- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00934310
Introduction of the Surgical Safety Checklist
Patient Safety: Introduction of the Surgical Safety Checklist and Patient Outcome Assessment in an Academic Ambulatory Hospital
In January of 2007, the World Health Organization's (WHO) World Alliance for Patient Safety initiated a project called "Safe Surgery Saves Lives" to identify minimum standards of surgical care that can be universally applied across countries and settings. Through a two year process involving international input from surgeons, anesthesiologists, nurses, infectious disease specialists, epidemiologists and others, the WHO created a surgical safety checklist that encompasses a simple set of surgical safety standards that can be used in any surgical setting. Each safety step on the checklist is simple, widely applicable, and measurable. The Surgical Safety Checklist was piloted in 8 hospitals around the world and results demonstrated a significant decrease in death rate and postoperative complications.
This study proposes to introduce an adaptation of the Surgical Safety Checklist for an ambulatory care surgical program and to assess the efficacy of its adaptation and implementation on staff safety attitudes and patient outcomes. Specific ambulatory-based items will be included in the checklist and patient outcomes will be assessed using the Institute for Health Improvement's Perioperative Surgical Outcomes Tool which will also be adapted for use for the ambulatory setting as well as routine follow up phone calls with patients on the 1st postoperative day.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1B2
- Women's College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ambulatory surgical patient
Exclusion Criteria:
- in-patient or any patient who is planning to be admitted to hospital postoperatively
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Ambulatory Surgical Patients 1
The nature of the operating room "time out" for ambulatory surgical patients will be examined before implementation of the World Health Organization's Surgical Safety Checklist.
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Ambulatory Surgical Patients 2
The nature of the operating room "time out" for ambulatory surgical patients will be examined after implementation of the World Health Organization's Surgical Safety Checklist.Ambulatory surgical patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The primary outcomes of this study are to determine if there are significant differences in (a) staff safety attitudes and (b) incidence of postoperative complications before and after implementation of the Surgical Safety Checklist
Time Frame: Before and after implementation of checklist
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Before and after implementation of checklist
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The primary outcomes of this study are to determine if there are significant differences in (a) staff safety attitudes and (b) incidence of postoperative complications before and after implementation of the Surgical Safety Checklist
Time Frame: Before and after implementation of the safety checklist
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Before and after implementation of the safety checklist
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Collaborators and Investigators
Investigators
- Principal Investigator: Pamela J Morgan, MD, Women's College Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-0017-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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