Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Coaching Impact on Surgical Outcomes (TopSurgeons)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Surgery Behavioral: Coaching program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Arm Intervention/treatment
Experimental: Intervention arm
Surgeons randomly assigned to the intervention arm
Behavioral: Coaching program
  • Charting system for outcomes feedback
  • Profiling of individual surgeon
  • Modules of improvement

No Intervention: Control arm
Surgeons randomly assigned to the control arm



Primary Outcome Measures :
  1. Occurrence of major adverse event [ Time Frame: During surgery or within 30 days after the operation ]
  2. Occurrence of death [ Time Frame: During surgery or within 30 days after the operation ]
  3. : Occurrence of unplanned stay in critical/intensive care unit [ Time Frame: Within 30 days after the operation ]
  4. Occurrence of unplanned reoperation [ Time Frame: Within 30 days after the operation ]
  5. Occurrence of intraoperative and postoperative complications [ Time Frame: During surgery or within 30 days after the operation ]
  6. : Occurrence of avoidable hospital readmission for complication [ Time Frame: Within 30 days after the operation ]
  7. Operative time [ Time Frame: From skin incision to wound closure ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532658


Contacts
Layout table for location contacts
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

Sponsors and Collaborators
Hospices Civils de Lyon
Additional Information:
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04532658    
Other Study ID Numbers: TOPSURGEONS_2020
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No