect of Medication Reviews Performed in High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01819974
First received: March 18, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention
Patients in Highest Medication Error Risk
Other: Stratified medication review

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Medication errors [ Time Frame: During hospitalization ie. between 8 hours and approximately 20 days ] [ Designated as safety issue: Yes ]
    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:
  • hospital readmissions (all-cause) [ Time Frame: 3 months after discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Dying patients
  • Suicidal patients
  • Intoxicated 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: NCT01819974

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

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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01819974     History of Changes
Other Study ID Numbers: MERIS2
Study First Received: March 18, 2013
Last Updated: November 27, 2013
Health Authority: Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on September 16, 2014