- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01965860
Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees (PROSPECT)
The Study of Transferability and Cost-effectiveness of a Proficiency-based Stepwise Endovascular Curricular Training Program (PROSPECT) in Surgical Trainees
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Ghent, Belgie, 9000
- Ghent University Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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:
-
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: PROSPECT
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.
|
|
|
Žádný zásah: CONTROL
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
|
|
|
Experimentální: E-LEARNING
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Technical and Global Performance of the Surgical Trainee in Real Life Procedures
Časové okno: 6 weeks after intervention
|
The consultant will assess the trainee during the intervention.
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module
Časové okno: Pre curriculum, 6 weeks and 3 months after completion of the curriculum (3 months only for intervention arms)
|
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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PROSPECT Proficiency
Časové okno: After RCT
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Isabelle Van Herzeele, MD, PhD, University Ghent
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2013/783
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na additional curriculum (E-learning + simulation)
-
Antoine FourréUniversiteit Antwerpen; University of Mons; University of Picardie Jules VerneDokončenoBolesti v kříži | Fyzikální terapie | Znalosti, postoje, praxe | LékařiBelgie
-
McMaster UniversityDokončenoDeprese | ÚzkostKanada
-
Mayo ClinicNational Center for Research Resources (NCRR)Dokončeno
-
University GhentNáborPrevence sebevraždBelgie
-
Centre Hospitalier Universitaire VaudoisNáborPoruchou autistického spektraŠvýcarsko
-
Universiteit AntwerpenDokončenoPřežití rakoviny | Chronická bolest dolní části zad (CLBP) | Fyzioterapie a rehabilitaceBelgie
-
Maastricht University Medical CenterDokončeno
-
Radboud University Medical CenterMaastricht University Medical Center; ZonMw: The Netherlands Organisation for... a další spolupracovníciDokončenoDyspepsie | Špatné tráveníHolandsko
-
Mario Negri Institute for Pharmacological ResearchAgenzia Italiana del FarmacoDokončeno
-
Universitätsklinikum Hamburg-EppendorfGerman Cancer Research CenterNábor