Medication Errors and Other Product Use Errors and IssuesSAPHET-iNCT04193839
Reducing Errors In The Neonatal Intensive Care Unit
An observational study of Medication Errors and Other Product Use Errors and Issues and Adverse Drug Event, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU) Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Medication Errors and Other Product Use Errors and Issues, Adverse Drug Event
- What is being tested?
- Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 1 Jun 2021
- How long will I take part?
- 1 Month
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Any patient admitted to the NICU who needs pharmacological intervention is eligible.
Who may be able to join
- Admission to the NICU
- Need of pharmacological intervention
- Informed parental consent
Who cannot join
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
Maria Pierro, MD, PhD, +39030351 ext. 8237, maria.pierro@poliambulanza.it
Maria Elena Vailati, +39030351 ext. 8022, elena.vailati@poliambulanza.it
About this study
Official title: Reducing Errors In The Neonatal Intensive Care Unit. The SAPHET-i Study: Secure, Automated, Functional, High-Tech Therapeutic Approach for iNFANTS
This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)
Read the detailed description
Medication errors are a burden to the health care system. The neonatal population, in particular the infants admitted to the NICU, are at higher risk of MEs as compared to the adult and pediatric population. Moreover adverse events (ADEs) occur more frequently and may be particularly severe in neonates.
Several strategies have been tried in order to decrease the incidence of MEs in the NICU. Among these, some studies investigated the effectiveness of CPOE in reducing MEs in hospitalised patients. However, results have been inconsistent. So far, no study investigated the association of CPOE + BCMA in neonates.
The investigators designed a monocentric prospective pre and post-intervention observational study to investigate the efficacy of the CPOE plus BCMA as compared to paper order entry in reducing MEs in the NICU population.
- Being tested
- Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)
- Keywords
- Computerized Provider Order entry, Patient safety, Quality improvement, Medication errors, Adverse events, Bar code medication administration, Neonates
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)Other
Computerized provider order entry (CPOE) refers to the process of providers entering and sending treatment instructions - including medication, laboratory, and radiology orders - via a computer application rather than paper, fax, or telephone. The bar Code Medication Administration (BCMA) is a system that consists of a bar code reader, a portable or desktop computer with wireless connection, a computer server, and some software. Before the administration of medications to the patients the patient unique barcode identification is scanned in order to verify the patient's identity.
| Study group | Role | What they receive |
|---|---|---|
| Paper Order Entry cohort | Patients admitted to the NICU during the pre-intervention phase, enrolled in the study after parental consent. The medications prescribed to the patients enrolled during the pre-intervention period will be handled with the paper order entry | |
| CPOE + BCMA cohort | Patients admitted to the NICU during the post-intervention phase, enrolled in the study after parental consent. The medications prescribed to the patients enrolled during the post-intervention period will be handled with the Computerized Provider Order Entry + Bar Code Medication Administration (BCMA) Receives: Other: Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medication errors
The investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision
Measured: From date of NICU admission up to discharge, up to 18 months
Secondary outcomes (1)
Number of preventable adverse drug events
The investigators will record the number of preventable and non preventable adverse drug events
Measured: From date of NICU admission up to discharge, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Errors and Other Product Use Errors and IssuesStudies 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
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Pierro, Fondazione Poliambulanza Istituto Ospedaliero
- Investigators
- Maria Pierro, MD, PhD, Principal investigator, Fondazione Poliambulanza Istituto Ospedaliero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193839
- Sponsor's protocol ID
- NP 3751
- Acronym
- SAPHET-i
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Errors In The Neonatal Intensive Care Unit. The SAPHET-i Study: Secure, Automated, Functional, High-Tech Therapeutic Approach for iNFANTS
- ClinicalTrials.gov ID
- NCT04193839
- Acronym / sponsor ID
- SAPHET-i / NP 3751
- Keywords
- Computerized Provider Order entry, Patient safety, Quality improvement, Medication errors, Adverse events, Bar code medication administration, Neonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 10 Dec 2019 (actual)
- 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.
This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)
Detailed description
Medication errors are a burden to the health care system. The neonatal population, in particular the infants admitted to the NICU, are at higher risk of MEs as compared to the adult and pediatric population. Moreover adverse events (ADEs) occur more frequently and may be particularly severe in neonates.
Several strategies have been tried in order to decrease the incidence of MEs in the NICU. Among these, some studies investigated the effectiveness of CPOE in reducing MEs in hospitalised patients. However, results have been inconsistent. So far, no study investigated the association of CPOE + BCMA in neonates.
The investigators designed a monocentric prospective pre and post-intervention observational study to investigate the efficacy of the CPOE plus BCMA as compared to paper order entry in reducing MEs in the NICU population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper Order Entry cohort | – | –Patients admitted to the NICU during the pre-intervention phase, enrolled in the study after parental consent. The medications prescribed to the patients enrolled during the pre-intervention period will be handled with the paper order entry |
| CPOE + BCMA cohort | – | Other: Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)Patients admitted to the NICU during the post-intervention phase, enrolled in the study after parental consent. The medications prescribed to the patients enrolled during the post-intervention period will be handled with the Computerized Provider Order Entry + Bar Code Medication Administration (BCMA) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any patient admitted to the NICU who needs pharmacological intervention is eligible.
Key inclusion criteria (3 listed)
- Admission to the NICU
- Need of pharmacological intervention
- Informed parental consent
Key exclusion criteria (1 listed)
- Lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)Computerized provider order entry (CPOE) refers to the process of providers entering and sending treatment instructions - including medication, laboratory, and radiology orders - via a computer application rather than paper, fax, or telephone. The bar Code Medication Administration (BCMA) is a system that consists of a bar code reader, a portable or desktop computer with wireless connection, a computer server, and some software. Before the administration of medications to the patients the patient unique barcode identification is scanned in order to verify the patient's identity. | Other | CPOE + BCMA cohort |
Primary outcome
Number of medication errors
Time frame: From date of NICU admission up to discharge, up to 18 months
The investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision
1 secondary outcome
Number of preventable adverse drug events
Time frame: From date of NICU admission up to discharge, up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: Undecided
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.
Maria Pierro, MD, PhD principal investigator
Fondazione Poliambulanza Istituto Ospedaliero
1 site 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 and Other Product Use Errors and Issues and Adverse Drug Event, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site 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 3 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Maria Pierro, MD, PhD (+39030351 ext. 8987, maria.pierro@poliambulanza.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of medication errors (time frame: From date of NICU admission up to discharge, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2019.