Injuries
Conditions
Keywords
Ergonomics, Endoscopy related injury ( ERI), Checklist
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.
Interventions
BEHAVIORALStandardized 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Month 3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach - Number of endoscopists per unit who consent to participate | Month 3 | Number of endoscopists per unit who consent to participate. |
| Adoption - Percentage of colonoscopies | Baseline and Month 3 | Percentage of colonoscopies where a pre-endoscopy ergonomic timeout is completed over a 1-week period pre- and 3-months post intervention initiation. |
| Feasibility - time taken to complete the endoscopy ergonomic timeout | Month 3 | Mean time taken to complete the endoscopy ergonomic timeout, measured over 1-week period 3-months post-intervention initiation. |
| 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). | Month 3 | 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 |
| Acceptability - Survey Score | Month 3 | 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 |
| Adaptation - Survey Score | Month 3 | 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 |
| Sustainability - Survey Score | Month 3 | Intention to continue implementation beyond study period (numerical rating, source: post- survey). Scores range from 0-7 with higher scores meaning more sustainability |
| Fidelity - Rate of inclusion of all checklist components in the pre-endoscopy timeout | Month 3 | 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. |
Countries
United States
Outcome results
None listed