Clinical trial · Observational
Digital Rectal Exam Proficiency Tool
Validation of the DiRECT Proficiency Tool
NCT02278679CI-TRIAL-00027669DiRECTunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Rectal Exam | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Anesthitized patient
- 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.
- interventionNames
- Procedure: Digital Rectal Exam
- label
- Standardized patients
- description
- 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.
- label
- Clinic patient
- description
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.