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Digital Rectal Exam Proficiency Tool (DiRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278679
Recruitment Status : Unknown
Verified May 2017 by Tracey Krupski, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : October 30, 2014
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Tracey Krupski, MD, University of Virginia

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 .

Condition or disease Intervention/treatment
Prostatic Hyperplasia Prostate Cancer Procedure: Digital Rectal Exam

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.

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Study Type : Observational
Estimated Enrollment : 410 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the DiRECT Proficiency Tool
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: 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.

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.



Primary Outcome Measures :
  1. Validate DiRECT tool [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278679


Contacts
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Contact: Tracey L Krupski, M.D. 434-924-0042 tlk6t@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System, Dept of Urology Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Tracey L Krupski, M.D.    434-924-0042    tlk6t@virginia.edu   
Contact: Patricia Battle, LPN, CRC    434-924-5649    pya@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Tracey L Krupski, M.D. University of Virginia, Dept of Urology
Study Chair: Raymond A Costabile, M.D. University of Virginia, Dept of Urology

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Responsible Party: Tracey Krupski, MD, M.D. Associate Professor of Urology, University of Virginia
ClinicalTrials.gov Identifier: NCT02278679    
Other Study ID Numbers: 17658
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes