Evaluation of Control Chart Impact on Surgical Outcomes

Digestive Surgery Clinical Trial

— SHEWHART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569450
• Other study ID #: 69HCL14_0282
• Status: Completed
• Start date: October 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157594
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive Surgery

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Pôle IMER	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any major adverse event during hospitalization	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	Occurrence of any death during hospitalization within 30 days of surgery		within 30 days following surgical procedure
Secondary	Occurrence of any complication during hospitalization within 30 days of surgery		at the end of hospitalization
Secondary	Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery		within 30 days following surgical procedure
Secondary	Occurrence of reoperation during hospitalization within 30 days of surgery		within 30 days following surgical procedure
Secondary	Number of hospital bed-days consumed		within 30 days following surgical procedure
Secondary	Hospitalization costs from a health insurance perspective		within 30 days following surgical procedure