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Clinical Trials/NCT04532658
NCT04532658CompletedNot Applicable

Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program

Hospices Civils de Lyon1 site in 1 country20,791 target enrollmentStarted: February 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20,791
Locations
1
Primary Endpoint
Operative time

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention arm

Experimental

Surgeons randomly assigned to the intervention arm

Intervention: Coaching program (Behavioral)

Control arm

No Intervention

Surgeons randomly assigned to the control arm

Outcomes

Primary Outcomes

Operative time

Time Frame: From skin incision to wound closure

Occurrence of unplanned reoperation

Time Frame: Within 30 days after the operation

Occurrence of death

Time Frame: During surgery or 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

Occurrence of major adverse event

Time Frame: During surgery or within 30 days after the operation

Surgeon well-being

Time Frame: Throughout the study, Through study completion, an average of 1 year

Length of stay

Time Frame: From hospital admission to discharge, within 30 days after operation

Hospitalization costs

Time Frame: Within 30 days after the operation

Occurrence of unplanned stay in critical/intensive care unit

Time Frame: Within 30 days after the operation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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