Main Heading (Descriptor) TermsNCT06371690
The Effects of Using the Web-Based Double Eye Control Program on Medication Error
An observational study of Main Heading (Descriptor) Terms, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Main Heading (Descriptor) Terms
- Type of treatment
- Pill or oral medicine
- How many people
- 1,070 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 30 Sep 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of the research was composed of Nurses working in the Pediatric Surgery Department Clinic (Pediatric Surgery, Pediatric Surgery Intensive Care, Neonatal Surgery Intensive Care Clinics) of a university hospital in Turkey between November 2017 and June 2018, and all high-risk drugs they administered.
Who may be able to join
- The medications observed were to be in the high-risk drug group for children,
- Volunteering of nurses working in the clinic to participate in the research,
- Nurses working in the clinic should have had proper level of internet usage knowledge to use a web-based program.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Çi̇ğli̇, 35620
About this study
Official title: The Effects of Using the Web-Based Double Eye Control Program on Medication of High Risk Drugs in Pediatric Patients: The Effect of Web-Based Double Eye Control Program
Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study.
Read the detailed description
Background: In this study, it was aimed to examine the effect of using Web Based Double-Eye Control Program as a new decision support system in preventing errors and standardization in high-risk medications of pediatric nurses.
Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs (532 before the intervention, 538 after the intervention, a total of 1070 drug doses) administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study.
- Conditions
- Main Heading (Descriptor) Terms
- Being tested
- Web-Based Double-Eye Control Program
- Keywords
- Child, Child Nursing, High-Risk Drugs, Medication Error, Error Prevention Strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Double-Eye Control ProgramOther
Web-Based Double-Eye Control Program, a web-based drug dose calculation program, is compatible with smartphones, tablets and computers. On the interface of the website, the nurse is required to enter data such as the age, weight, medications and doses ordered by the physician of the patient. When all these data are entered, the amount of medication that the nurse should give and whether the ordered dose is within the safe dose range for the patient are calculated by the program, so that the nurse can control her own calculations. On the other interface of the website, there are medication instructions uploaded by the researchers. With this interface, nurses access all pharmacological information about especially high-risk drugs (indications, contraindications, interacting drugs and fluids, fluids to be used for diluting, medication route, medication pace, etc.) and information that will enable the medication to be carried out in a standard way.
| Study group | Role | What they receive |
|---|---|---|
| Medication errors during the application of high-risk drugs | Medication Errors During the Application of High-risk Drugs Before and After Using Web-Based Double-Eye Control Program Receives: Other: Web-Based Double-Eye Control Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error rates
Medication errors during administration of high-risk drugs in pediatric patients
Measured: Between January 2017 and September 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Nov 2017
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Main Heading (Descriptor) TermsStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Beste Ozguven Oztornaci, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371690
- Sponsor's protocol ID
- 17-11/37
- Status last verified
- Apr 2024
- First submitted
- 30 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using the Web-Based Double Eye Control Program on Medication of High Risk Drugs in Pediatric Patients: The Effect of Web-Based Double Eye Control Program
- ClinicalTrials.gov ID
- NCT06371690
- Acronym / sponsor ID
- 17-11/37
- Conditions
- Main Heading (Descriptor) Terms
- Keywords
- Child, Child Nursing, High-Risk Drugs, Medication Error, Error Prevention Strategies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 17 Apr 2024 (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.
Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study.
Detailed description
Background: In this study, it was aimed to examine the effect of using Web Based Double-Eye Control Program as a new decision support system in preventing errors and standardization in high-risk medications of pediatric nurses.
Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs (532 before the intervention, 538 after the intervention, a total of 1070 drug doses) administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication errors during the application of high-risk drugs | – | Other: Web-Based Double-Eye Control ProgramMedication Errors During the Application of High-risk Drugs Before and After Using Web-Based Double-Eye Control Program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of the research was composed of Nurses working in the Pediatric Surgery Department Clinic (Pediatric Surgery, Pediatric Surgery Intensive Care, Neonatal Surgery Intensive Care Clinics) of a university hospital in Turkey between November 2017 and June 2018, and all high-risk drugs they administered.
Key inclusion criteria (3 listed)
- The medications observed were to be in the high-risk drug group for children,
- Volunteering of nurses working in the clinic to participate in the research,
- Nurses working in the clinic should have had proper level of internet usage knowledge to use a web-based program.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Web-Based Double-Eye Control ProgramWeb-Based Double-Eye Control Program, a web-based drug dose calculation program, is compatible with smartphones, tablets and computers. On the interface of the website, the nurse is required to enter data such as the age, weight, medications and doses ordered by the physician of the patient. When all these data are entered, the amount of medication that the nurse should give and whether the ordered dose is within the safe dose range for the patient are calculated by the program, so that the nurse can control her own calculations. On the other interface of the website, there are medication instructions uploaded by the researchers. With this interface, nurses access all pharmacological information about especially high-risk drugs (indications, contraindications, interacting drugs and fluids, fluids to be used for diluting, medication route, medication pace, etc.) and information that will enable the medication to be carried out in a standard way. | Other | Medication errors during the application of high-risk drugs |
Primary outcome
Error rates
Time frame: Between January 2017 and September 2018
Medication errors during administration of high-risk drugs in pediatric patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Main Heading (Descriptor) Terms, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 17 Apr 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error rates (time frame: Between January 2017 and September 2018). 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 17 Apr 2024.