Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy

NCT ID: NCT06195631

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-02-28

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.

Conditions

Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle

Intervention Type: BEHAVIORAL

The SCOPE-E bundle is a multicomponent intervention designed to improve endoscopy ergonomics. The bundle is composed of one core intervention and 5 evidence-based implementation strategies which are defined as methods to enhance the adoption, implementation and sustainment of the core intervention. The core intervention is a pre-endoscopy ergonomic time-out checklist. The implementation strategies are endoscopist education, checklist documentation, visual reminders, nursing engagement and leadership support.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle

The SCOPE-E bundle is a multicomponent intervention designed to improve endoscopy ergonomics. The bundle is composed of one core intervention and 5 evidence-based implementation strategies which are defined as methods to enhance the adoption, implementation and sustainment of the core intervention. The core intervention is a pre-endoscopy ergonomic time-out checklist. The implementation strategies are endoscopist education, checklist documentation, visual reminders, nursing engagement and leadership support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Endoscopists-in-training will be excluded as will endoscopy units that do not have adjustable monitors and patient beds

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pawa Swati, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

PAWA SCOPE-E Bundle

Identifier Type: -

Identifier Source: org_study_id