Adaptation of the World Health Organization Surgical Safety Checklist to High-Income Healthcare Settings - Phase III: Site Testing Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- SSC Attitudes and OR Culture
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
SSC Attitudes and OR Culture
时间窗: 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.
Perception of the HPC Toolkit
时间窗: 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.
Patient Surgical Experiences Survey
时间窗: Approximately the first and last 8 weeks interacting with the study site.
Patients' experiences with surgery before and after the HPC Toolkit's implementation.
Reduction rate of adverse events in patient
时间窗: 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
Meeting observations
时间窗: up to 16 weeks
The Implementation Team's use of the HPC Toolkit
User Experience Surveys
时间窗: 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.
CheckPOINT observation tool
时间窗: 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.
Semi-structured interviews
时间窗: 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
次要结局
- Healthcare system data collection(Up to 2 years)
- Measures of surgical safety(Up to 2 years)
- Effectiveness of SSC practice(Up to 2 years)