- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02986217
The Effect of Structured Feedback on Live Surgical Performance (CSATS)
The Effect of Structured Feedback on Live Surgical Performance: A Single-Blind Randomized Control Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The American Association of Gynecologic Laparoscopists (AAGL) and Accreditation Council of Graduate Medical Education (ACGME) have endeavored to implement structure and standardization for the fellowship in minimally invasive gynecologic surgical programs (FMIGS) and obstetric and gynecology residency programs respectively. Educational objectives are explicitly delineated. Though the fellowship and residency educational objectives are well rounded, and include the development of skills to become leaders and educators in the field of minimally invasive gynecologic surgery (MIGS) and general obstetrics and gynecology, one of the main objective of the fellowship and residency training is the attainment of surgical skill. This is ensured by a requirement for a breadth of surgical exposure including vaginal surgery, hysteroscopy, traditional laparoscopy, management of surgical complications, minimally invasive hysterectomy, urogynecologic procedures, gastrointestinal surgery, urinary tract surgery, reproductive surgery, and the surgical management of common gynecologic conditions such as endometriosis. Minimum case requirements have been implemented to provide guidance for FMIGS and residency programs. In addition, trainees are required to log surgical cases and this information is utilized for FMIGS and residency program site inspections as well as for feedback of surgical competency. Despite standardization efforts by the AAGL and ACGME, the FMIGS and obstetric and gynecology residency curriculums are still in evolution. There is likely still great variation in surgical exposure between programs. In addition, though regular feedback is a requirement of training programs, the process is likely unstructured and subjective; based on case logs, self-assessments, and feedback by faculty surgeons. There is thus a critical need to develop a standardized, objective, timely, and actionable feedback methodology to facilitate program oversight and ensure FMIGS fellows and obstetrics and gynecology residents are achieving surgical competency throughout their training. In the absence of such structured feedback models, it will remain difficult to optimize FMIGS fellowship and obstetrics and gynecology resident training, and provide objective measurements of the impact of such training on surgical performance and patient outcomes. .
The long-term goal of this study is to assist in developing methods for surgical assessment that facilitate program oversight, allow fellows, residents, and program directors to identify specific skill sets in need of improvement, monitor progress in skill acquisition, and clearly and objectively document achievement of milestones throughout training. The study's overall objective is to determine how consistent structured feedback using crowd sourcing impacts time to complete a task as well as surgical performance as measured by GOALS and GEARS scores. The central hypothesis is that fellows and residents who receive consistent structured feedback over a sustained period of time will have shorter task times, overall improved performance, and greater satisfaction than fellows and residents receiving traditional feedback. The rationale for this work is that it will provide focus and supportive data for large-scale studies of surgical skill acquisition and development.
This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with GOALS and GEARS through a randomized controlled trial. The study hypothesizes regular structured assessment will lead to a greater measurable improvement in performance, as defined by change and GOALS and GEARS scores, than will traditional feedback methods as well as time to complete a specific procedure.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- current position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
- participants must be between 18 and 60 years of age
Exclusion Criteria:
- persons not in a position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- persons not a FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
- participants younger than 18 and older than 60 years of age
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control Group
Participants randomized to the Control Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy.
Subjects in the control group will receive traditional feedback methods as determined by each participant's training program.
Subjects in the control group will repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles.
At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
|
|
Eksperimentel: Experimental Group
Participants randomized to the Experimental Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy.
Subjects in the experimental group will then receive feedback within 5 business days of video submission and repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles.
At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
difference in mean time needed to perform cuff closure during hysterectomy
Tidsramme: 6 weeks post study enrollment
|
The difference in mean time (measured in minutes) needed to perform vaginal cuff closure during hysterectomy between subjects in the control versus experimental groups.
|
6 weeks post study enrollment
|
difference in mean surgical performance score
Tidsramme: 6 weeks post study enrollment
|
The difference in mean surgical performance score of a vaginal cuff closure at the time of hysterectomy between participants in the control versus experimental groups.
|
6 weeks post study enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
difference in trainee satisfaction with feedback method
Tidsramme: 6 weeks post study enrollment
|
the difference in mean satisfaction score between participants in the control versus experimental groups
|
6 weeks post study enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 101614
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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 .
Kliniske forsøg med Kirurgisk Uddannelse
-
Eastern Mediterranean UniversityRekrutteringSygeplejestuderende | Flipped Education ModelCypern
-
The Hospital for Sick ChildrenAfsluttetEvaluering af HomeCare RN Respiratory EducationCanada
-
Akdeniz UniversityAfsluttetSygeplejerskers opfattelse af intentionalitet | Intentionalitetens Facilitatorer | hindringerne for intentionalitet | Effektiviteten af Mindful Caring Education ProgramKalkun
-
National Taiwan University HospitalAfsluttetEffektiviteten af Application Education InterventionTaiwan
-
Kahramanmaras Sutcu Imam UniversityAfsluttetFedme, sygelig | Perioperativ komplikation | BMD | Laparaskopisk ærmegatrektomi | Fedmekirurgi Dødelighedsscore | Clavien Dindo Surgical Complication Scale
-
Seoul National University HospitalAfsluttetNakke smerter | Myelopati Cervikal | Ossifikation af posterior langsgående ledbånd | Cervikal spondylose med myelopati | Kyphosis Post SurgicalKorea, Republikken