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Evaluation of Control Chart Impact on Surgical Outcomes (SHEWHART)

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ClinicalTrials.gov Identifier: NCT02569450
Recruitment Status : Unknown
Verified August 2017 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : October 6, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Digestive Surgery Behavioral: Surgical outcomes monitoring using Shewhart control chart

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Study Type : Observational
Estimated Enrollment : 48000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial
Actual Study Start Date : October 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Group/Cohort Intervention/treatment
Intervention arm
Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring
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

Hospitals in control arm
Hospitals randomly assigned to the control arm without surgical outcome monitoring



Primary Outcome Measures :
  1. Occurrence of any major adverse event during hospitalization [ Time Frame: within 30 days following surgical procedure ]
    Major adverse events include postoperative death, complication, unplanned intensive care stay or reoperation within 30 days of surgery.


Secondary Outcome Measures :
  1. Occurrence of any death during hospitalization within 30 days of surgery [ Time Frame: within 30 days following surgical procedure ]
  2. Occurrence of any complication during hospitalization within 30 days of surgery [ Time Frame: at the end of hospitalization ]
  3. Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery [ Time Frame: within 30 days following surgical procedure ]
  4. Occurrence of reoperation during hospitalization within 30 days of surgery [ Time Frame: within 30 days following surgical procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients operated in participating French public and private hospitals (cluster)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569450


Contacts
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Contact: Jean-Christophe LIFANTE, MD 0478569095 ext +33 jean-christophe.lifante@chu-lyon.fr
Contact: Antoine DUCLOS, MD 0472115166 ext +33 antoine.duclos@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon, Pôle IMER Recruiting
Lyon, France, 69003
Contact: Antoine DUCLOS, MD         
Contact: François CHOLLET, MD         
Principal Investigator: Jean-Christophe LIFANTE, MD         
Sub-Investigator: Antoine DUCLOS, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02569450    
Other Study ID Numbers: 69HCL14_0282
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Hospices Civils de Lyon:
Surgery
Performance
Outcome
Control chart