- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521101
Can we Make a VAST Improvement? Promoting Anaesthetists' Non-technical Skills Through the Vital Anaesthesia Simulation Training Course in a Low-resource Setting
Rationale: The World Health Assembly resolution 68.15 identified surgical and anesthesia care as core components of universal health coverage. However, about 5 billion people worldwide lack access to essential surgical and anesthesia services. Of the 313 million procedures undertaken each year only 6% occur in the poorest countries with an estimated 30% of all deaths globally associated with common surgical conditions. Patient safety in low-resource settings is hindered by severe workforce shortages, lack of essential resources, hierarchical culture and few opportunities for professional development.
Non-technical skills (NTS), such as communication, team working, and task coordination, are vital to patient safety. Up to 70-80% of untoward events in health care are associated with errors in NTS8. The Anaesthetists' Non-Technical Skills framework (ANTS) describes behaviour markers for NTS in anesthesia. This framework has been found applicable in low-resource settings.
Simulation-based education is widespread for NTS training in well-resourced countries. Traditionally, high costs have prohibited this modality in low-resource settings. Foundational work in Rwanda and at Dalhousie University has demonstrated that effective training in ANTS can be achieved through simple low-cost simulation. The Vital Anaesthesia Simulation Training (VAST) Course is a three-day simulation-based program designed de-novo to focus on core clinical practices and NTS that promote safe perioperative care in low-resource settings. The course uses low-cost materials in an immersive simulated environment to replicate common cases managed in district hospitals in low-resource settings. Realism is created with simple mannequins, iPads with the SimMon App functioning as monitoring, basic props (e.g., airway equipment, syringes, drapes), photographs of pathology, and briefing cards for scenario role-play.
Purpose: To assess the impact of the VAST Course on ANTS and explore factors that influence long-term retention of ANTS amongst anesthesia providers in a low-resource setting.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Butare, Rwanda
- University of Rwanda
-
Kigali, Rwanda
- Rwanda Military Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All anesthesia (anesthesiologists, anesthesia residents and non-physician anesthetists) VAST Course participants during the study period.
Exclusion Criteria:
- VAST Course participants who do not practice anesthesia (surgeons, nurses, midwives etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: VAST Course
|
Educational course to teach non-technical skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Anesthesia NonTechnical Skills (ANTS) Score
Time Frame: Day 1 (pre-course test)
|
Baseline ANTS Score
|
Day 1 (pre-course test)
|
Total Anesthesia NonTechnical Skills (ANTS) Score
Time Frame: Day 3 (post-course test)
|
The change from baseline ANTS score to post-course (day 3)
|
Day 3 (post-course test)
|
Total Anesthesia NonTechnical Skills (ANTS) Score
Time Frame: 4 months (follow-up score)
|
The change from baseline ANTS score to follow-up (4 months)
|
4 months (follow-up score)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Category Anesthesia NonTechnical Skills (ANTS) Score
Time Frame: Day 1 (pre-course)
|
Baseline category ANTS scores (team working, task management, situation awareness, decision making)
|
Day 1 (pre-course)
|
Category Anesthesia NonTechnical Skills (ANTS) Score
Time Frame: Day 3 (post-course)
|
The change in category ANTS scores (team working, task management, situation awareness, decision making)
|
Day 3 (post-course)
|
Category Anesthesia NonTechnical Skills (ANTS) Score
Time Frame: 4 months (post-course)
|
The change in category ANTS scores (team working, task management, situation awareness, decision making)
|
4 months (post-course)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-4474
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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