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Digital Rectal Exam Proficiency Tool

Validation of the DiRECT Proficiency Tool

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02278679
Acronym
DiRECT
Enrollment
410
Registered
2014-10-30
Start date
2014-10-31
Completion date
2018-06-30
Last updated
2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Prostatic Hyperplasia

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.

Interventions

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.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
30 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Validate DiRECT tool2 years

Countries

United States

Contacts

Primary ContactTracey L Krupski, M.D.
tlk6t@virginia.edu434-924-0042

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026