Clinical trial NCT02278679: Digital Rectal Exam Proficiency Tool
Official title: Validation of the DiRECT Proficiency Tool
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Hyperplasia
Prostate Cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 410
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validate DiRECT tool
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System, Dept of Urology
state: Virginia
Study officials:
affiliation: University of Virginia, Dept of Urology
name: Tracey L Krupski, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia, Dept of Urology
name: Raymond A Costabile, M.D.
role: STUDY_CHAIR
References: