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Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees (PROSPECT)

23. februar 2021 oppdatert av: University Ghent

The Study of Transferability and Cost-effectiveness of a Proficiency-based Stepwise Endovascular Curricular Training Program (PROSPECT) in Surgical Trainees

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

39

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Ghent, Belgia, 9000
        • Ghent University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: additional curriculum (E-learning + simulation)
Ingen inngripen: CONTROL
The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.
Eksperimentell: 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.
Annen: additional E-learning

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Technical and Global Performance of the Surgical Trainee in Real Life Procedures
Tidsramme: 6 weeks after intervention

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PROSPECT Proficiency
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

University Ghent

Etterforskere

  • Hovedetterforsker: Isabelle Van Herzeele, MD, PhD, University Ghent

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2014

Primær fullføring (Faktiske)

1. februar 2016

Studiet fullført (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først innsendt

15. oktober 2013

Først innsendt som oppfylte QC-kriteriene

15. oktober 2013

Først lagt ut (Anslag)

18. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. februar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2013/783

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