Introduction of the Surgical Safety Checklist

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Women's College Hospital
Ontario Ministry of Health and Long Term Care
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00934310
First received: July 6, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition
Surgical "Time Out"
Postoperative Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Patient Safety: Introduction of the Surgical Safety Checklist and Patient Outcome Assessment in an Academic Ambulatory Hospital

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: May 2009
Estimated Study Completion Date: October 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory surgical patients

Criteria

Inclusion Criteria:

  • ambulatory surgical patient

Exclusion Criteria:

  • in-patient or any patient who is planning to be admitted to hospital postoperatively
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934310

Contacts
Contact: Pamela j Morgan, MD 416.323.6400 ext 4087 pam.morgan@utoronto.ca
Contact: Michele F Haley, BA 416.323.6400 ext 4087 michele.haley@gmail.com

Locations
Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5G 1B2
Contact: Pamela J Morgan, MD    416.323.6400 ext 4087    pam.morgan@utoronto.ca   
Contact: Michele F Haley, BA    416.323.6400 ext 4087    michele.haley@gmail.com   
Principal Investigator: Pamela J Morgan, MD         
Sub-Investigator: Jean Kronberg, MD         
Sub-Investigator: John Semple, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Women's College Hospital
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Pamela J Morgan, MD Women's College Hospital
  More Information

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pamela Morgan MD, FRCPC, Women's College Hospital
ClinicalTrials.gov Identifier: NCT00934310     History of Changes
Other Study ID Numbers: 2009-0017-E
Study First Received: July 6, 2009
Last Updated: July 21, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Patient Safety
Team work
Communication
Ambulatory surgical patients

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014