Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT02278679

Conditions

Prostatic Hyperplasia

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Digital Rectal Exam

Study Details

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

Study ID

NCT02278679

Start date

Oct, 2014

Status verified date

May, 2017

Completion date

Jun, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

410 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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.

Primary outcome measure

  • Validate DiRECT tool [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tracey L Krupski, M.D.

434-924-0042tlk6t@virginia.edu

Locations

University of Virginia Health System, Dept of Urology

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Tracey L Krupski, M.D.

434-924-0042tlk6t@virginia.edu

Patricia Battle, LPN, CRC

434-924-5649pya@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 18, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2017-05-18.