NCT04532658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,791

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

August 20, 2020

Last Update Submit

July 8, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Occurrence of major adverse event

    During surgery or within 30 days after the operation

  • Occurrence of death

    During surgery or within 30 days after the operation

  • Occurrence of unplanned stay in critical/intensive care unit

    Within 30 days after the operation

  • Occurrence of unplanned reoperation

    Within 30 days after the operation

  • Occurrence of intraoperative and postoperative complications

    During surgery or within 30 days after the operation

  • : Occurrence of avoidable hospital readmission for complication

    Within 30 days after the operation

  • Operative time

    From skin incision to wound closure

  • Length of stay

    From hospital admission to discharge, within 30 days after operation

  • Hospitalization costs

    Within 30 days after the operation

  • Surgeon well-being

    Throughout the study, Through study completion, an average of 1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

Surgeons randomly assigned to the intervention arm

Behavioral: Coaching program

Control arm

NO INTERVENTION

Surgeons randomly assigned to the control arm

Interventions

* Charting system for outcomes feedback * Profiling of individual surgeon * Modules of improvement

Intervention arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years old
  • Absence of surgical procedure
  • Palliative care
  • Organ transplantation
  • Refusal for personal data sharing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 31, 2020

Study Start

February 1, 2019

Primary Completion

January 31, 2024

Study Completion

January 31, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations