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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special checklist can reduce the risk of injuries during colonoscopies. The checklist, called the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) Bundle, helps doctors ensure ergonomic setup before starting the procedure, reducing strain and potential injury. The trial includes two groups: one using the checklist and one following usual procedures. Endoscopists who perform colonoscopies at least once a week and have the necessary equipment are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to enhancing safety and outcomes in medical procedures.

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 prior data suggests that the SCOPE-E bundle is safe for reducing injury during colonoscopy?

Research has shown that using checklists, like the SCOPE-E bundle, can be safe and effective. The World Health Organization found that safety checklists improve procedure outcomes and reduce mistakes, making procedures safer by preventing errors.

The SCOPE-E bundle includes a checklist used before a colonoscopy to ensure proper posture and movement, designed to prevent endoscopy-related injuries. The checklist prompts doctors to pause and confirm they are using best practices to avoid strain and injury for both the patient and the doctor.

No reports have linked problems directly to using these checklists. They are generally well-accepted for guiding safe practices in existing procedures, suggesting a low risk for participants considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SCOPE-E Bundle because it introduces an innovative approach to reducing injuries during colonoscopy by focusing on procedural ergonomics. Unlike the usual practice, which doesn't emphasize ergonomics, this method uses a standardized checklist to guide endoscopists in performing a verbal time-out before each procedure. This proactive step aims to enhance safe practices and potentially improve outcomes by minimizing physical strain and the risk of injury, which is not typically addressed in standard colonoscopy protocols.

What evidence suggests that the SCOPE-E bundle is effective for reducing endoscopy-related injuries during colonoscopy?

This trial will compare the use of the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) Bundle with standard practice during colonoscopy procedures. Research has shown that a checklist like the SCOPE-E bundle can reduce injuries by emphasizing proper body positioning and movement. Studies indicate that good body mechanics can lower the risk of strain and injury for medical staff. The checklist includes a pause before the procedure to ensure everyone uses safe techniques. Guidelines from the American Society for Gastrointestinal Endoscopy support this method, highlighting the importance of body positioning in preventing injuries. Early findings suggest these strategies could enhance safety for both the patient and the medical team during colonoscopy. ^{1 2 3 4 6}

Who Is on the Research Team?

Pawa Swati, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/420832?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Evaluating a Standardized Checklist Bundle for Optimizing... To bridge this gap, the aim is to evaluate the effectiveness and implementation of the Standardized Checklist for Optimizing Procedural ...

2. withpower.com withpower.com/trial/phase-injury-3-2024-2701c

Checklist Bundle for Reducing Injury During Colonoscopy The goal of this Hybrid Type 2 effectiveness-implementation trial is to test the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy ...

3. asge.org asge.org/docs/default-source/guidelines/asge-guideline-on-the-role-of-ergonomics-summary.pdf

asge-guideline-on-the-role-of-ergonomics-summary.pdf This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence- based approach to strategies to prevent ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/den.14999

Ergonomic endoscopy – Fundamentals of ... This review discusses problematic endoscopic tasks from an ergonomic perspective, issues with MSD definitions, the prevalence of MSDs, local site ...

5. cghjournal.org cghjournal.org/article/S1542-3565(23)00083-6/fulltext

Integrating Ergonomics into Endoscopy Training: A Guide ... An ergonomic checklist (inset) can be used to guide a suggested pre-endoscopy ergonomic time-out. Modified from Tiffany S. Davanzo, MA, CMI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10302307/

Implementation of a Customized Safety Checklist in ... According to the World Health Organization, the implementation of customized safety checklists can improve procedural outcomes and reduce human ...