NCT00934310

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

July 6, 2009

Last Update Submit

October 3, 2017

Conditions

Keywords

Patient SafetyTeam workCommunicationAmbulatory surgical patients

Outcome Measures

Primary Outcomes (2)

  • 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

    Before and after implementation of checklist

  • 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

    Before and after implementation of the safety checklist

Study Arms (2)

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 Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory surgical patients

You may qualify if:

  • ambulatory surgical patient

You may not qualify if:

  • in-patient or any patient who is planning to be admitted to hospital postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5G 1B2, Canada

Location

Related Publications (1)

  • Morgan PJ, Cunningham L, Mitra S, Wong N, Wu W, Noguera V, Li M, Semple J. Surgical safety checklist: implementation in an ambulatory surgical facility. Can J Anaesth. 2013 Jun;60(6):528-38. doi: 10.1007/s12630-013-9916-8. Epub 2013 Mar 16.

MeSH Terms

Conditions

Postoperative ComplicationsCommunication

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Pamela J Morgan, MD

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pamela J Morgan

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 8, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

April 1, 2012

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations