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Active, not recruitingNCT07844369Updated Oct 1, 2026

Patient Safety Competency-Building Program for Healthcare Professionals in Pediatric Cardiac Critical Care in Ethiopia

An interventional study of Patient Safety Competency-Building Program in Patient Safety and Patient Safety Education, sponsored by Woong-Han Kim. Active, not recruiting at 1 site in Ethiopia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Woong-Han Kim · Not applicable, Interventional, and Health services research

Updated Oct 1, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to develop and evaluate a patient safety competency-building program for healthcare professionals involved in pediatric cardiac critical care in Ethiopia. The program consists of educational modules addressing key areas of patient safety and is delivered in person at a tertiary hospital in Addis Ababa, Ethiopia. Patient safety competence is assessed before and immediately after each training round, and acceptability, appropriateness, and feasibility are assessed immediately after each training round as implementation outcomes.

Read the detailed description

The patient safety competency-building program comprises nine educational modules delivered across three training rounds, with selected modules provided during each round. Healthcare professionals involved in pediatric cardiac critical care may participate in one or more training rounds, and participants may therefore differ across rounds. For each training round, patient safety competence is assessed before the training and immediately after its completion as a common educational outcome. Medication safety competence is assessed before and immediately after the first training round as a round-specific educational outcome. Acceptability, appropriateness, and feasibility are assessed immediately after each training round as implementation outcomes.

02

Conditions studied

  • Patient Safety
  • Patient Safety Education

Keywords

  • patient safety competence
  • healthcare professionals
  • patient safety education
  • low- and middle-income countries
  • pediatric cardiac critical care
03

In context

Lead sponsor

This is the only study on the registry with Woong-Han Kim as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthcare professionals involved in pediatric cardiac critical care at Tikur Anbessa Specialized Hospital, including physicians, nurses, perfusionists, and other relevant healthcare professionals
  • Able to understand the purpose and procedures of the study and voluntarily provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Healthcare professionals who are on leave or are not directly involved in pediatric cardiac critical care at the time of the study
  • Individuals who are unable to adequately understand or participate in the educational program conducted in English, even with Amharic language support
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (estimated)

Study arms

  • Experimental
    Patient Safety Competency-Building Program

    Participants receive a patient safety competency-building program designed for healthcare professionals involved in pediatric cardiac critical care. The program comprises nine educational modules and is delivered in person across three training rounds, with selected patient safety modules provided during each round.

    Behavioral: Patient Safety Competency-Building Program

Interventions

  • BehavioralPatient Safety Competency-Building Program

    The patient safety competency-building program consists of nine educational modules: Patient Safety Principles; Teamwork and Communication; Surgical Safety; Medication Safety; Blood Transfusion Safety; Infection Control; Patient Assessment and Clinical Decision-Making; Safety Equipment Management; and Patient Safety Incident Response and Reporting. Selected modules are delivered during each training round through in-person lectures, group discussions, and practical activities.

06

What researchers measure

Primary outcomes

  1. Patient Safety Competence

    Patient safety competence is measured using the Health Professional Education in Patient Safety Survey (H-PEPSS), a 16-item self-report instrument covering six domains: working in teams with other health professionals, communicating effectively, managing safety risks, understanding human and environmental factors, recognizing and responding to adverse events, and culture of safety. Scores are calculated as the mean of the 16 items, with possible scores ranging from 1 to 5; higher scores indicate greater perceived patient safety competence.

    Time frame: Before and immediately after each training round

Secondary outcomes

  1. Medication Safety Competence

    Medication safety competence is measured using the Medication Safety Competence Scale (MSCS), a 36-item self-report instrument covering six domains: patient-centered medication management, improvement of safety problems, management of effecting factors, safety risk management, multidisciplinary collaboration, and responsibility in the nursing profession. Scores are calculated as the mean of the 36 items, with possible scores ranging from 1 to 5; higher scores indicate greater medication safety competence.

    Time frame: Before and immediately after the first training round

Other outcomes

  1. Acceptability of the Intervention

    Acceptability is measured using the Acceptability of Intervention Measure (AIM). The AIM consists of four items rated on a 5-point Likert scale. Scores are calculated as the mean of the four items, ranging from 1 to 5; higher scores indicate greater acceptability of the intervention.

    Time frame: Immediately after each training round

  2. Appropriateness of the Intervention

    Appropriateness is measured using the Intervention Appropriateness Measure (IAM). The IAM consists of four items rated on a 5-point Likert scale. Scores are calculated as the mean of the four items, ranging from 1 to 5; higher scores indicate greater perceived appropriateness of the intervention.

    Time frame: Immediately after each training round

  3. Feasibility of the Intervention

    Feasibility is measured using the Feasibility of Intervention Measure (FIM). The FIM consists of four items rated on a 5-point Likert scale. Scores are calculated as the mean of the four items, ranging from 1 to 5; higher scores indicate greater perceived feasibility of the intervention.

    Time frame: Immediately after each training round

  4. Program Satisfaction

    Program satisfaction is assessed using a questionnaire developed by the research team. The questionnaire includes 5-point ratings of overall satisfaction, individual educational sessions, and five aspects of the educational experience, as well as a 10-point rating of achievement of the program objectives. Higher scores indicate more favorable evaluations. Open-ended questions are included to obtain additional participant feedback.

    Time frame: Immediately after each training round

07

Study locations

1 site
  • Tikur Anbessa Specialized Hospital
    Addis Ababa, Addis Ababa, Ethiopia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
eligibility
Registered
First appeared on the registry
Sep 28, 2026
Show all 2 updates
  1. Oct 1, 2026
    Eligibility Criteria revised
    + 4 other changes: identifiers, description, secondary outcomes and contact details
  2. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07844369
Lead sponsor
Woong-Han Kim
Responsible party
Woong-Han Kim (Professor, Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University Hospital) — Sponsor-investigator
First posted
Sep 28, 2026
Start date
Aug 7, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Woong-Han Kim, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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