Evaluating the SCOPE-E Bundle, a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy: An Effectiveness-Implementation Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in mean Rapid Entire Body Assessment (REBA) scores during colonoscopy between groups (intervention and control) - assessed using ErgoGENIUS (an artificial intelligence posture analysis program)
研究概览
简要总结
The goal of this Hybrid Type 2 effectiveness-implementation trial is to test the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) bundle-a multicomponent intervention comprised of a pre-procedure ergonomic timeout checklist and evidence-based implementation strategies-as a strategy to mitigate the risk of Endoscopy-related injuries (ERI) during colonoscopy.
详细描述
Endoscopy-related injuries (ERI) occur frequently, emphasizing the crucial need to integrate ergonomic principles into endoscopic practice to mitigate risks and prioritize the health and well-being of endoscopists. Checklists are a proven strategy in healthcare behavior modification; however, the efficacy of a pre-procedure ergonomic timeout checklist remains underexplored. To bridge this gap, the aim is to evaluate the effectiveness and implementation of the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) bundle-a multicomponent intervention comprised of a pre-procedure ergonomic timeout checklist and evidence-based implementation strategies-as a strategy to mitigate the risk of ERI during colonoscopy.
Conducted will be a Hybrid Type 2 cluster randomized controlled trial across 10 endoscopy units in North America with 100 participants. Units will be randomized to the SCOPE-E bundle or usual practice. Effectiveness will be measured by comparing Rapid Entire Body Assessment (REBA) scores before and 3 months after implementation between intervention and control groups. Simultaneously, implementation outcomes will be assessed to understand the practicality of this ergonomic intervention and inform widescale adoption. If demonstrated to be effective, the SCOPE-E Bundle is a feasible and cost-effective intervention that holds significant promise for improving ergonomics globally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Endoscopists who perform colonoscopy at least once per week at one of the participating endoscopy units and who are willing to sign an informed consent form before any study procedures are performed
排除标准
- •Endoscopists-in-training will be excluded as will endoscopy units that do not have adjustable monitors and patient beds
研究组 & 干预措施
Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle
Endoscopists in each unit that is randomized to the intervention will be asked to use an ergonomic check list to conduct a verbal time-out before commencing each colonoscopy procedure.
干预措施: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle (Behavioral)
Standard of practice
Usual practice does not involve any of the core components of the SCOPE-E bundle. Endoscopy units in the control arm will not undergo any targeted intervention(s) to enhance ergonomic behaviors throughout the study period.
结局指标
主要结局
Difference in mean Rapid Entire Body Assessment (REBA) scores during colonoscopy between groups (intervention and control) - assessed using ErgoGENIUS (an artificial intelligence posture analysis program)
时间窗: Month 3
REBA, a validated measure of entire body ergonomics which considers joint positioning, force exertion, repetitive movements and postural shifts, is a surrogate for Endoscopic Related Injury (ERI) risk. The minimum REBA Score = 1, and the maximum REBA Score = 15. The design goal for the REBA assessment is a score of 4
次要结局
- Reach - Number of endoscopists per unit who consent to participate(Month 3)
- Difference in the percentage of time endoscopists spend during colonoscopy in postures at medium, high or very high risk of ERI (i.e., REBA score >4).(Month 3)
- Adoption - Percentage of colonoscopies(Baseline and Month 3)
- Feasibility - time taken to complete the endoscopy ergonomic timeout(Month 3)
- Acceptability - Survey Score(Month 3)
- Fidelity - Rate of inclusion of all checklist components in the pre-endoscopy timeout(Month 3)
- Adaptation - Survey Score(Month 3)
- Sustainability - Survey Score(Month 3)