Digital Rectal Exam Proficiency Tool

NCT02278679 | Unknown DMC

• 1 other identifier: 17658
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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 .

Conditions

Prostatic Hyperplasia; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Validate DiRECT tool

  2 years

Study Arms (3)

Anesthitized patient

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.

Procedure: Digital Rectal Exam

Standardized patients

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.

Clinic patient

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.

Interventions

Digital Rectal Exam PROCEDURE

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.

Anesthitized patient

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with Benign Prostate Hypertrophy, Prostate Cancer or routine digital exam being seen by Urology Attendings, residents or medical students.

You may qualify if:

• 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

You may not qualify if:

• Patients who do not have a prostate
• Patients with previous pelvic/perineal surgery
• Previously enrolled in this study

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System, Dept of Urology

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Tracey L Krupski, M.D.

  University of Virginia, Dept of Urology

  PRINCIPAL INVESTIGATOR

• Raymond A Costabile, M.D.

  University of Virginia, Dept of Urology

  STUDY CHAIR

Central Study Contacts

Tracey L Krupski, M.D.

CONTACT

434-924-0042; tlk6t@virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Associate Professor of Urology

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

US (1)