The Surgical Safety Checklist Revisited

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700890
• Other study ID #: REB21-0099
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: University of Calgary
• Contact: Karolina Kogut
• Phone: 4034611190
• Email: kkogut[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Locations

Country	Name	City	State
Canada	Karolina Kogut	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Ariadne Labs, Canadian Institutes of Health Research (CIHR), National Aeronautics and Space Administration (NASA)

Country where clinical trial is conducted

Canada, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of the HPC Toolkit	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
Primary	Reduction rate of adverse events in patient	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
Primary	SSC Attitudes and OR Culture	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.
Primary	Patient Surgical Experiences Survey	Patients' experiences with surgery before and after the HPC Toolkit's implementation.	Approximately the first and last 8 weeks interacting with the study site.
Primary	User Experience Surveys	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
Primary	CheckPOINT observation tool	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
Primary	Semi-structured interviews	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
Primary	Meeting observations	The Implementation Team's use of the HPC Toolkit	up to 16 weeks
Secondary	Healthcare system data collection	AHS data analytics will be collected to assess the HPC toolkit's impact on patient safety and clinical throughput.	Up to 2 years
Secondary	Measures of surgical safety	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
Secondary	Effectiveness of SSC practice	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