PROficiency Based StePwise Endovascular Curricular Training: Multicentric Registry (PROSPECT)

December 4, 2024 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive skills
Time Frame: 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)
comparison before program start and after completion. This means through study completion.
Technical skills
Time Frame: comparison before program start and after completion. This means through study completion.
Rating scale assessment and simulator metrics
comparison before program start and after completion. This means through study completion.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2017

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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