Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?

This study has been completed.
Sponsor:
Collaborators:
Tulane University
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Dimitrios Stefanidis, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01052168
First received: January 18, 2010
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

Emphasizing the growing popularity of motion metrics are the majority of available virtual reality simulators and some newer hybrid models that offer motion tracking for performance assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic instruments in a box-trainer while automatically recording task duration and movement efficiency (pathlength and smoothness) that are immediately offered as feedback to trainees.

Despite the increasing availability of simulators that track motion, our knowledge of the impact those metrics have on trainee learning is severely limited. We do not know if it is more important to use speed, accuracy, motion efficiency or a combination thereof for performance assessment and how these metrics impact skill transfer to the OR.

Based on sound educational principles we have developed a proficiency-based laparoscopic suturing simulator curriculum. This curriculum focuses on deliberate and distributed practice, provides trainees with augmented feedback and sets expert-derived performance goals based on time and errors. We have previously demonstrated that this curriculum leads to improved operative performance of trainees compared to controls.

To measure operative performance and determine transferability, we will use a live porcine Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model is preferable for this purpose as it offers objective metrics (targets are established, distances measured, knots are disrupted for slippage scoring), complete standardization, and allows multiple individuals to be tested on the same day.

We hypothesize that proficiency-based simulator training in laparoscopic suturing to expert-derived levels of speed and motion will result in better operative performance compared to participants training to levels of speed or motion alone. The study is powered to detect an at least 10% performance difference between the groups.

Specific Aims

  1. Compare whether any performance differences between the groups persist long-term
  2. Assess whether the groups demonstrate differences in safety in the operating room by comparing the inadvertent injuries in the animal OR between the groups
  3. Identify the training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics
  4. Identify any baseline participant characteristics that may predict individual metric-specific performance

Condition Intervention
Performance Assessment
Motion Metrics
Other: skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Laparoscopic suturing performance in the animal operating room [ Time Frame: end of training and retention test after 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • inadvertent injuries in the animal OR [ Time Frame: end of training test and 3 month retention test ] [ Designated as safety issue: Yes ]
  • training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics [ Time Frame: end of study (within one year) ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Speed Group
The Speed Group, (n=20) will train in laparoscopic suturing on the validated FLS suturing model until the expert level of speed (i.e. task duration < 70 seconds) has been achieved on two consecutive attempts.
Other: skills training
participants will train using different performance goals (based on different metrics)
Experimental: Motion Group
The Motion Group, (n=20) will train in laparoscopic suturing until expert levels of motion (pathlength 6700 and smoothness 560) have been achieved.
Other: skills training
participants will train using different performance goals (based on different metrics)
Experimental: Speed and Motion Group
The Speed and Motion Group (n=20) will train in laparoscopic suturing until expert levels of speed AND motion have been achieved.
Other: skills training
participants will train using different performance goals (based on different metrics)

Detailed Description:

OBJECTIVE:: We hypothesized that training to expert-derived levels of speed and motion will lead to improved learning and will translate to better operating room (OR) performance of novices than training to goals of speed or motion alone. BACKGROUND:: Motion tracking has been suggested to be a more sensitive performance metric than time and errors for the assessment of surgical performance. METHODS:: An institutional review board-approved, single blinded, randomized controlled trial was conducted at our level-I American College of Surgeons accredited Education Institute. Forty-two novices trained to proficiency in laparoscopic suturing after being randomized into 3 groups: The speed group (n = 14) had to achieve expert levels of speed, the motion group (n = 15) expert levels of motion (path length and smoothness), and the speed and motion group (n = 13) both levels. To achieve proficiency, all groups also had to demonstrate error-free performance. The FLS suture module (task 5) was used for training inside the ProMIS simulator that tracks instrument motion. All groups participated in transfer and retention tests in the OR. OR performance was assessed by a blinded expert rater using Global Operative Assessment of Laparoscopic Skills, speed, accuracy, and inadvertent injuries.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • novices with no previous laparoscopic or simulation experience
  • voluntary participation

Exclusion Criteria:

  • expert in or familiarity with laparoscopy or simulation
  • physical condition that prevents the performance of laparoscopic suturing
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01052168

Locations
United States, North Carolina
Carolinas Simulation Center
Charlotte, North Carolina, United States, 28205
Sponsors and Collaborators
Carolinas Healthcare System
Tulane University
Ethicon Endo-Surgery
Investigators
Principal Investigator: Dimitrios Stefanidis, MD, PhD Carolinas Simulation Center
  More Information

Publications:
Ericsson KA, Krampe RT, Tesch-Romer C. The role of deliberate practice in the acquisition of expert performance. Psychol Rev 1993; 100:363-406.
Ericsson KA, Charness N. Expert performance: its structure and acquisition. Am Psychol 1994; 49:725-47.
Noether, Gottfried E., "Sample Size Determination for Some Common Nonparametric Tests". Journal of the American Statistical Association 1987; Vol. 82, No. 398, p. 647.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitrios Stefanidis, Dimitrios Stefanidis, MD, PhD, Carolinas Simulation Center., Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01052168     History of Changes
Other Study ID Numbers: 11-06-20E
Study First Received: January 18, 2010
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
simulation
simulators
motion metrics
performance metrics
skills training
proficiency
laparoscopic

Additional relevant MeSH terms:
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014