Prostatic HyperplasiaDiRECTNCT02278679
Digital Rectal Exam Proficiency Tool
An observational study of Prostatic Hyperplasia and Prostate Cancer, run by University of Virginia at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 30 to 90 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Prostate Cancer
- What is being tested?
- Digital Rectal Exam
- Type of treatment
- Surgery or procedure
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- Men only
- No healthy volunteers
- 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.
Who may be able to join
- 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
Who cannot join
- List the criteria for exclusion
- Patients who do not have a prostate
- Patients with previous pelvic/perineal surgery
- Previously enrolled in this study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System, Dept of Urology
Charlottesville, Virginia, 22908
Tracey L Krupski, M.D., 434-924-0042, tlk6t@virginia.edu
Patricia Battle, LPN, CRC, 434-924-5649, pya@virginia.edu
About this study
Official title: Validation of the DiRECT Proficiency Tool
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 .
Read the 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
- Prostatic Hyperplasia, Prostate Cancer
- Being tested
- Digital Rectal Exam
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Rectal ExamProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Digital Rectal Exam | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate DiRECT tool
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey Krupski, MD, University of Virginia
- Investigators
- Tracey L Krupski, M.D., Principal investigator, University of Virginia, Dept of UrologyRaymond A Costabile, M.D., Study chair, University of Virginia, Dept of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278679
- Sponsor's protocol ID
- 17658
- Acronym
- DiRECT
- Status last verified
- May 2017
- First submitted
- 28 Oct 2014
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the DiRECT Proficiency Tool
- ClinicalTrials.gov ID
- NCT02278679
- Acronym / sponsor ID
- DiRECT / 17658
- Conditions
- Prostatic Hyperplasia, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anesthitized patient | – | Procedure: Digital Rectal ExamFirst, 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. |
| 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- List the criteria for exclusion
- Patients who do not have a prostate
- Patients with previous pelvic/perineal surgery
- Previously enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Rectal ExamThe 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. | Procedure or surgery | Anesthitized patient |
Primary outcome
Validate DiRECT tool
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey L Krupski, M.D. principal investigator
University of Virginia, Dept of Urology
Raymond A Costabile, M.D. study chair
University of Virginia, Dept of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia and Prostate Cancer, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracey L Krupski, M.D. (434-924-0042, tlk6t@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate DiRECT tool (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.