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Observational Study to Reduce Medication Errors

NCT ID: NCT01734642

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Medication Errors

Keywords

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Medication errors, patients hospitalized, ADRs, adverse events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale S.Bortolo -Vicenza, Italy

UNKNOWN

Sponsor Role collaborator

Ospedale Mater Salutis-Legnago(Verona), Italy

UNKNOWN

Sponsor Role collaborator

Ospedale Fra Castoro- San Bonifacio (Verona), Italy

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role collaborator

Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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GIAMPAOLO VELO

Prof. of Pharmacology and Director of the Clinical Pharmacology Unit, Verona, Italy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giampaolo Velo, Medicine and Surgery

Role: STUDY_DIRECTOR

The University of Verona, Verona , Italy

Locations

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Mater Salutis Hospital

Legnago, Verona, Italy

Site Status

Fracastoro Hospital

San Bonifacio, Verona, Italy

Site Status

University Hospital of Verona (AOUI), Verona, Italy

Verona, Verona, Italy

Site Status

San Bortolo Hospital

Vicenza, Vicenza, Italy

Site Status

Countries

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Italy

Central Contacts

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Lara Magro, Chemistry and pharm. technol.

Role: CONTACT

Phone: 0039 045/8027147

Email: [email protected]

Ermelinda Viola, Chemistry and pharm. technol.

Role: CONTACT

Phone: 0039 045/8124904

Email: [email protected]

Facility Contacts

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Giampaolo Velo, medicine

Role: primary

Lara Magro, pharmacy

Role: backup

Giampaolo Velo, Medicine

Role: primary

Ermelinda Viola, pharmacy

Role: backup

Giampaolo Velo, Medicine

Role: primary

Lara Magro, pharmacy

Role: backup

Giampaolo Velo, Medicine

Role: primary

Ermelinda Viola, Pharmacy

Role: backup

References

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Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009 Jun;67(6):599-604. doi: 10.1111/j.1365-2125.2009.03415.x.

Reference Type BACKGROUND
PMID: 19594526 (View on PubMed)

Velo GP, Minuz P. Medication errors: prescribing faults and prescription errors. Br J Clin Pharmacol. 2009 Jun;67(6):624-8. doi: 10.1111/j.1365-2125.2009.03425.x.

Reference Type BACKGROUND
PMID: 19594530 (View on PubMed)

Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma'Luf N, Boyle D, Leape L. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc. 1999 Jul-Aug;6(4):313-21. doi: 10.1136/jamia.1999.00660313.

Reference Type BACKGROUND
PMID: 10428004 (View on PubMed)

Lewis PJ, Dornan T, Taylor D, Tully MP, Wass V, Ashcroft DM. Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review. Drug Saf. 2009;32(5):379-89. doi: 10.2165/00002018-200932050-00002.

Reference Type BACKGROUND
PMID: 19419233 (View on PubMed)

Other Identifiers

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31025

Identifier Type: -

Identifier Source: org_study_id