Evaluation of Control Chart Impact on Surgical Outcomes (SHEWHART)

Civil Hospices of Lyon

Status: Completed

Conditions: Digestive Surgery

Treatments: Behavioral: Surgical outcomes monitoring using Shewhart control chart

Study type: Observational

Funder types: Other

Identifiers

NCT02569450

69HCL14_0282

Details and patient eligibility

About

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.

Enrollment: 157,594 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

157,594 participants in 2 patient groups

Intervention arm

Description:

Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring

Treatment:

Behavioral: Surgical outcomes monitoring using Shewhart control chart

Hospitals in control arm

Description:

Hospitals randomly assigned to the control arm without surgical outcome monitoring