Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195631
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-12-22
Brief Title:
Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Evaluating the SCOPE-E Bundle a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy An Effectiveness-Implementation Cluster Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None