## Protocol Section
### Identification Module
**NCT ID:** NCT02278679

**Acronym:** DiRECT

**Brief Title:** Digital Rectal Exam Proficiency Tool

**Official Title:** Validation of the DiRECT Proficiency Tool

#### Organization Study ID Info
**ID:** 17658
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2018-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-05-18

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-17

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-10

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2014-10-30
**Type:** ESTIMATED
**Study First Submit Date:** 2014-10-28
**Study First Submit QC Date:** 2014-10-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Virginia

#### Responsible Party

**Investigator Affiliation:** University of Virginia

**Investigator Full Name:** Tracey Krupski, MD

**Investigator Title:** M.D. Associate Professor of Urology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Prostatic Hyperplasia

- Prostate Cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 410

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Procedure: Digital Rectal Exam

**Label:** Anesthitized patient

#### Arm Group 2

**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:** Standardized patients

#### Arm Group 3

**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.

**Label:** Clinic patient

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Anesthitized patient

**Description:** 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.

**Name:** Digital Rectal Exam

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Validate DiRECT tool

**Time Frame:** 2 years

### Eligibility Module

**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

**Maximum Age:** 90 Years

**Minimum Age:** 30 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tlk6t@virginia.edu

**Name:** Tracey L Krupski, M.D.

**Phone:** 434-924-0042

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charlottesville

**Contacts:**

***Contact 1:***

- **Email:** tlk6t@virginia.edu

- **Name:** Tracey L Krupski, M.D.

- **Phone:** 434-924-0042

- **Role:** CONTACT

***Contact 2:***

- **Email:** pya@virginia.edu

- **Name:** Patricia Battle, LPN, CRC

- **Phone:** 434-924-5649

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Virginia Health System, Dept of Urology

**State:** Virginia

**Status:** RECRUITING

**Zip:** 22908

#### Overall Officials

**Official 1:**

**Affiliation:** University of Virginia, Dept of Urology

**Name:** Tracey L Krupski, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Virginia, Dept of Urology

**Name:** Raymond A Costabile, M.D.

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14334

- Name: Prostatic Hyperplasia

- Relevance: HIGH

- As Found: Prostatic Hyperplasia

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011470

- Term: Prostatic Hyperplasia

- ID: D000006965

- Term: Hyperplasia

### Misc Info Module

- Version Holder: 2024-05-24
