Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Injuries
• Intervention / Treatment: Behavioral: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	Month 3
Reach - Number of endoscopists per unit who consent to participate	Number of endoscopists per unit who consent to participate.	Month 3
Adoption - Percentage of colonoscopies	Percentage of colonoscopies where a pre-endoscopy ergonomic timeout is completed over a 1-week period pre- and 3-months post intervention initiation.	Baseline and Month 3
Feasibility - time taken to complete the endoscopy ergonomic timeout	Mean time taken to complete the endoscopy ergonomic timeout, measured over 1-week period 3-months post-intervention initiation.	Month 3
Fidelity - Rate of inclusion of all checklist components in the pre-endoscopy timeout	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.	Month 3
Acceptability - Survey Score	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	Month 3
Adaptation - Survey Score	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	Month 3
Sustainability - Survey Score	Intention to continue implementation beyond study period (numerical rating, source: post- survey). Scores range from 0-7 with higher scores meaning more sustainability	Month 3

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Pawa Swati, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ergonomics; Checklist; Endoscopy related injury ( ERI)
• Additional Relevant MeSH Terms: Wounds and Injuries; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy
• Other Study ID Numbers: PAWA SCOPE-E Bundle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No