Observational Study to Reduce Medication Errors (OSME)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Universita di Verona
Sponsor:
Collaborators:
Ospedale S.Bortolo -Vicenza, Italy
Ospedale Mater Salutis-Legnago(Verona), Italy
Ospedale Fra Castoro- San Bonifacio (Verona), Italy
The University Hospital of Verona, (AOUI), Verona , Italy
Information provided by (Responsible Party):
GIAMPAOLO VELO, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01734642
First received: November 21, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

A medication error is a failure in the treatment process that leads to, or has the potential to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in hospital. They can occur in different phases of the therapeutic process (prescribing, distribution, administration and monitoring) and have significant impact on morbidity and mortality. Prescribing faults and prescription errors are major problem among medication errors .Prescription errors account for 70 % of medication errors that could potentially result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 % of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises from a medication error it is potentially preventable. The medication errors project was devised to analyze and limit through educational audit and other tools, as much as possible, damages due to the therapeutic process. The project will include 5 phases. Preliminary phase: organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health professionals of involved units will review all patient charts and will register all adverse drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II :educational audits directed to health professionals will be organized. Tools to reduce the medication errors will be proposed. Phase III: the same procedure of the first phase. Final phase (IV): analysis of data with publication of a scientific article.


Condition
Medication Errors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Number of participants with adverse drug reactions due to medication errors occurring during hospitalization [ Time Frame: within the first 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with preventable ADRs due to medication errors [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • the impact of educational audit will be evaluated [ Time Frame: during the final phase ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PATIENT HOSPITALIZED
ALL THE PATIENTS HOSPITALIZED IN THE INVOLVED UNITS WHO GAVE THEIR INFORMED CONSENT. PATIENTS HOSPITALIZED DURING THE WEEK-END WILL BE ENROLLED ON the next MONDAY

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients from 18 to 65 and over 65 years old hospitalized in the involved departments during the study period.

Criteria

Inclusion Criteria:

  • all patients hospitalized in the involved units who gave their informed consent. Patients hospitalized during the week-end will be enrolled on the next monday.

Exclusion Criteria:

  • all patients with evident mental and physical problems and all patients who did not give their informed consent.
  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: NCT01734642

Contacts
Contact: Lara Magro, Chemistry and pharm. technol. 0039 045/8027147 lara.magro@univr.it
Contact: Ermelinda Viola, Chemistry and pharm. technol. 0039 045/8124904 ermelinda.viola@univr.it

Locations
Italy
Mater Salutis Hospital Not yet recruiting
Legnago, Verona, Italy, 37045
Contact: Giampaolo Velo, medicine    0039 045/8127450    giampaolo.velo@univr.it   
Contact: Lara Magro, pharmacy    0039 045/8027147    lara.magro@univr.it   
Fracastoro Hospital Not yet recruiting
San Bonifacio, Verona, Italy, 37047
Contact: Giampaolo Velo, Medicine    0039 045/8127450    giampaolo.velo@univr.it   
Contact: Ermelinda Viola, pharmacy    0039 045/8124904    ermelinda.viola@univr.it   
University Hospital of Verona (AOUI), Verona, Italy Not yet recruiting
Verona, Italy, 37100
Contact: Giampaolo Velo, Medicine    0039 045/8127450    giampaolo.velo@univr.it   
Contact: Lara Magro, pharmacy    0039 045/8027147    lara.magro@univr.it   
Principal Investigator: Giampaolo Velo, Medicine         
San Bortolo Hospital Not yet recruiting
Vicenza, Italy, 36100
Contact: Giampaolo Velo, Medicine    0039 045/8127450    giampaolo.velo@univr.it   
Contact: Ermelinda Viola, Pharmacy    0039 045/8124904    ermelinda.viola@univr.it   
Sponsors and Collaborators
Universita di Verona
Ospedale S.Bortolo -Vicenza, Italy
Ospedale Mater Salutis-Legnago(Verona), Italy
Ospedale Fra Castoro- San Bonifacio (Verona), Italy
The University Hospital of Verona, (AOUI), Verona , Italy
Investigators
Study Director: Giampaolo Velo, Medicine and Surgery The University of Verona, Verona , Italy
  More Information

Publications:
Responsible Party: GIAMPAOLO VELO, Prof. of Pharmacology and Director of the Clinical Pharmacology Unit, Verona, Italy, Universita di Verona
ClinicalTrials.gov Identifier: NCT01734642     History of Changes
Other Study ID Numbers: 31025
Study First Received: November 21, 2012
Last Updated: November 28, 2012
Health Authority: Italy: The Italian Medicines Agency(AIFA)

Keywords provided by Universita di Verona:
Medication errors, patients hospitalized, ADRs, adverse events

ClinicalTrials.gov processed this record on October 29, 2014