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The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMarkâ„¢ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Urologists will be randomly assigned to a control and intervention arm.
The Clinical Performance and Value Vignettes (CPV®) used in this study simulate a clinical encounter for a man presenting with prostate cancer. Each urologist will provide responses to open-ended questions regarding clinical care they would provide for that patient. These responses are scored in five domains (taking a medical history, performing a physical examination, ordering appropriate tests, making a diagnosis and prescribing treatment against explicit evidence and criteria as determined by the literature and medical associations. Results are presented as percentage correct. Each case will take approximately 15-20 minutes to complete. All case responses will be completed online and kept confidential.
The study hypotheses are:
The investigators will estimate the effect of ProMarkâ„¢ on the primary outcomes comparing treatment and control groups using a difference-in-difference analysis comparing differences between groups before and after intervention. The investigators will control for potential confounders, such as age, gender, and other physician and practice characteristics.
Secondary outcome measure include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProMark Information and Results | Experimental | Participants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection. |
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| Standard Practice | No Intervention | Physicians will care for online virtual patients as they normally would in practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProMark Information and Test Results | Other | Participants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined diagnostic and treatment CPV® (Clinical Performance and Value) vignette domain score | Difference in difference between the control and the intervention groups in the diagnosis-treatment quality of care as measured by their combined domain CPV scores (ranging from 0% to 100%) for the 9 patient types in aggregate and by case type. | 12 to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Peabody, MD PhD | QURE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QURE Healthcare | San Rafael | California | 94901 | United States |
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| Label | URL |
|---|---|
| Study Sponsor web page | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |