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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring |
| |
| Hospitals in control arm | Hospitals randomly assigned to the control arm without surgical outcome monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical outcomes monitoring using Shewhart control chart | Behavioral |
|
| 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 |
| 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 |
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Inclusion Criteria:
- All adults needing a digestive surgery who are hospitalized in one of the 40 departments
Exclusion Criteria:
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All patients operated in participating French public and private hospitals (cluster)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon, Pôle IMER | Lyon | 69003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37553238 | Derived | Skinner S, Pascal L, Polazzi S, Chollet F, Lifante JC, Duclos A; SHEWHART Trial Group. Economic analysis of surgical outcome monitoring using control charts: the SHEWHART cluster randomised trial. BMJ Qual Saf. 2024 Apr 24;33(5):284-292. doi: 10.1136/bmjqs-2022-015390. | |
| 33148601 | Derived | Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group. Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840. |
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| 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 |