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

Primary Purpose

Vascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PROSPECT
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vascular Diseases focused on measuring simulation based education, endovascular procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital GhentRecruiting
  • KU LeuvenRecruiting
  • CAMESRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Original PROSPECT

Massed PROSPECT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cognitive skills
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Technical skills
Rating scale assessment and simulator metrics

Secondary Outcome Measures

Cognitive skills retention
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Technical skills retention
Rating scale assessment and simulator metrics

Full Information

First Posted
November 2, 2022
Last Updated
November 10, 2022
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05620186
Brief Title
PROficiency Based StePwise Endovascular Curricular Training: Multicentric Registry
Acronym
PROSPECT
Official Title
Registry Endovascular Training Curriculum PROSPECT for Surgical Trainees (PROficiency-based StePwise Endovascular Curricular Training Program)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
October 1, 2027 (Anticipated)
Study Completion Date
October 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
simulation based education, endovascular procedures

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Registry, no comparison
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Original PROSPECT
Arm Type
Other
Arm Description
Original, distributed PROSPECT where trainees learn at their own pace in between, before/after clinical activities
Arm Title
Massed PROSPECT
Arm Type
Other
Arm Description
Massed, bootcamp-style training form of PROSPECT where trainees are exempt from clinical duties
Intervention Type
Other
Intervention Name(s)
PROSPECT
Intervention Description
PROficiency Based StePwise Endovascular Curricular Training
Primary Outcome Measure Information:
Title
Cognitive skills
Description
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Time Frame
comparison before program start and after completion. This means through study completion.
Title
Technical skills
Description
Rating scale assessment and simulator metrics
Time Frame
comparison before program start and after completion. This means through study completion.
Secondary Outcome Measure Information:
Title
Cognitive skills retention
Description
Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)
Time Frame
3, 6 and 12 months after program completion
Title
Technical skills retention
Description
Rating scale assessment and simulator metrics
Time Frame
3, 6 and 12 months after program completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Van Herzeele, MD, PhD
Phone
09 332 51 08
Ext
+32
Email
isabelle.vanherzeele@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Van Herzeele, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Van Herzeele, MD, PhD
Phone
093325108
Ext
+32
Email
isabelle.vanherzeele@ugent.be
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge Fourneau, MD, PhD
Email
inge.fourneau@kuleuven.be
Facility Name
CAMES
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Eiberg, MD, Phd
Email
jonas.peter.eiberg@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34782232
Citation
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.
Results Reference
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PROficiency Based StePwise Endovascular Curricular Training: Multicentric Registry

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