The Surgical Safety Checklist Revisited

January 19, 2024 updated by: University of Calgary

Adaptation of the World Health Organization Surgical Safety Checklist to High-Income Healthcare Settings - Phase III: Site Testing Study

The goal of this study is to develop and iteratively improve a toolkit - the "High-Performance Checklist" (HPC) toolkit - that provides clinicians with evidence-informed strategies for improving their Modification, Implementation, Training on, and Evaluation of the Surgical Safety Checklist.

The study team will test the toolkit in the operating rooms of Calgary's Peter Lougheed Centre and collect feedback via surveys and questionnaires. This feedback will be used to iteratively improve the toolkit.

By improving clinicians' ability to modify their SSC, the study team hopes to see improvements in its uptake and surgical outcomes for patients.

Participants will be surgical clinical staff members and hospital administration, as well as participants over the age of 18, who have undergone a surgery in the last 90 days. They will all complete the following tasks:

Online or paper questionnaire Semi structured interviews Team meetings

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is the third phase of a multi-year, multi-stage research project aimed at successful use of the World Health Organization's Safe Surgery Checklist. The study's first stage involved collecting perceptions of the SSC from surgical personnel in five high-income countries: Australia, the United States, Canada, the United Kingdom, and New Zealand. In that stage, interviews and surveys were conducted with individuals who use the SSC. Our results showed barriers and facilitators to the SSC's use and highlighted clinicians' attitudes towards it. The first stage of our study identified the need to better tailor the SSC checklists to meet contextual needs and ongoing gaps in leadership and team performance.

The study's second stage involved building a toolkit aimed at addressing four areas (Modification, Implementation, Training, and Evaluation) through the creation of working groups for each area. These working groups comprised Subject-Matter Experts (SMEs) from the consensus meeting and individuals from the surgical safety field. The output generated by these groups through a consensus-building process is the "High-Performance Checklist" Toolkit ("Toolkit"). The Toolkit is built using the Explore, Prepare, Implement, and Sustain (EPIS) framework and provides clinicians a mechanism for effectively customizing their SSC to their needs.

The third stage of the study involves pilot testing the Toolkit at three different sites and assessing its impact and usefulness in helping implementation teams at these sites. The three sites selected for this study are facilities of different size and scale, for which impact, outcomes, and clinician feedback from Implementation Teams from each site will be compared. The first site is the Peter Lougheed Centre in Calgary, Alberta, then the team intend to run the study at the University of Alberta Hospital and the hospital in Fort McMurray, Alberta.

At each site, three types of participants will be recruited: Implementation team ("ImT") members, operating room ("OR") personnel, and surgical patients. The ImT members will work through the Toolkit to customize their SSC, then the OR personnel will use the modified SSC. The patients will participate in Focus Groups to explore their perceptions of the SSC's use at each site.

From there, we will endeavour to make alterations to the toolkit, if necessary, before rolling it out on a larger scale.

The anticipated result is that clinicians' use of this toolkit will enhance their ability to effectively modify, implement, train, and evaluate their SSC, improve their use of SSC to reduce the rate of adverse events with patients in the OR. It is predicted that the Toolkit will have a positive impact on the culture of patient safety and staff members' perception of psychological safety in the OR.

This study aims to fill the gap in effective checklist modification, training, implementation, and evaluation that was observed during data gathering stage. The study team will gain insight on the utility of a tool designed for improving surgical teams' use of the SSC: how it works, users' perceptions of it, areas for improvement, and ideas for spreading the tool's usage.

Methods: During this stage of the study, the Toolkit will be implemented at the aforementioned Albertan sites. Using an effectiveness-implementation hybrid design, a mixed-methods approach will be applied to assess the implementation of the Toolkit and users' experiences with it. The impact of the toolkit's use on clinical outcomes will also be assessed through the collection of health systems data. Through a series of surveys, interviews, and observations of the toolkit being used, the toolkit's usability, feasibility, and acceptability, and impact on safety culture will be measured before, during, and after the toolkit's implementation. Throughout the study, ratings of the SSC's performance will be taken to assess the toolkit's impact on OR participants' teamwork and SSC engagement.

Operationally, this stage of the study comprises four phases: initial introductions and pre-study data collection, use of the Toolkit by completing the EPIS elements, post-implementation data collection, and a three-months post-implementation follow-up. Data will be collected during each phase to assess the impact of the toolkit and the experience of its users.

Data analysis: survey, health systems data, and SSC performance ratings will be analyzed using SPSS and qualitative data from the observations and interviews will be analyzed thematically using NVIVO.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 1L1
        • Recruiting
        • Karolina Kogut
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mary Brindle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

There are three types of participants in this study:

  1. The Implementation Team includes physicians, nurses, administrators, and patient advocates
  2. The OR Team
  3. Surgical patients

Description

Inclusion Criteria:

  • surgeons, anesthesiologists, nurses and administrator will be included in the study
  • surgical patients that have undergone surgery within the last three months at the Peter Lougheed Centre

Exclusion Criteria:

  • Patients that are unable to fill out a survey or participate in a semi structured interview
  • Patients that surgery was done more than 3 months ago
  • Surgical patients that are under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Implementation Team

The Implementation Group will complete two surveys at the beginning of the study, then at five different points during the HPC Toolkit's use, and again three months post-intervention. The surveys are the Safe Surgery Checklist Culture Survey and the SSC Use and Attitudes Survey and a series of user experience surveys.

They will also do interviews pre- and post-HPC toolkit, and we will observe the Implementation Team's meetings as they work through the toolkit.
OR Team
The OR members will complete the same pre- and post-intervention surveys (Safe Surgery Checklist Culture Survey and the SSC Use and Attitudes Survey) and do interviews before and after the IT has worked through the HPC toolkit.
Surgical Patients
Surgical patients will be invited to participate in focus groups on their experiences from the time they enter the hospital on the day of their surgery to the moment they are put under anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of the HPC Toolkit
Time Frame: the initial 8 weeks of interacting with the study site
We will assess if the clinicians use of the HPC toolkit foster improvement in their use of the SSC. Surveys and semi-structured interviews will be collected at baseline, after the HPC introduction and at follow-up to assess if the HPC toolkit is sustained.
the initial 8 weeks of interacting with the study site
Reduction rate of adverse events in patient
Time Frame: Through study completion, and average of 1 year
We will assess if the clinicians use of the HPC toolkit reduces the rate of adverse events in patients
Through study completion, and average of 1 year
SSC Attitudes and OR Culture
Time Frame: Approximately the first and last 8 weeks interacting with the study site.
The Implementation Team ("ImT") and OR Team's perceptions of the SSC and OR Culture will be measured through surveys at3 points in time.
Approximately the first and last 8 weeks interacting with the study site.
Patient Surgical Experiences Survey
Time Frame: Approximately the first and last 8 weeks interacting with the study site.
Patients' experiences with surgery before and after the HPC Toolkit's implementation.
Approximately the first and last 8 weeks interacting with the study site.
User Experience Surveys
Time Frame: Approximately the first and last 8 weeks interacting with the study site
The ImT's experiences with the HPC Toolkit: ease of use, intuitiveness, layout, etc.
Approximately the first and last 8 weeks interacting with the study site
CheckPOINT observation tool
Time Frame: Approximately the first and last 8 weeks interacting with the study site
In situ observations of the SSC's use in the OR; measures SSC use in practice. Captured by the ImT and OR Team participants.
Approximately the first and last 8 weeks interacting with the study site
Semi-structured interviews
Time Frame: Approximately the first and last 8 weeks interacting with the study site
Participants' perceptions of the SSC and the HPC Toolkit's impact on it
Approximately the first and last 8 weeks interacting with the study site
Meeting observations
Time Frame: up to 16 weeks
The Implementation Team's use of the HPC Toolkit
up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare system data collection
Time Frame: Up to 2 years
AHS data analytics will be collected to assess the HPC toolkit's impact on patient safety and clinical throughput.
Up to 2 years
Measures of surgical safety
Time Frame: Up to 2 years
Health systems data will be collected to look at the following perioperative events:a. Surgical Site Infection Rate (%) b. 30-Day In Hospital Mortality after major surgery (crude and risk adjusted) c. 30-Day re-admission after surgery (crude rate and risk adjusted rate) d. Unplanned ED visit within 30 days after surgery (%) e. Unplanned Re-Operative events (%) - within 24 hours? f. Peri-operative venous thromboembolism (VTE) diagnosis (%)
Up to 2 years
Effectiveness of SSC practice
Time Frame: Up to 2 years
Errors averted by using the safe Surgery Checklist (Provincial Data):a. Site/Side/Location/Procedure - Incomplete or incorrect b. Pre op prep/lab/meds - incomplete or incorrect c. Equipment/Supplies - Missing or incorrect d. Allergies/Contraindications - to medication/equipment e. Documentation/history - incomplete or incorrect f. Wrong patient g. Not specified These data will be collected before and after implementation of the High Performance Toolkit to demonstrate the effectiveness of SSC practice.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)
Ariadne Labs
National Aeronautics and Space Administration (NASA)

Investigators

  • Principal Investigator: Mary Brindle, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB21-0099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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