Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy
- Conditions
- Injuries
- Interventions
- Behavioral: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle
- Registration Number
- NCT06195631
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Endoscopists-in-training will be excluded as will endoscopy units that do not have adjustable monitors and patient beds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle 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.
- Primary Outcome Measures
Name Time Method 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) 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
- Secondary Outcome Measures
Name Time Method Reach - Number of endoscopists per unit who consent to participate Month 3 Number of endoscopists per unit who consent to participate.
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 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
Adoption - Percentage of colonoscopies Baseline and Month 3 Percentage of colonoscopies where a pre-endoscopy ergonomic timeout is completed over a 1-week period pre- and 3-months post intervention initiation.
Feasibility - time taken to complete the endoscopy ergonomic timeout Month 3 Mean time taken to complete the endoscopy ergonomic timeout, measured over 1-week period 3-months post-intervention initiation.
Acceptability - Survey Score Month 3 Endoscopists' and nurses ± technicians' perceived acceptability of the SCOPE-E bundle (numerical rating, data source: post-implementation survey. Scores range from 0-7 with higher scores meaning more acceptance
Fidelity - Rate of inclusion of all checklist components in the pre-endoscopy timeout Month 3 Rate of inclusion of all checklist components in the pre-endoscopy timeout, number and source of interruptions during timeout, and rate of checklist documentation, measured over 1-week period 3-months post-intervention initiation.
Adaptation - Survey Score Month 3 Self-reported adaptations by endoscopists to make the SCOPE-E bundle fit to their context (qualitative data, data source: post-implementation survey).Scores range from 0-7 with higher scores meaning more adaptation
Sustainability - Survey Score Month 3 Intention to continue implementation beyond study period (numerical rating, source: post- survey). Scores range from 0-7 with higher scores meaning more sustainability
Trial Locations
- Locations (1)
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States