Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees

NCT01965860 | Completed Results

• 1 other identifier: 2013/783
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Other Outcomes (1)

• PROSPECT Proficiency

  After RCT

Study Arms (3)

PROSPECT

EXPERIMENTAL

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.

Other: additional curriculum (E-learning + simulation)

CONTROL

NO INTERVENTION

The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.

E-LEARNING

EXPERIMENTAL

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.

Other: additional E-learning

Interventions

additional curriculum (E-learning + simulation) OTHER

PROSPECT

additional E-learning OTHER

E-LEARNING

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical trainee
• Knowledge and technical skill level evaluated
• Demographics questionnaire and general MCQ test completed
• endovascular simulated exercises completed after familiarization with the simulator

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related 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.

  PMID: 26276301 BACKGROUND

• 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;54(3):387-396. doi: 10.1016/j.ejvs.2017.06.011. Epub 2017 Jul 19.

  PMID: 28734705 RESULT

• 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: 10.1016/j.ejvs.2018.07.011. Epub 2018 Aug 18.

  PMID: 30131277 RESULT

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Limitations and Caveats

* Single centre, results may not be applicable to other centres/countries. * Randomisation status was not blinded for participants, consultant can unintentionally know randomisation group. * Long-term skills retention was not assessed beyond 3 months post-training. * As the procedures were closely supervised, operative metrics cannot be used to assess the operative performance.

Results Point of Contact

• Title: Prof. Dr. Isabelle Van Herzeele
• Organization: Ghent University

isabelle.vanherzeele@ugent.be

93325108

Study Officials

• Isabelle Van Herzeele, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Initially 39 participants were enrolled, 7 excluded because they declined to participate. 32 people were randomized.

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 18, 2013
• Study Start: August 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-01

Locations

BE (1)