- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02000180
Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
Do Progressive Levels of Simulation Fidelity Enhance Colonoscopic Skill Acquisition and Transfer in Novice Endoscopic Trainees?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive Knowledge of Endoscopy
Délai: 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.
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Samir C Grover, MD/MEd, Unity Health Toronto
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-060
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cancer colorectal
-
University of California, San FranciscoComplétéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
-
City of Hope Medical CenterRecrutementTumeurs colorectales | Cancer colorectal | Troubles colorectaux | Adénocarcinome colorectal | Cancer colorectal stade II | Cancer colorectal stade III | Cancer colorectal stade IV | Polype colorectal | Tumeurs colorectales malignes | Polype adénomateux colorectal | Cancer colorectal stade I | Adénome colorectal... et d'autres conditionsÉtats-Unis, Italie, Chine, Espagne, Japon
-
M.D. Anderson Cancer CenterRecrutementAdénocarcinome colorectal | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de... et d'autres conditionsÉtats-Unis
-
University of Southern CaliforniaNational Cancer Institute (NCI)Actif, ne recrute pasCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
-
Docbot, Inc.RecrutementAdénome colorectal | Adénocarcinome colorectal | Polype colorectal | ASS colorectalÉtats-Unis
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)RésiliéCancer rectal | Cancer du colon | Survivant du cancer | Adénocarcinome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal... et d'autres conditionsÉtats-Unis
-
Bundang CHA HospitalPas encore de recrutementAdénome colorectal | Lésion précancéreuse du cancer colorectalCorée du Sud
-
Sidney Kimmel Comprehensive Cancer Center at Thomas...United States Department of DefenseActif, ne recrute pasAdénome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade 0 AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal de stade II... et d'autres conditionsÉtats-Unis
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...ComplétéCancer colorectal métastatique | Adénocarcinome colorectal | Cancer colorectal de stade IV | Cancer colorectal de stade IVA | Cancer colorectal de stade IVB | Carcinome colorectal réfractaire | Carcinome colorectal stable microsatellite métastatique | Cancer colorectal de stade IVCÉtats-Unis
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCRetiréAdénocarcinome colorectal métastatique | Adénocarcinome colorectal réfractaire | Microsatellite Stable | Cancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade... et d'autres conditionsÉtats-Unis
Essais cliniques sur Progressive Group
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalComplété
-
Ankara Etlik City HospitalRecrutementVentilation mécanique | Lumbar Disc Herniation SurgeryTurquie (Türkiye)
-
Aarhus University HospitalUniversity of AarhusComplétéCancer du sein féminin | Peur de la récidive du cancerDanemark
-
University Hospital, BrestPas encore de recrutement
-
Children's National Research InstituteComplétéFormation sur la sécurité des sièges d'auto pour enfantsÉtats-Unis
-
Arizona Oncology ServicesInconnueCancer du sein localisé | Cancer localisé de la prostate | Patients recevant une radiothérapie externeÉtats-Unis
-
Gaziosmanpasa Research and Education HospitalRecrutement
-
VA Palo Alto Health Care SystemUS Department of Veterans AffairsRecrutement
-
Merve GökçeComplétéHypoxémie | Dépression respiratoire | Désaturation en oxygèneTurquie (Türkiye)
-
hearX GroupUniversity of PretoriaComplété