Introduction of the Surgical Safety Checklist

NCT ID: NCT00934310

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ambulatory surgical patient

Exclusion Criteria

* in-patient or any patient who is planning to be admitted to hospital postoperatively
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Women's College Hospital

OTHER

Sponsor Role collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pamela J. Morgan

Dr. Pamela J Morgan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pamela J Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23504355 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-0017-E

Identifier Type: -

Identifier Source: org_study_id