Objective Assessment of Technical Skills in Cardiothoracic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01433029
First received: September 8, 2011
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The goal of this research study is to develop a method of rating videos of CAB procedures that will produce a reliable assessment of a cardiothoracic surgical trainee's technical proficiency. In addition, researchers also want to learn if using a video manual to train raters can help improve rater reliability.


Condition Intervention
Other Surgical Procedures
Other: Surgical Video Assessments
Other: Video Recording of CAB

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Assessment of Technical Skills in Cardiothoracic Surgery

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of Video Recordings of Cardiothoracic Surgery (CTS) Procedures [ Time Frame: 1 month for rating ] [ Designated as safety issue: No ]
    Assessing 5 recorded procedures with qualified raters using two rating scales; a checklist developed using a consensus building project and a global rating scale (GRS) adapted from an established surgical assessment tool. The GRS uses a 5 point scale and behavioral anchors are provided for 1, 3, and 5 (a score of 1 equals a novice, 3 equals a competent surgeon, and 5 equals an expert). Raters have 1 month to view videos.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Conventional Rater (CR)
CR Group receives conventional training from PI about how to rate coronary artery bypass (CAB) videos.
Other: Surgical Video Assessments
Rate performance of the surgeon/trainee in each CAB video performance (5 recorded procedures) using two rating scales, a checklist and the Global Rating Scale. Up to 38 different recorded procedures rated while on the study, each procedure lasting about 15 minutes.
Video Rater (VR)
VR Group receives conventional training from PI about how to rate CAB videos, along with a video rater training manual.
Other: Surgical Video Assessments
Rate performance of the surgeon/trainee in each CAB video performance (5 recorded procedures) using two rating scales, a checklist and the Global Rating Scale. Up to 38 different recorded procedures rated while on the study, each procedure lasting about 15 minutes.
CAB Recording
CAB recording of performance cardiothoracic surgeon or surgical trainee in 1st, 2nd, or 3rd year of training.
Other: Video Recording of CAB
Each video begins when dissection of a coronary artery has begun and ends when all manipulation of anastomosis is complete. At least 6 separate anastomoses will be recorded, or at least 2-3 procedures. A ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that is worn on the head) records the performance of the coronary artery bypass (CAB) procedures.

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  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training. Experienced faculty are cardiothoracic surgeons who regularly perform coronary artery bypass (CAB) procedures and have at least 10 years of post-training experience.

Criteria

Inclusion Criteria:

  1. The trainee must be a cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training and must be currently enrolled at any of the following institutions: U.T. Health Science Center in Houston, The Texas Heart Institute/Baylor College of Medicine, U.T. San Antonio, U. T. Southwestern, U.T. M.D. Anderson Cancer Center, and The Methodist Hospital.
  2. The trainee must provide an informed consent to participate.
  3. The experience faculty must be a cardiothoracic surgeon who regularly performs CAB procedures and has at least 10 years of post-training experience.
  4. The experienced faculty is currently operating at the same institutions listed in inclusion criterion 1.
  5. The experienced faculty must provide written informed consent to participate.
  6. The faculty rater must be a cardiothoracic surgeon who regularly performs CAB procedures, is practicing in an Adult Cardiothoracic Graduate Medical Evaluation (ACGME) approved CTS training program, and has practiced at least 5 years after certification by the American Board of Thoracic Surgery (ABTS). There is no restriction on geographic location.
  7. The expert CAB surgeon for Consensus Building must be a cardiothoracic surgeon who regularly performs CAB procedures, is practicing in an ACGME approved CTS training program, and has practiced at least 10 years after certification by the ABTS. There is no restriction on geographic location.

Exclusion Criteria:

N/A

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433029

Contacts
Contact: Ara Vaporciyan, MD, BS 713-563-9152

Locations
United States, Texas
The University of Texas Southwestern Medical Center in Dallas Recruiting
Dallas, Texas, United States, 75390
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Heart Institute at St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
The University of Texas Medical School at Houston Recruiting
Houston, Texas, United States, 77030
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ara Vaporciyan, MD,BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01433029     History of Changes
Other Study ID Numbers: 2010-0595
Study First Received: September 8, 2011
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Surgical Procedure
Assessment
Cardiothoracic Surgery
Coronary artery bypass
CAB
Video recordings
Global rating scale
GRS
Cardiothoracic surgeon
Surgical trainees

ClinicalTrials.gov processed this record on August 20, 2014