Patient SafetyNCT07844369
Patient Safety Competency-Building Program for Healthcare Professionals in Pediatric Cardiac Critical Care in Ethiopia
A study testing Patient Safety Competency-Building Program in people with Patient Safety and Patient Safety Education, run by Woong-Han Kim at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Patient Safety Education
- What is being tested?
- Patient Safety Competency-Building Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteEthiopia
- Study dates
- 7 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Patient Safety Competency-Building Program for Healthcare Professionals in Pediatric Cardiac Critical Care in Ethiopia
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.
- Conditions
- Patient Safety, Patient Safety Education
- Being tested
- Patient Safety Competency-Building Program
- Keywords
- patient safety competence, healthcare professionals, patient safety education, low- and middle-income countries, pediatric cardiac critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Safety Competency-Building ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient Safety Competency-Building Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and immediately after the first training round
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start7 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woong-Han Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Woong-Han Kim, Seoul National University Hospital
- Investigators
- Woong-Han Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844369
- Sponsor's protocol ID
- H-2607-045-1764
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Patient Safety Competency-Building Program for Healthcare Professionals in Pediatric Cardiac Critical Care in Ethiopia
- ClinicalTrials.gov ID
- NCT07844369
- Acronym / sponsor ID
- H-2607-045-1764
- Conditions
- Patient Safety, Patient Safety Education
- Keywords
- patient safety competence, healthcare professionals, patient safety education, low- and middle-income countries, pediatric cardiac critical care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Woong-Han KimUniversity, hospital or other
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Sep 2026 (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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient Safety Competency-Building Program | Experimental | Behavioral: Patient Safety Competency-Building ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Patient Safety Competency-Building ProgramThe 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. | Behavioural | Patient Safety Competency-Building Program |
Primary outcome
Patient Safety Competence
Time frame: Before and immediately after each training round
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.
1 secondary outcome
Medication Safety Competence
Time frame: Before and immediately after the first training round
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Patient Safety
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
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.
Woong-Han Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Safety Competency-Building Program in people with Patient Safety and Patient Safety Education, run by Woong-Han Kim at 1 site in Ethiopia.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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 Ethiopia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Safety Competence (time frame: Before and immediately after each training round). 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 1 Oct 2026.