To Determine the Change in Demonstrated Anesthesia Non-technical Skills After Delivery of the VAST CourseNCT04521101
Can we Make a VAST Improvement? Promoting Anaesthetists' Non-technical Skills Through the Vital Anaesthesia Simulation Training Course in a Low-resource Setting
A study testing VAST Course in people with To Determine the Change in Demonstrated Anesthesia Non-technical Skills After Delivery of the VAST Course, run by Dalhousie University at 2 sites in Rwanda.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- To Determine the Change in Demonstrated Anesthesia Non-technical Skills After Delivery of the VAST Course
- What is being tested?
- VAST Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesRwanda
- Study dates
- 24 Aug 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All anesthesia (anesthesiologists, anesthesia residents and non-physician anesthetists) VAST Course participants during the study period.
Who cannot join
- VAST Course participants who do not practice anesthesia (surgeons, nurses, midwives etc.)
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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.
- Being tested
- VAST Course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAST CourseOther
Educational course to teach non-technical skills
| Study group | Role | What they receive |
|---|---|---|
| VAST Course | Other | Not described Receives: Other: VAST Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Anesthesia NonTechnical Skills (ANTS) Score
Baseline ANTS Score
Measured: Day 1 (pre-course test)
Total Anesthesia NonTechnical Skills (ANTS) Score
The change from baseline ANTS score to post-course (day 3)
Measured: Day 3 (post-course test)
Total Anesthesia NonTechnical Skills (ANTS) Score
The change from baseline ANTS score to follow-up (4 months)
Measured: 4 months (follow-up score)
Secondary outcomes (3)
Category Anesthesia NonTechnical Skills (ANTS) Score
Baseline category ANTS scores (team working, task management, situation awareness, decision making)
Measured: Day 1 (pre-course)
Category Anesthesia NonTechnical Skills (ANTS) Score
The change in category ANTS scores (team working, task management, situation awareness, decision making)
Measured: Day 3 (post-course)
Category Anesthesia NonTechnical Skills (ANTS) Score
The change in category ANTS scores (team working, task management, situation awareness, decision making)
Measured: 4 months (post-course)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start24 Aug 2018
- Primary completion30 Jan 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Change in Demonstrated Anesthesia Non-technical Skills After Delivery of the VAST CourseStudies 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Livingston, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521101
- Sponsor's protocol ID
- 2018-4474
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2019
- Last updated
- 21 Aug 2020
- 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 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Make a VAST Improvement? Promoting Anaesthetists' Non-technical Skills Through the Vital Anaesthesia Simulation Training Course in a Low-resource Setting
- ClinicalTrials.gov ID
- NCT04521101
- Acronym / sponsor ID
- 2018-4474
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Aug 2020 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAST Course | Other | Other: VAST Course |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All anesthesia (anesthesiologists, anesthesia residents and non-physician anesthetists) VAST Course participants during the study period.
Key exclusion criteria (1 listed)
- VAST Course participants who do not practice anesthesia (surgeons, nurses, midwives etc.)
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 |
|---|---|---|
| VAST CourseEducational course to teach non-technical skills | Other | VAST Course |
Primary outcome
Total Anesthesia NonTechnical Skills (ANTS) Score
Time frame: Day 1 (pre-course test)
Baseline ANTS Score
Total Anesthesia NonTechnical Skills (ANTS) Score
Time frame: Day 3 (post-course test)
The change from baseline ANTS score to post-course (day 3)
Total Anesthesia NonTechnical Skills (ANTS) Score
Time frame: 4 months (follow-up score)
The change from baseline ANTS score to follow-up (4 months)
3 secondary outcomes
Category Anesthesia NonTechnical Skills (ANTS) Score
Time frame: Day 1 (pre-course)
Category Anesthesia NonTechnical Skills (ANTS) Score
Time frame: Day 3 (post-course)
Category Anesthesia NonTechnical Skills (ANTS) Score
Time frame: 4 months (post-course)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAST Course in people with To Determine the Change in Demonstrated Anesthesia Non-technical Skills After Delivery of the VAST Course, run by Dalhousie University at 2 sites in Rwanda.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Anesthesia NonTechnical Skills (ANTS) Score (time frame: Day 1 (pre-course test)). The study lists 3 primary outcomes in all. 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 21 Aug 2020.