Clinical trial NCT06195631: Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy
Official title: Evaluating the SCOPE-E Bundle, a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy: An Effectiveness-Implementation Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Injuries
Keywords: Ergonomics
Endoscopy related injury ( ERI)
Checklist
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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)
timeFrame: Month 3
Secondary outcomes:
measure: 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).
timeFrame: Month 3
measure: Reach - Number of endoscopists per unit who consent to participate
timeFrame: Month 3
measure: Adoption - Percentage of colonoscopies
timeFrame: Baseline and Month 3
measure: Feasibility - time taken to complete the endoscopy ergonomic timeout
timeFrame: Month 3
measure: Fidelity - Rate of inclusion of all checklist components in the pre-endoscopy timeout
timeFrame: Month 3
measure: Acceptability - Survey Score
timeFrame: Month 3
measure: Adaptation - Survey Score
timeFrame: Month 3
measure: Sustainability - Survey Score
timeFrame: Month 3
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Pawa Swati, MD
role: PRINCIPAL_INVESTIGATOR
References: