Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees

Vascular Disease Clinical Trial

— PROSPECT  

Official title:

The Study of Transferability and Cost-effectiveness of a Proficiency-based Stepwise Endovascular Curricular Training Program (PROSPECT) in Surgical Trainees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965860
• Other study ID #: 2013/783
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

Other:
• additional curriculum (E-learning + simulation)

• additional E-learning

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Maertens H, Aggarwal R, Desender L, Vermassen F, Van Herzeele I. Development of a PROficiency-Based StePwise Endovascular Curricular Training (PROSPECT) Program. J Surg Educ. 2016 Jan-Feb;73(1):51-60. doi: 10.1016/j.jsurg.2015.07.009. Epub 2015 Aug 11. — View Citation

Maertens H, Aggarwal R, Moreels N, Vermassen F, Van Herzeele I. A Proficiency Based Stepwise Endovascular Curricular Training (PROSPECT) Program Enhances Operative Performance in Real Life: A Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2017 Sep — View Citation

Maertens H, Vermassen F, Aggarwal R, Doyen B, Desender L, Van Herzeele I, Annemans L. Endovascular Training Using a Simulation Based Curriculum is Less Expensive than Training in the Hybrid Angiosuite. Eur J Vasc Endovasc Surg. 2018 Oct;56(4):583-590. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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?	After RCT
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.	6 weeks after intervention
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	Pre curriculum, 6 weeks and 3 months after completion of the curriculum (3 months only for intervention arms)