NCT07844369

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress12%
Aug 2026Dec 2027

Study Start

First participant enrolled

August 7, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

September 21, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

patient safety competencehealthcare professionalspatient safety educationlow- and middle-income countriespediatric cardiac critical care

Outcome Measures

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.

    Before and immediately after each training round

Secondary Outcomes (1)

  • Medication Safety Competence

    Before and immediately after the first training round

Other Outcomes (4)

  • Acceptability of the Intervention

    Immediately after each training round

  • Appropriateness of the Intervention

    Immediately after each training round

  • Feasibility of the Intervention

    Immediately after each training round

  • +1 more other outcomes

Study Arms (1)

Patient Safety Competency-Building Program

EXPERIMENTAL

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

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.

Patient Safety Competency-Building Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tikur Anbessa Specialized Hospital

Addis Ababa, Addis Ababa, Ethiopia

Location

Study Officials

  • Woong-Han Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The study uses a single-group pretest-posttest design. The program is delivered across three training rounds, and participants may participate in one or more rounds and may differ across rounds. Outcomes are assessed before and immediately after the relevant training round.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 28, 2026

Study Start

August 7, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations