Impact on Diagnostic Accuracy of a Specific Clinical Ultrasound Practical Teaching

NCT04879459 | Completed

• 1 other identifier: CUS gallbladder
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research proposal is a pilot double-blind randomized control trial evaluating the impact on diagnostic accuracy of a Clinical UltraSound (CUS) teaching for gallbladder assessment using exclusively healthy volunteers for practical sessions. Classically, a number of 25 to 50 CUS of the gallbladder is reported to achieve competency. Many CUS curricula or guidelines recommend reporting pathological cases, either a certain amount, either generically, in their core-ultrasound competency requirements. Using healthy volunteers is rarely meant to verify the hypothesis that practical sessions based on exclusively normal patterns combined with presentation of pathological ultrasound loops or images during theoretical sessions, could further allow reaching diagnostic accuracy requirements in clinical practice. In the present study, participants will be medical students in their 5th year, naïve to CUS use. Participants will be randomly be distributed between a control group undergoing a standard practical teaching on models presenting uncomplicated gallstones or normal gallbladder (no gallstones), and an intervention group undergoing a practical teaching exclusively on models presenting a normal gallbladder. Participants will be "blinded" to study endpoints as well as to group allocation. After three days of practical teaching on day 0-10-30, students will be evaluated on day 60 by 2 external investigators blinded to students group allocation. Diagnostic accuracy for gallstones will be measured using sensitivity and specificity. Statistical analysis will be performed blinded to students' name using IBM SPSS statistics 26.0 (SPSS Inc., Chicago, IL, USA). As is classical, the statistical tests will be rejected whenever the observed p-value is smaller than 0.05. Corrections for multiple testing will be used. A comparable diagnostic accuracy between groups could further support the use of healthy volunteers during practical teaching and ease clinical ultrasound curricula. Such a finding wouldn't however carry away the need for enhancing competencies during clinical practice or the need for continuing medical education, as for any medical procedure.

Conditions

Gallstone

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy for gallstones according to practical teaching (IG or CG)

  sensitivity and specificity for gallstones diagnosis

  Each participants will be evaluated at day 60 during a session of 20 minutes using volunteers for clinical ultrasound of the gallbladder

Secondary Outcomes (4)

• Difference betweeen pre-test and post-test results

  Each participants will be evaluated at day 60 during a session of 20 minutes using volunteers for clinical ultrasound of the gallbladder

• Confidence index for gallstones' diagnosis between Control Group (CG) and Intervention Group (IG).

  Each participants will be evaluated at day 60 during a session of 20 minutes using volunteers for clinical ultrasound of the gallbladder

• Time to get CUS image between CG and IG

  Each participants will be evaluated at day 60 during a session of 20 minutes using volunteers for clinical ultrasound of the gallbladder

• Quality of the image between CG and IG

  Each participants will be evaluated at day 60 during a session of 20 minutes using volunteers for clinical ultrasound of the gallbladder

Study Arms (2)

Intervention Group IG

The IG is constituted of participants, naïve to ultrasound use. Participants undergo a web-based video learning about gallbladder evaluation using CUS on day 0 (same video as in CG). Participants undertake 3 times a one-day CUS course consisting in 2 practical sessions of 10 times 10 minutes on 10 healthy volunteers on day 0, day 7 and day 10. One practical session takes place before lunchtime, the second one after lunchtime. Participants of IG don't have any contact with CG during study days. An evaluation is organized on day 60 to evaluate primary and secondary endpoints.

Other: Practical sessions to learn CUS exclusively on volunteers presenting a healthy gallbladder

Control Group CG

The CG is constituted of participants, naïve to ultrasound use. Participants undergo a web-based video learning about gallbladder evaluation using CUS on day 0. Participants of CG undertake 2 practical CUS sessions of 10 times 10 minutes on 10 volunteers, at least 50% of them suffering from gallstones on day 0, day 7 and day 10. One session takes place before lunchtime, the second one after lunchtime. Participants of CG don't have any contact with IG during study days. An evaluation is organized on day 60 to evaluate primary and secondary endpoints.

Interventions

Practical sessions to learn CUS exclusively on volunteers presenting a healthy gallbladder OTHER

The study days are 1 day apart for CG and IG but follow the exact same organization. Studytake place on day 0-10-30 (+/-2days). Practical sessions to learn CUS are organized either on volunteers presenting a healthy gallbladder or a pathological gallbladder (sludge, gallstones) (CG), either exclusively on volunteers presenting a healthy gallbladder (IG).

Intervention Group IG

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical students →Participants An e-mail invitation is send three times over a two weeks period for participants enrollment. Participants are selected among medical students in their 5th year (Master 2). If e-mail is not sufficient, participants are invited during a medical course given in Université Catholique de Louvain. Medical students are invited to answer to a questionnaire defining their CUS use status (naïve or not) to assess for eligibility.

You may qualify if:

• ≥ 18 years of age
• th year medical students
• Considered naïve to CUS
• Signed consent and signed non-disclosure agreement obtained

You may not qualify if:

• Unable to use CUS due to a disability
• Prior CUS skills
• Unable to use CUS due to a new disability
• Unable to complete the four study days
• Breach of "non disclosure agreement"

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires saint luc

Brussels, 1200, Belgium

Location

Related Publications (16)

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Related Links

• Credentialing For Emergency Medicine Ultrasonography

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Vanpee, PhD

  Institut de recherche santé et société

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 10, 2021
• Study Start: October 12, 2021
• Primary Completion: December 11, 2021
• Study Completion: December 11, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)