InjuriesNCT06195631

Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy

A study testing Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle in people with Injuries, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Injuries
What is being tested?: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Jan 2026to Feb 2027
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Endoscopists-in-training will be excluded as will endoscopy units that do not have adjustable monitors and patient beds

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

Read the 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.

Conditions: Injuries
Being tested: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle
Keywords: Ergonomics, Endoscopy related injury ( ERI), Checklist
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) BundleBehavioural
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.

Study groups in NCT06195631
Study group	Role	What they receive
Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle	Experimental	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. Receives: Behavioral: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle
Standard of practice	No 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Month 3

Secondary outcomes (8)

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
Measured: Month 3
Reach - Number of endoscopists per unit who consent to participate
Number of endoscopists per unit who consent to participate.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2026Feb 2027

First posted8 Jan 2024
Study startJan 2026 (estimated)
Primary completionFeb 2027 (estimated)
Study completionFeb 2027 (estimated)

Why it stopped: Study had not been IRB approved, no one took over the study, and PI moved to another institution.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06195631
Sponsor's protocol ID: PAWA SCOPE-E Bundle
Status last verified: Aug 2025
First submitted: 22 Dec 2023
Last updated: 12 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the SCOPE-E Bundle, a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy: An Effectiveness-Implementation Cluster Randomized Trial
ClinicalTrials.gov ID: NCT06195631
Acronym / sponsor ID: PAWA SCOPE-E Bundle
Conditions: Injuries
Keywords: Ergonomics, Endoscopy related injury ( ERI), Checklist
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study had not been IRB approved, no one took over the study, and PI moved to another institution.
Enrolment: 0 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: Jan 2026 (estimated)
Primary completion: Feb 2027 (estimated)
Study completion: Feb 2027 (estimated)
First posted: 8 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle	Experimental	Behavioral: Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) BundleEndoscopists 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.
Standard of practice	No 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 may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Endoscopists-in-training will be excluded as will endoscopy units that do not have adjustable monitors and patient beds

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) BundleThe 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.	Behavioural	Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE- E) Bundle

Primary outcome

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)
Time frame: 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

8 secondary outcomes

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).
Time frame: Month 3
Reach - Number of endoscopists per unit who consent to participate
Time frame: Month 3
Adoption - Percentage of colonoscopies
Time frame: Baseline and Month 3
Feasibility - time taken to complete the endoscopy ergonomic timeout
Time frame: Month 3
Fidelity - Rate of inclusion of all checklist components in the pre-endoscopy timeout
Time frame: Month 3
Acceptability - Survey Score
Time frame: Month 3
Adaptation - Survey Score
Time frame: Month 3
Sustainability - Survey Score
Time frame: Month 3

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pawa Swati, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06195631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.