NCT06366607

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 3, 2024

Last Update Submit

April 13, 2024

Conditions

Keywords

Medication safety climateManaging, High-alert medicationAdministrationErrorsNurses' role

Outcome Measures

Primary Outcomes (5)

  • Questionnaire to measure nurses' knowledge about high-alert medication administration

    Nurses' knowledge about high-alert medication administration as assessed binary scale.

    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).

    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)

    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)

    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)

    one month

Study Arms (1)

nurses

Nurses worked in surgical intensive and critical care units

Other: high-alert medication administration

Interventions

high-alert medication administration

nurses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Nurses
  • willing to participate in the study
  • work in surgical intensive and critical care units
  • Sign a consent

You may not qualify if:

  • \- Nurses
  • Work in outpatient units and other units
  • Did not sign a consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Matrouh University

Marsá Maţrūḩ, 002, Egypt

Location

Study Officials

  • Nagah Abd El-Fattah Mohamed Aly, Ph.D

    Faculty of Nursing, Matrouh University, Egypt

    PRINCIPAL INVESTIGATOR
  • Wael M. Lotfy, Ph.D

    Faculty of Nursing, Matrouh University, Egypt

    STUDY DIRECTOR
  • 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

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Nursing administration

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 16, 2024

Study Start

March 1, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations