Observational Study to Reduce Medication Errors (OSME)
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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 |
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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 |
- 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 ]
- Number of participants with preventable ADRs due to medication errors [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- 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 |
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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
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All patients from 18 to 65 and over 65 years old hospitalized in the involved departments during the study period.
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| 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 |
| 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 | |
| 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:
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Medication errors, patients hospitalized, ADRs, adverse events |
Additional relevant MeSH terms:
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Drug Toxicity Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 22, 2013