Medication ErrorsOSMENCT01734642
Observational Study to Reduce Medication Errors
An observational study of Medication Errors, run by Universita di Verona at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Errors
- How many people
- 8,000 participants
- Where
- 4 sitesItaly
- Study dates
- Jan 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients from 18 to 65 and over 65 years old hospitalized in the involved departments during the study period.
Who may be able to join
- 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.
Who cannot join
- all patients with evident mental and physical problems and all patients who did not give their informed consent.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Mater Salutis Hospital
Legnago, Verona, 37045
Giampaolo Velo, medicine, 0039 045/8127450, giampaolo.velo@univr.it
Lara Magro, pharmacy, 0039 045/8027147, lara.magro@univr.it
Fracastoro Hospital
San Bonifacio, Verona, 37047
Giampaolo Velo, Medicine, 0039 045/8127450, giampaolo.velo@univr.it
Ermelinda Viola, pharmacy, 0039 045/8124904, ermelinda.viola@univr.it
University Hospital of Verona (AOUI), Verona, Italy
Verona, Verona, 37100
Giampaolo Velo, Medicine, 0039 045/8127450, giampaolo.velo@univr.it
Lara Magro, pharmacy, 0039 045/8027147, lara.magro@univr.it
San Bortolo Hospital
Vicenza, Vicenza, 36100
Giampaolo Velo, Medicine, 0039 045/8127450, giampaolo.velo@univr.it
Ermelinda Viola, Pharmacy, 0039 045/8124904, ermelinda.viola@univr.it
About this study
Official title: A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse drug reactions due to medication errors occurring during hospitalization
Measured: within the first 3 months
Secondary outcomes (1)
Number of participants with preventable ADRs due to medication errors
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medication ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale S.Bortolo -Vicenza, Italy, Ospedale Mater Salutis-Legnago(Verona), Italy, Ospedale Fra Castoro- San Bonifacio (Verona), Italy, Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Principal investigator, GIAMPAOLO VELO, Universita di Verona
- Investigators
- Giampaolo Velo, Medicine and Surgery, Study director, The University of Verona, Verona , Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734642
- Sponsor's protocol ID
- 31025
- Acronym
- OSME
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19594526Velo 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.
PubMed 19594530Bates 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.
PubMed 10428004Lewis 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.
PubMed 19419233
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital
- ClinicalTrials.gov ID
- NCT01734642
- Acronym / sponsor ID
- OSME / 31025
- Conditions
- Medication Errors
- Keywords
- Medication errors, patients hospitalized, ADRs, adverse events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Ospedale S.Bortolo -Vicenza, Italy, Ospedale Mater Salutis-Legnago(Verona), Italy, Ospedale Fra Castoro- San Bonifacio (Verona), Italy, Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients from 18 to 65 and over 65 years old hospitalized in the involved departments during the study period.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- all patients with evident mental and physical problems and all patients who did not give their informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse drug reactions due to medication errors occurring during hospitalization
Time frame: within the first 3 months
1 secondary outcome
Number of participants with preventable ADRs due to medication errors
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
- Background: PubMed 19594526Aronson 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.
- Background: PubMed 19594530Velo 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.
- Background: PubMed 10428004Bates 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.
- Background: PubMed 19419233Lewis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giampaolo Velo, Medicine and Surgery study director
The University of Verona, Verona , Italy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Errors, run by Universita di Verona at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Magro, Chemistry and pharm. technol. (0039 045/8027147, lara.magro@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse drug reactions due to medication errors occurring during hospitalization (time frame: within the first 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734642, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.