Checklist Bundle for Reducing Injury During Colonoscopy

Overseen By Swati Pawa, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Endoscopists-in-training, Non-adjustable equipment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) Bundle?

Research shows that educational interventions focusing on ergonomics can reduce musculoskeletal pain and injuries for endoscopists, which suggests that the SCOPE-E Bundle may help prevent injuries during colonoscopy by improving ergonomic practices. ^{1 2 3 4 5}

Is the SCOPE-E Bundle safe for use in humans?

Research suggests that improving ergonomics in endoscopy, like with the SCOPE-E Bundle, can reduce the risk of musculoskeletal injuries for staff, which may also benefit patient safety during procedures. ^{1 2 3 4 6}

How does the checklist bundle treatment for reducing injury during colonoscopy differ from other treatments?

The checklist bundle treatment is unique because it focuses on using a structured checklist to improve communication and safety during colonoscopy procedures, rather than relying on medication or surgical techniques. This approach aims to prevent errors and enhance patient safety by ensuring all necessary steps are followed before and during the procedure. ^{5 7 8 9 10}

What is the purpose of this 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.

Research Team

Pawa Swati, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for endoscopists who regularly perform colonoscopies at least weekly in participating units and are willing to consent to study procedures. It excludes those still in training or working in units without adjustable monitors and beds.

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

Endoscopy units that do not have adjustable monitors and patient beds

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the SCOPE-E bundle, including a pre-procedure ergonomic timeout checklist

3 months

Regular visits for implementation assessment

Evaluation

Evaluation of the effectiveness of the SCOPE-E bundle using REBA scores and other measures

3 months

Visits for data collection and evaluation

Follow-up

Participants are monitored for sustainability and adaptation of the SCOPE-E bundle

1 month

Treatment Details

Interventions

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

Trial Overview The trial tests the SCOPE-E bundle, which includes a pre-procedure checklist aimed at improving ergonomic practices during colonoscopy to prevent injuries related to the procedure.

Participant Groups

Group I: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle Experimental Treatment 1 Intervention

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 II: Standard of practice Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Educational interventions to improve ergonomics in gastrointestinal endoscopy: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Does Manual Abdominal Pressure During Colonoscopy Put Endoscopy Staff and Patients at Risk? Experiences of Endoscopy Nurses and Technicians. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ergonomic endoscopy: An oxymoron or realistic goal? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of a simulation-based ergonomics training curriculum on work-related musculoskeletal injury risk in colonoscopy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Person-centered endoscopy safety checklist: Development, implementation, and evaluation. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Difficult colonoscopies in the propofol era. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Implementation of a checklist before colonoscopy: a quality improvement initiative. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Troubleshooting common endoscopic malfunctions: a study integrating a preoperative checklist and troubleshooting guide into surgical resident training. [2018]

9. Brazil pubmed.ncbi.nlm.nih.gov

Safe prone checklist: construction and implementation of a tool for performing the prone maneuver. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety Bundles in Gynecology. [2020]