- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06366607
Managing High-alert Medication Administration and Errors
April 13, 2024 updated by: Nagah Abd El-Fattah Mohamed Aly, Matrouh University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mersa Matruh, Egypt, 002
- Faculty of Nursing, Matrouh University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
Nurses
- willing to participate in the study
- work in surgical intensive and critical care units
- Sign a consent
Exclusion Criteria:
- Nurses
- Work in outpatient units and other units
- Did not sign a consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
nurses
Nurses worked in surgical intensive and critical care units
|
high-alert medication administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one month
|
|
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).
|
one month
|
|
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)
|
one month
|
|
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)
|
one month
|
|
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)
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Wael M. Lotfy, Ph.D, Faculty of Nursing, Matrouh University, Egypt
- Principal Investigator: Nagah Abd El-Fattah Mohamed Aly, Ph.D, Faculty of Nursing, Matrouh University, Egypt
- Study Chair: Safaa M. El-Shanawany, Ph.D, Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
- Study Chair: Maha Ghanem, Ph.D, Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
- Principal Investigator: Hanaa Abbass, Ph.D, Psychatric Nursing and Mental health , Faculty of Nursing, Alexandria University, Egypt
- Principal Investigator: Maysa Elbiaa, Ph.D, Faculty of Nursing, Matrouh University , Egypt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
April 3, 2024
First Submitted That Met QC Criteria
April 13, 2024
First Posted (Actual)
April 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 13, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0306066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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