PROSPECT: PROficiency Based StePwise Endovascular Curricular Training: Multicentric Registry

Sponsor

University Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT05620186

Collaborator

(none)

120

Enrollment

Locations

Arms

119.5

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if:

Results from a previous randomised controlled trail can be reproduced in real life.
Evaluate skills retention after program completion.
Assess real life implementation of the training program.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases	Other: PROSPECT	N/A

Detailed Description

A validated PROSPECT (PROficiency-based StePwise Endovascular Curricular Training) training has been integrated into the training of surgical residents to teach basic cognitive, technical and non-technical endovascular skills. The program uses virtual reality simulation and E-learning. During the four modules of the program, formative feedback is given after each training session. Only after achieving a predetermined benchmark score, trainees can progress to the next module.

Surgical trainees completing PROSPECT showed superior real live endovascular performance compared to the traditionally trained in a single centre randomised controlled trial (RCT). The curriculum was integrated locally, but also introduced in other centers: national and international. Local tutors teach the curriculum to trainees after standardized training on the modalities of PROSPECT by the researchers of the Ghent.

A registry is maintained and coordinated by the Ghent research group in which all educational data regarding this training is collected and processed anonymously.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Registry, no comparisonRegistry, no comparison

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Registry Endovascular Training Curriculum PROSPECT for Surgical Trainees (PROficiency-based StePwise Endovascular Curricular Training Program)

Actual Study Start Date :

Oct 17, 2017

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Original PROSPECT Original, distributed PROSPECT where trainees learn at their own pace in between, before/after clinical activities	Other: PROSPECT PROficiency Based StePwise Endovascular Curricular Training
Other: Massed PROSPECT Massed, bootcamp-style training form of PROSPECT where trainees are exempt from clinical duties	Other: PROSPECT PROficiency Based StePwise Endovascular Curricular Training

Arm

Intervention/Treatment

Other: Original PROSPECT

Original, distributed PROSPECT where trainees learn at their own pace in between, before/after clinical activities

Other: PROSPECT

PROficiency Based StePwise Endovascular Curricular Training

Other: Massed PROSPECT

Massed, bootcamp-style training form of PROSPECT where trainees are exempt from clinical duties

Other: PROSPECT

PROficiency Based StePwise Endovascular Curricular Training

Outcome Measures

Primary Outcome Measures

Cognitive skills [comparison before program start and after completion. This means through study completion.]
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Technical skills [comparison before program start and after completion. This means through study completion.]
Rating scale assessment and simulator metrics

Secondary Outcome Measures

Cognitive skills retention [3, 6 and 12 months after program completion]
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Technical skills retention [3, 6 and 12 months after program completion]
Rating scale assessment and simulator metrics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital Ghent	Ghent	Belgium	9000
2	KU Leuven	Leuven	Belgium	3000
3	CAMES	Copenhagen	Denmark	2100

Sponsors and Collaborators

University Ghent

Investigators

Principal Investigator: Isabelle Van Herzeele, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

Soenens G, Lawaetz J, Bamelis AS, Nayahangan LJ, Konge L, Eiberg J, Van Herzeele I. International Implementation of a PROficiency based StePwise Endovascular Curricular Training (PROSPECT) in Daily Practice. Eur J Vasc Endovasc Surg. 2021 Dec;62(6):992-998. doi: 10.1016/j.ejvs.2021.09.029. Epub 2021 Nov 12.

Responsible Party:

University Ghent

ClinicalTrials.gov Identifier:

NCT05620186

Other Study ID Numbers:

B670201630090

First Posted:

Nov 17, 2022

Last Update Posted:

Nov 17, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University Ghent

simulation based education

endovascular procedures

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Nov 17, 2022