Clinical trial NCT05700890: The Surgical Safety Checklist Revisited
Official title: Adaptation of the World Health Organization Surgical Safety Checklist to High-Income Healthcare Settings - Phase III: Site Testing Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Procedure, Unspecified
Communications Personnel
Tool Use Behavior
Keywords: Surgical Safety Checklist
Patient Safety
Quality improvement
Teamwork
Psychological safety
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ariadne Labs
name: National Aeronautics and Space Administration (NASA)
First posted: 2023-01-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perception of the HPC Toolkit
timeFrame: the initial 8 weeks of interacting with the study site
measure: Reduction rate of adverse events in patient
timeFrame: Through study completion, and average of 1 year
measure: SSC Attitudes and OR Culture
timeFrame: Approximately the first and last 8 weeks interacting with the study site.
measure: Patient Surgical Experiences Survey
timeFrame: Approximately the first and last 8 weeks interacting with the study site.
measure: User Experience Surveys
timeFrame: Approximately the first and last 8 weeks interacting with the study site
measure: CheckPOINT observation tool
timeFrame: Approximately the first and last 8 weeks interacting with the study site
measure: Semi-structured interviews
timeFrame: Approximately the first and last 8 weeks interacting with the study site
measure: Meeting observations
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Healthcare system data collection
timeFrame: Up to 2 years
measure: Measures of surgical safety
timeFrame: Up to 2 years
measure: Effectiveness of SSC practice
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Karolina Kogut
state: Alberta
Study officials:
affiliation: University of Calgary
name: Mary Brindle, MD
role: PRINCIPAL_INVESTIGATOR
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