Digital Rectal Exam Proficiency Tool

Prostate Cancer Clinical Trial

— DiRECT  

Official title:

Validation of the DiRECT Proficiency Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02278679
• Other study ID #: 17658
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2014
• Last updated: May 17, 2017
• Start date: October 2014
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: University of Virginia
• Contact: Tracey L Krupski, M.D.
• Phone: 434-924-0042
• Email: tlk6t[@]virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A digital rectal exam proficiency tool, titled the 'DiRECT' was developed based on the consensus of 10 experts. The purpose of this study is to validate this tool for use in both undergraduate and graduate medical education .

Description:

First, it will be validated on 120 anesthetized patients undergoing prostate surgery, comparing responses on the digital rectal exam clinical tool (DiRECT) from both expert and novice clinicians, with surgical pathology reports. The second phase of validation will involve the participation of standardized patients, medical students and MUTA (medical urology teaching associate). During a standardized patient exercise focusing on digital rectal exam in the University of Virginia School of Medicine curriculum, 160 second-year medical students will be given the DiRECT to document their examination. An attending physician will also attend the standardized patient exercise and document their examination for comparison with the medical students.

The third phase includes 8 residents and up to10 attendings in the Urology clinic, who will independently complete the DiRECT documenting their DRE in the course of usual care.

Comparison of faculty and student/trainee responses in all phases will be used for validation of the clinical tool for further use in medical education.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

Subjects who are patients:

• Patients who are male and adults = 30 years of age

• Standardized patients between the ages of 30-80 years participating in the University of Virginia School of Medicine activity for second-year students learning digital rectal exams

Subjects who are clinicians:

• Attending physician, resident physician, or medical student scrubbed in for a prostatectomy or cystectomy, seeing patients in urology clinic, or participating in the School of Medicine activity for second year students learning digital rectal exams

Exclusion Criteria:

List the criteria for exclusion

• Patients who do not have a prostate

• Patients with previous pelvic/perineal surgery

• Previously enrolled in this study

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Cancer
• Prostatic Hyperplasia

Intervention

Procedure:
• Digital Rectal Exam
The DRE digital rectal exam is an essential component of physical examination, but physicians enter their residency having neither been appropriately exposed nor trained in performing DREs. , the attending physician, resident physician(s), and medical student(s) will each perform a digital rectal exam on the subject, and independently document their examination on the DiRECT instrument.

Locations

Country	Name	City	State
United States	University of Virginia Health System, Dept of Urology	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate DiRECT tool		2 years