Observational Study to Reduce Medication Errors

NCT01734642 | Unknown DMC

• 1 other identifier: 31025
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Medication Errors

Keywords

Medication errors, patients hospitalized, ADRs, adverse events

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse drug reactions due to medication errors occurring during hospitalization

  within the first 3 months

Secondary Outcomes (1)

• Number of participants with preventable ADRs due to medication errors

  3 months

Other Outcomes (1)

• the impact of educational audit will be evaluated

  during the final phase

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universita di Verona: lead
• Ospedale S.Bortolo -Vicenza, Italy: collaborator
• Ospedale Mater Salutis-Legnago(Verona), Italy: collaborator
• Ospedale Fra Castoro- San Bonifacio (Verona), Italy: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (4)

Mater Salutis Hospital

Legnago, Verona, 37045, Italy

Location

Fracastoro Hospital

San Bonifacio, Verona, 37047, Italy

Location

University Hospital of Verona (AOUI), Verona, Italy

Verona, Verona, 37100, Italy

Location

San Bortolo Hospital

Vicenza, Vicenza, 36100, Italy

Location

Related Publications (4)

• 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.

  PMID: 19594526 BACKGROUND

• 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.

  PMID: 19594530 BACKGROUND

• 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.

  PMID: 10428004 BACKGROUND

• 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.

  PMID: 19419233 BACKGROUND

Study Officials

• Giampaolo Velo, Medicine and Surgery

  The University of Verona, Verona , Italy

  STUDY DIRECTOR

Central Study Contacts

Lara Magro, Chemistry and pharm. technol.

CONTACT

0039 045/8027147; lara.magro@univr.it

Ermelinda Viola, Chemistry and pharm. technol.

CONTACT

0039 045/8124904; ermelinda.viola@univr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Pharmacology and Director of the Clinical Pharmacology Unit, Verona, Italy

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

IT (4)