Digital Rectal Exam Proficiency Tool

• Conditions: Prostatic Hyperplasia; Prostate Cancer
• Interventions: Procedure: Digital Rectal Exam

• Registration Number: NCT02278679
• Lead Sponsor: University of Virginia

Brief 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 .

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-18
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 410

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anesthitized patient	Digital Rectal Exam	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.

Primary Outcome Measures

Name	Time	Method
Validate DiRECT tool	2 years

Trial Locations

Locations (1)

University of Virginia Health System, Dept of Urology; 🇺🇸 Charlottesville, Virginia, United States