Trial Outcomes & Findings for Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees (NCT NCT01965860)
NCT ID: NCT01965860
Last Updated: 2021-03-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
6 weeks after intervention
Results posted on
2021-03-16
Participant Flow
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
7 people declined to participate before randomisation during the RCT
Participant milestones
| Measure |
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
|
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.
|
CONTROL
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
CONTROL
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
|
|---|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
1
|
|
Overall Study
Logistics
|
1
|
0
|
0
|
Baseline Characteristics
Row population differs from the overall as participants are spread accross study arms
Baseline characteristics by cohort
| Measure |
PROSPECT
n=11 Participants
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
|
E-LEARNING
n=10 Participants
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.
|
CONTROL
n=11 Participants
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
No. endovascular cases assisted
> 200
|
0 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
2 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Row population differs from overall as participants are spread accross study arms.
|
0 Participants
n=7 Participants • Row population differs from overall as participants are spread accross study arms.
|
0 Participants
n=5 Participants • Row population differs from overall as participants are spread accross study arms.
|
0 Participants
n=4 Participants • Row population differs from overall as participants are spread accross study arms.
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants • Row population differs from overall as participants are spread accross study arms.
|
10 Participants
n=7 Participants • Row population differs from overall as participants are spread accross study arms.
|
11 Participants
n=5 Participants • Row population differs from overall as participants are spread accross study arms.
|
32 Participants
n=4 Participants • Row population differs from overall as participants are spread accross study arms.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Row population differs from overall as participants are spread accross study arms.
|
0 Participants
n=7 Participants • Row population differs from overall as participants are spread accross study arms.
|
0 Participants
n=5 Participants • Row population differs from overall as participants are spread accross study arms.
|
0 Participants
n=4 Participants • Row population differs from overall as participants are spread accross study arms.
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms.
|
6 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms.
|
5 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms.
|
16 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms.
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms.
|
4 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms.
|
6 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms.
|
16 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms.
|
|
Postgraduate year
Level 1
|
2 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
4 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
9 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
Postgraduate year
Level 2
|
2 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
6 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
Postgraduate year
Level 3
|
4 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
8 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
Postgraduate year
Level 4
|
0 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
2 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
Postgraduate year
Level 5
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
Postgraduate year
Level 6
|
2 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
0 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
3 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
No. endovascular cases assisted
0-5
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
2 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
2 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
5 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
No. endovascular cases assisted
5-10
|
2 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
4 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
No. endovascular cases assisted
10-50
|
6 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
5 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
12 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
No. endovascular cases assisted
50-100
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
5 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
7 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
|
No. endovascular cases assisted
100-200
|
1 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
0 Participants
n=7 Participants • Row population differs from the overall as participants are spread accross study arms
|
0 Participants
n=5 Participants • Row population differs from the overall as participants are spread accross study arms
|
1 Participants
n=4 Participants • Row population differs from the overall as participants are spread accross study arms
|
PRIMARY outcome
Timeframe: 6 weeks after interventionThe 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.
Outcome measures
| Measure |
PROSPECT
n=9 Participants
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
|
E-LEARNING
n=10 Participants
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.
|
CONTROL
n=10 Participants
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
|
|---|---|---|---|
|
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
|
28.42 score on a scale
Standard Deviation 2.15
|
23.09 score on a scale
Standard Deviation 2.18
|
|
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
|
53.63 score on a scale
Standard Deviation 3.34
|
38.72 score on a scale
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
PROSPECT
n=9 Participants
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
|
E-LEARNING
n=10 Participants
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.
|
CONTROL
n=10 Participants
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
|
|---|---|---|---|
|
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
|
14.88 score on a test or scale
Standard Deviation 1.13
|
14 score on a test or scale
Standard Deviation 2.49
|
|
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
|
17.88 score on a test or scale
Standard Deviation 0.99
|
15.2 score on a test or scale
Standard Deviation 2.7
|
|
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
|
17.71 score on a test or scale
Standard Deviation 0.75
|
NA score on a test or scale
Standard Deviation NA
data not collected from this arm/group at 3m
|
|
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
|
16.25 score on a test or scale
Standard Deviation 4.1
|
18 score on a test or scale
Standard Deviation 7.75
|
|
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
|
32.75 score on a test or scale
Standard Deviation 13.51
|
21.2 score on a test or scale
Standard Deviation 7.48
|
|
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
|
24.14 score on a test or scale
Standard Deviation 6.65
|
NA score on a test or scale
Standard Deviation NA
data not collected from this arm/group at 3m
|
|
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
|
35.63 score on a test or scale
Standard Deviation 11.38
|
37.6 score on a test or scale
Standard Deviation 13.98
|
|
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
|
59.25 score on a test or scale
Standard Deviation 16.73
|
42.8 score on a test or scale
Standard Deviation 15.39
|
|
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
|
51.71 score on a test or scale
Standard Deviation 16.31
|
NA score on a test or scale
Standard Deviation NA
data not collected from this arm/group at 3m
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After RCTAfter the RCT, a registry was started with all participants that started PROSPECT. Outcome: do PROSPECT participants pass the curriculum, do they become proficient?
Outcome measures
Outcome data not reported
Adverse Events
PROSPECT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
E-LEARNING
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place