Evaluation of Control Chart Impact on Surgical Outcomes (SHEWHART)

March 2, 2022 updated by: Hospices Civils de Lyon

The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial

This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

157594

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon, Pôle IMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients operated in participating French public and private hospitals (cluster)

Description

Inclusion Criteria:

- All adults needing a digestive surgery who are hospitalized in one of the 40 departments

Exclusion Criteria:

  • Age < 18 years old
  • Hospitalization <24 hours
  • Absence of surgical procedure
  • Ambulatory care
  • Palliative care
  • Organ transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention arm
Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring
Behavioral: Surgical outcomes monitoring using Shewhart control chart
  • Assistance by a local surgeon responsible for the implementation of intervention within his/her department
  • Quarterly team meeting to interpret variations in observed outcomes on the control charts
  • Restitution of surgical outcomes based on wall posters in operating room
  • Training sessions provided to local surgeon for appropriate control chart utilization
Hospitals in control arm
Hospitals randomly assigned to the control arm without surgical outcome monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of any major adverse event during hospitalization
Time Frame: within 30 days following surgical procedure
Major adverse events include postoperative death, complication, unplanned intensive care stay or reoperation within 30 days of surgery.
within 30 days following surgical procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of any death during hospitalization within 30 days of surgery
Time Frame: within 30 days following surgical procedure
within 30 days following surgical procedure
Occurrence of any complication during hospitalization within 30 days of surgery
Time Frame: at the end of hospitalization
at the end of hospitalization
Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery
Time Frame: within 30 days following surgical procedure
within 30 days following surgical procedure
Occurrence of reoperation during hospitalization within 30 days of surgery
Time Frame: within 30 days following surgical procedure
within 30 days following surgical procedure
Number of hospital bed-days consumed
Time Frame: within 30 days following surgical procedure
within 30 days following surgical procedure
Hospitalization costs from a health insurance perspective
Time Frame: within 30 days following surgical procedure
within 30 days following surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL14_0282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe