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Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training

8. august 2017 opdateret af: Samir Grover, Unity Health Toronto

Do Progressive Levels of Simulation Fidelity Enhance Colonoscopic Skill Acquisition and Transfer in Novice Endoscopic Trainees?

It is hypothesized that a progressive simulated learning strategy will result in better global clinical performance (e.g., technical, communication) and transfer of endoscopic skill, as compared with a high-fidelity simulation strategy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • novice endoscopists from Adult Gastroenterology, Pediatric Gastroenterology, General Surgery training programs at University of Toronto

Exclusion Criteria:

  • Trainees who have performed greater than 25 colonoscopies will be excluded to ensure all participants are novices.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Progressive Group
The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.
Adfærdsmæssigt: Progressive Group
Ingen indgriben: High-Fidelity Group
The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
Tidsramme: 4-6 weeks post-intervention
The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants before and after the intervention at a time of one week. A change in these ratings before and after intervention is the primary outcome.
4-6 weeks post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Knowledge of Endoscopy
Tidsramme: Pre-training, immediate post-training
Assessed via a multiple-choice question test on the theory and practice of endoscopy. Scores range from 0-100 with higher scores representing a more knowledge of the theory and practice of endoscopy.
Pre-training, immediate post-training
Colonoscopy Specific-performance.
Tidsramme: Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)
The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants on virtual reality colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.
Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Tidsramme: Immediate post-training and 4-6 weeks after training (delayed post-training)

Technical skills, communication skills, and global performance assessed during an integrated scenario through the JAG DOPS tool, integrated scenario communication rating form (ISCRF), and integrated scenario global rating form (ISGRF) respectively.

The JAG DOPS tool, as previously described, will be used to assess participants on integrated scenario colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.

The ISCRF and ISGRF are tools which measure communication skills and global performance with a standardized nurse and standardized patient during a simulated colonoscopy. These tools can have scores from 0-100, with higher scores representing better performance.
Immediate post-training and 4-6 weeks after training (delayed post-training)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Unity Health Toronto

Samarbejdspartnere

The Hospital for Sick Children

Efterforskere

  • Ledende efterforsker: Samir C Grover, MD/MEd, Unity Health Toronto

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2013

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

17. november 2013

Først indsendt, der opfyldte QC-kriterier

26. november 2013

Først opslået (Skøn)

4. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13-060

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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