KnowledgeNCT06366607
Managing High-alert Medication Administration and Errors
An observational study of Knowledge and Practice Nurse's Scope, run by Matrouh University at 1 site in Egypt.
Trial summary
High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knowledge, Practice Nurse's Scope, Competence
- What is being tested?
- high-alert medication administration
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 31 May 2023
- 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: A sample of 300 nurses was enrolled in the current study. The nurses were willing to participate in the study and provided their agreement by informed consent.
Who may be able to join
- Nurses
- willing to participate in the study
- work in surgical intensive and critical care units
- Sign a consent
Who cannot join
- Nurses
- Work in outpatient units and other units
- Did not sign a consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Safety Climate: Managing High-alert Medication Administration and Errors Among Nurses in Intensive and Critical Care Units
High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff.
Read the detailed description
High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. This study aims to investigate the relationships between medication safety climate and nurses' knowledge about high-alert medications with managing their administration and errors.
- Conditions
- Knowledge, Practice Nurse's Scope, Competence, Nurse's Role, Error Disclosure
- Being tested
- high-alert medication administration
- Keywords
- Medication safety climate, Managing, High-alert medication, Administration, Errors, Nurses' role
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-alert medication administrationOther
high-alert medication administration
| Study group | Role | What they receive |
|---|---|---|
| nurses | Nurses worked in surgical intensive and critical care units Receives: Other: high-alert medication administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to measure nurses' knowledge about high-alert medication administration
Nurses' knowledge about high-alert medication administration as assessed binary scale.
Measured: one month
Questionnaire to measure medication safety climate
Medication safety climate as assessed using five-point Likert scale ranging from strongly disagree (1 point) to strongly agree (5 points).
Measured: one month
Questionnaire to measure nurses' competency
Nurses' competency during the administration of high-alert medications as assessed using five- Likert scales ((0 = not appropriate at all in administering high-alert medications up to 4 = very often appropriate in administering high-alert medications)
Measured: one month
observational check list to measure nurses' practice during administration of high-alert medications
Observing nurses' practice during the administration of high alert medications as assessed using five Likert scales (0=inappropriate practice up to 4=appropriate practice)
Measured: one month
Questionnaire to measure errors associated with administering high-alert medications
Errors associated with administering high-alert medications as assessed using a binary scale ( Yes=1 , No=0)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KnowledgeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matrouh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagah Abd El-Fattah Mohamed Aly, Matrouh University
- Investigators
- Nagah Abd El-Fattah Mohamed Aly, Ph.D, Principal investigator, Faculty of Nursing, Matrouh University, EgyptWael M. Lotfy, Ph.D, Study director, Faculty of Nursing, Matrouh University, EgyptSafaa M. El-Shanawany, Ph.D, Study chair, Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, EgyptMaha Ghanem, Ph.D, Study chair, Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, EgyptHanaa Abbass, Ph.D, Principal investigator, Psychatric Nursing and Mental health , Faculty of Nursing, Alexandria University, EgyptMaysa Elbiaa, Ph.D, Principal investigator, Faculty of Nursing, Matrouh University , Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366607
- Sponsor's protocol ID
- 0306066
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Safety Climate: Managing High-alert Medication Administration and Errors Among Nurses in Intensive and Critical Care Units
- ClinicalTrials.gov ID
- NCT06366607
- Acronym / sponsor ID
- 0306066
- Conditions
- Knowledge, Practice Nurse's Scope, Competence, Nurse's Role, Error Disclosure
- Keywords
- Medication safety climate, Managing, High-alert medication, Administration, Errors, Nurses' role
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Matrouh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 16 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.
High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff.
Detailed description
High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. This study aims to investigate the relationships between medication safety climate and nurses' knowledge about high-alert medications with managing their administration and errors.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nurses | – | Other: high-alert medication administrationNurses worked in surgical intensive and critical care units |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A sample of 300 nurses was enrolled in the current study. The nurses were willing to participate in the study and provided their agreement by informed consent.
Key inclusion criteria (4 listed)
- Nurses
Key exclusion criteria (3 listed)
- Nurses
- Work in outpatient units and other units
- Did not sign a 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 |
|---|---|---|
| high-alert medication administrationhigh-alert medication administration | Other | nurses |
Primary outcome
Questionnaire to measure nurses' knowledge about high-alert medication administration
Time frame: one month
Nurses' knowledge about high-alert medication administration as assessed binary scale.
Questionnaire to measure medication safety climate
Time frame: one month
Medication safety climate as assessed using five-point Likert scale ranging from strongly disagree (1 point) to strongly agree (5 points).
Questionnaire to measure nurses' competency
Time frame: one month
Nurses' competency during the administration of high-alert medications as assessed using five- Likert scales ((0 = not appropriate at all in administering high-alert medications up to 4 = very often appropriate in administering high-alert medications)
observational check list to measure nurses' practice during administration of high-alert medications
Time frame: one month
Observing nurses' practice during the administration of high alert medications as assessed using five Likert scales (0=inappropriate practice up to 4=appropriate practice)
Questionnaire to measure errors associated with administering high-alert medications
Time frame: one month
Errors associated with administering high-alert medications as assessed using a binary scale ( Yes=1 , No=0)
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 16 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Nagah Abd El-Fattah Mohamed Aly, Ph.D principal investigator
Faculty of Nursing, Matrouh University, Egypt
Wael M. Lotfy, Ph.D study director
Faculty of Nursing, Matrouh University, Egypt
Safaa M. El-Shanawany, Ph.D study chair
Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
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 Knowledge and Practice Nurse's Scope, run by Matrouh University at 1 site in Egypt.
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 4 inclusion and 3 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 16 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 Egypt. 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?
Questionnaire to measure nurses' knowledge about high-alert medication administration (time frame: one month). The study lists 5 primary outcomes in all. 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 16 Apr 2024.