Evaluation of Control Chart Impact on Surgical Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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Digestive Surgery

Intervention / Treatment
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* Behavioral: Surgical outcomes monitoring using Shewhart control chart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention arm<br>Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring | Behavioral: Surgical outcomes monitoring using Shewhart control chart<br>* 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<br>|
| Hospitals in control arm<br>Hospitals randomly assigned to the control arm without surgical outcome monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Performance, Outcome, Control chart