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Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy

Injuries Clinical Trial

Official title:
Evaluating the SCOPE-E Bundle, a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy: An Effectiveness-Implementation Cluster Randomized Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06195631
Study type Interventional
Source Wake Forest University Health Sciences
Contact Swati Pawa, MD
Phone 248-505-3037
Email spawa@wakehealth.edu
Status Not yet recruiting
Phase N/A
Start date September 2024
Completion date April 2026
View Details
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