Vascular Disease
Conditions
Brief summary
To design, validate and prove cost-effectiveness of a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs.
Detailed description
The main goal is to design a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in the iliac, superficial femoral and popliteal arteries). The curriculum will consist of E-learning, video-based learning and simulation exercises on the Virtual Reality simulator on which an endovascular procedure will be simulated. Skills transferability to real life practice will be verified by means of a RCT. In this RCT the investigators will compare the cognitive knowledge and technical performance of curricular trained surgical trainees with conventionally trained trainees during treatment of patients under supervision. The hypothesis states that surgeons trained within the PROSPECT curriculum will show improved technical knowledge of endovascular treatment of atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will demonstrate increased technical proficiency in the angiosuite in comparison with surgeons who received only conventional training. Subjects will be surgical trainees (N=32). They will be randomized into a three groups: a control group (N=11), a group that only has access to E-learning (N=10) and a PROSPECT group (N=11). Both groups will continue their traditional clinical education and the PROSPECT group will additionally be trained within this endovascular curriculum. The investigators hope that this study may ultimately lead to an improvement in the quality of patient care by standardizing competencies of endovascular operators in training and practice. Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training modalities will be executed. A successful training program is expected to lead to a shortening of the learning curve, reduction in number of errors during real life procedures and more efficient use of hybrid angio suites. The financial impact of potentially shorter duration of endovascular interventions will be studied and compared to time investment and additional costs associated with stepwise, supervised training using VR simulators.
Interventions
OTHERadditional curriculum (E-learning + simulation)
OTHERadditional E-learning
Sponsors
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Initially 39 participants were enrolled, 7 excluded because they declined to participate. 32 people were randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Surgical trainee * Knowledge and technical skill level evaluated * Demographics questionnaire and general MCQ test completed * 2 endovascular simulated exercises completed after familiarization with the simulator
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical and Global Performance of the Surgical Trainee in Real Life Procedures | 6 weeks after intervention | The consultant will assess the trainee during the intervention. * Global Rating Scale of Endovascular Performance (Range 11-55): to rate the global performance - modified OSATS (Objective Structured Assessment of Technical Skills) scale * Examiner Checklist for Diagnostic Angiography, Angioplasty and Stenting (Range 17-85): to rate the technical performance For both scales, the higher the score, the better. Surrogate measures of performance are also evaluated (total procedure and fluoroscopy time, radiation dose, contrast volume and number of endovascular tools used). Post-hoc videos of hand movements and the fluoroscopy imaging recorded during the real procedure will be rated using the same scoring systems. Two real life endovascular procedures will be performed within six weeks after completing the curriculum. Evaluation will occur during the intervention and videos of hand movements and fluoroscopy imaging will be evaluated afterwards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre curriculum, 6 weeks and 3 months after completion of the curriculum (3 months only for intervention arms) | The cognitive and technical skills retention of the surgical trainee is measured by a MCQ test and a simulation based exercise, pre and post PROSPECT. MCQ test: validated Multiple Choice Test - Range 0-20 GRS: Global Rating Scale of Endovascular Performance, modified OSATS (Objective Structured Assessment of Technical Skills) scale: to assess global performance (same as primary outcome) - Range: 11-55 Examiners checklist: Examiner Checklist for Diagnostic Angiography, Angioplasty and Stenting: to assess technical performance (same as primary objective) - Range: 17-85 For al outcome measures: the higher the score, the better |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROSPECT Proficiency | After RCT | After the RCT, a registry was started with all participants that started PROSPECT. Outcome: do PROSPECT participants pass the curriculum, do they become proficient? |
Countries
Belgium
Participant flow
Recruitment details
Recruitment for RCT (before 02/2016): general surgery trainees from Ghent University Recruitment for registry (after 02/2016): general surgery trainees from Ghent University, Leuven University, Nancy University, Lille University, CAMES Copenhagen
Pre-assignment details
7 people declined to participate before randomisation during the RCT
Participants by arm
| Arm | Count |
|---|---|
| PROSPECT the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator.
additional curriculum | 11 |
| E-LEARNING the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises. | 10 |
| CONTROL The trainee will continue clinical education without additional curriculum, but will be allowed to study independently. | 11 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Logistics | 1 | 0 | 0 |
| Overall Study | Pregnancy | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | PROSPECT | E-LEARNING | CONTROL | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 11 Participants | 32 Participants |
| No. endovascular cases assisted 0-5 | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| No. endovascular cases assisted 100-200 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| No. endovascular cases assisted 10-50 | 6 Participants | 5 Participants | 1 Participants | 12 Participants |
| No. endovascular cases assisted > 200 | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| No. endovascular cases assisted 50-100 | 1 Participants | 1 Participants | 5 Participants | 7 Participants |
| No. endovascular cases assisted 5-10 | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Postgraduate year Level 1 | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Postgraduate year Level 2 | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Postgraduate year Level 3 | 4 Participants | 1 Participants | 3 Participants | 8 Participants |
| Postgraduate year Level 4 | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Postgraduate year Level 5 | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Postgraduate year Level 6 | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 11 |
Outcome results
Primary
Technical and Global Performance of the Surgical Trainee in Real Life Procedures
The consultant will assess the trainee during the intervention. * Global Rating Scale of Endovascular Performance (Range 11-55): to rate the global performance - modified OSATS (Objective Structured Assessment of Technical Skills) scale * Examiner Checklist for Diagnostic Angiography, Angioplasty and Stenting (Range 17-85): to rate the technical performance For both scales, the higher the score, the better. Surrogate measures of performance are also evaluated (total procedure and fluoroscopy time, radiation dose, contrast volume and number of endovascular tools used). Post-hoc videos of hand movements and the fluoroscopy imaging recorded during the real procedure will be rated using the same scoring systems. Two real life endovascular procedures will be performed within six weeks after completing the curriculum. Evaluation will occur during the intervention and videos of hand movements and fluoroscopy imaging will be evaluated afterwards.
Time frame: 6 weeks after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROSPECT | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | GRS (real life simulation) | 39.36 score on a scale | Standard Deviation 2.05 |
| PROSPECT | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | Checklist (real life simulation) | 63.51 score on a scale | Standard Deviation 3.18 |
| E-LEARNING | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | GRS (real life simulation) | 28.42 score on a scale | Standard Deviation 2.15 |
| E-LEARNING | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | Checklist (real life simulation) | 53.63 score on a scale | Standard Deviation 3.34 |
| CONTROL | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | GRS (real life simulation) | 23.09 score on a scale | Standard Deviation 2.18 |
| CONTROL | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | Checklist (real life simulation) | 38.72 score on a scale | Standard Deviation 3.38 |
Secondary
Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module
The cognitive and technical skills retention of the surgical trainee is measured by a MCQ test and a simulation based exercise, pre and post PROSPECT. MCQ test: validated Multiple Choice Test - Range 0-20 GRS: Global Rating Scale of Endovascular Performance, modified OSATS (Objective Structured Assessment of Technical Skills) scale: to assess global performance (same as primary outcome) - Range: 11-55 Examiners checklist: Examiner Checklist for Diagnostic Angiography, Angioplasty and Stenting: to assess technical performance (same as primary objective) - Range: 17-85 For al outcome measures: the higher the score, the better
Time frame: Pre curriculum, 6 weeks and 3 months after completion of the curriculum (3 months only for intervention arms)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post test MCQ 6w | 18.11 score on a test or scale | Standard Deviation 1.36 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre-test MCQ | 14 score on a test or scale | Standard Deviation 3.39 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post test MCQ 3m | 18.25 score on a test or scale | Standard Deviation 1.98 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre GRS | 19.78 score on a test or scale | Standard Deviation 7.24 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post GRS 6w | 49.56 score on a test or scale | Standard Deviation 3.78 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post GRS 3m | 51.13 score on a test or scale | Standard Deviation 3.44 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre Examiner Checklist | 43.56 score on a test or scale | Standard Deviation 15.76 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post Examiner Checklist 6w | 83.22 score on a test or scale | Standard Deviation 1.99 |
| PROSPECT | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post Examiner Checklist 3m | 82.25 score on a test or scale | Standard Deviation 1.75 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post Examiner Checklist 3m | 51.71 score on a test or scale | Standard Deviation 16.31 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post GRS 6w | 32.75 score on a test or scale | Standard Deviation 13.51 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre GRS | 16.25 score on a test or scale | Standard Deviation 4.1 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre-test MCQ | 14.88 score on a test or scale | Standard Deviation 1.13 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post Examiner Checklist 6w | 59.25 score on a test or scale | Standard Deviation 16.73 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post test MCQ 6w | 17.88 score on a test or scale | Standard Deviation 0.99 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post GRS 3m | 24.14 score on a test or scale | Standard Deviation 6.65 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre Examiner Checklist | 35.63 score on a test or scale | Standard Deviation 11.38 |
| E-LEARNING | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post test MCQ 3m | 17.71 score on a test or scale | Standard Deviation 0.75 |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post GRS 3m | NA score on a test or scale | — |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre Examiner Checklist | 37.6 score on a test or scale | Standard Deviation 13.98 |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre GRS | 18 score on a test or scale | Standard Deviation 7.75 |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post GRS 6w | 21.2 score on a test or scale | Standard Deviation 7.48 |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post test MCQ 3m | NA score on a test or scale | — |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post Examiner Checklist 6w | 42.8 score on a test or scale | Standard Deviation 15.39 |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post Examiner Checklist 3m | NA score on a test or scale | — |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Pre-test MCQ | 14 score on a test or scale | Standard Deviation 2.49 |
| CONTROL | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | Post test MCQ 6w | 15.2 score on a test or scale | Standard Deviation 2.7 |
Comparison: Prior to the study a power analysis was performed to calculate the number of participants required in each of the three groups. Previous work comparing OSATS derived scores in endovascular interventions shows a Cohen D of two. Using a of .05, a power of .80, and an expected dropout rate of 10%, the minimum number of surgical trainees required per group was seven.~Null hypothesis for primary outcome: no difference in technical performance during real life procedures between the three groupsp-value: 0.001ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test MCQ scorep-value: 0.003ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test MCQ scorep-value: 0.001ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test MCQ scorep-value: 0.228ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test GRS scorep-value: 0.001ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test GRS scorep-value: 0.008ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test GRS scorep-value: 0.164ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist scorep-value: 0.001ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist scorep-value: 0.001ANOVA
Comparison: Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist scorep-value: 0.19ANOVA
Other Pre-specified
PROSPECT Proficiency
After the RCT, a registry was started with all participants that started PROSPECT. Outcome: do PROSPECT participants pass the curriculum, do they become proficient?
Time frame: After RCT