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Evaluation of Coaching Impact on Surgical Outcomes (TopSurgeons)

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ClinicalTrials.gov Identifier: NCT04532658
Recruitment Status : Not yet recruiting
First Posted : August 31, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE August 31, 2020
Last Update Posted Date September 9, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Occurrence of major adverse event [ Time Frame: During surgery or within 30 days after the operation ]
  • Occurrence of death [ Time Frame: During surgery or within 30 days after the operation ]
  • : Occurrence of unplanned stay in critical/intensive care unit [ Time Frame: Within 30 days after the operation ]
  • Occurrence of unplanned reoperation [ Time Frame: Within 30 days after the operation ]
  • Occurrence of intraoperative and postoperative complications [ Time Frame: During surgery or within 30 days after the operation ]
  • : Occurrence of avoidable hospital readmission for complication [ Time Frame: Within 30 days after the operation ]
  • Operative time [ Time Frame: From skin incision to wound closure ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • Occurrence of death [ Time Frame: During surgery or within 30 days after the operation ]
  • : Occurrence of unplanned stay in critical/intensive care unit [ Time Frame: Within 30 days after the operation ]
  • Occurrence of unplanned reoperation [ Time Frame: Within 30 days after the operation ]
  • Occurrence of intraoperative and postoperative complications [ Time Frame: During surgery or within 30 days after the operation ]
  • : Occurrence of avoidable hospital readmission for complication [ Time Frame: Within 30 days after the operation ]
  • Operative time [ Time Frame: From skin incision to wound closure ]
  • Occurrence of major adverse event [ Time Frame: During surgery or within 30 days after the operation ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Coaching Impact on Surgical Outcomes
Official Title  ICMJE Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program
Brief Summary This two arms parallel cluster-randomized trial will evaluate the impact of a customized coaching program for surgeons on the occurrence of patient major adverse events. Trends in surgical outcomes before and after the intervention will be compared between surgeons randomly assigned to the coaching program against non-exposed surgeons.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Surgery
Intervention  ICMJE Behavioral: Coaching program
  • Charting system for outcomes feedback
  • Profiling of individual surgeon
  • Modules of improvement
Study Arms  ICMJE
  • Experimental: Intervention arm
    Surgeons randomly assigned to the intervention arm
    Intervention: Behavioral: Coaching program
  • No Intervention: Control arm
    Surgeons randomly assigned to the control arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2020)
16000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All adults needing a surgery who are operated by one of the participating surgeons

Exclusion Criteria:

  • Age < 18 years old
  • Absence of surgical procedure
  • Palliative care
  • Organ transplantation
  • Refusal for personal data sharing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antoine Duclos 624302202 ext +33 antoineduclos@yahoo.fr
Contact: Jean-christophe Lifante 4 78 56 90 95 ext +33 jean-christophe.lifante@chu-lyon.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04532658
Other Study ID Numbers  ICMJE TOPSURGEONS_2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP