Evaluation of Control Chart Impact on Surgical Outcomes

NCT02569450 | Completed

• 1 other identifier: 69HCL14_0282
• Study Type: observational
• Target: 157,594
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Digestive Surgery

Keywords

Surgery; Performance; Outcome; Control chart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Intervention arm

Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring

Behavioral: Surgical outcomes monitoring using Shewhart control chart

Hospitals in control arm

Hospitals randomly assigned to the control arm without surgical outcome monitoring

Interventions

Surgical outcomes monitoring using Shewhart control chart BEHAVIORAL

* 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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon, Pôle IMER

Lyon, 69003, France

Location

Related Publications (2)

• 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.

  PMID: 37553238 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.

  PMID: 33148601 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

FR (1)