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| Name | Class |
|---|---|
| RTI International | OTHER |
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The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.
Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates.
Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making |
|
| 2 | Active Comparator | Highway Safety video |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| You Decide | Other | For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making |
| Measure | Description | Time Frame |
|---|---|---|
| Men's understanding that prostate cancer screening requires a decision | baseline, post intervention, post clinical visit | |
| Men's knowledge about prostate cancer and prostate cancer screening | baseline, post intervention, post clinical visit | |
| Men's participation in the decision about prostate cancer screening with their clinician at their preferred level | baseline, post intervention, post clinical visit |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of a shared decision | post clinical visit | |
| men's intent to be screened for prostate cancer | post clinical visit | |
| Self reported screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russ Harris, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Lauren McCormack, PhD, MSPH | RTI International | Principal Investigator |
| David Driscoll, PhD, MSPH | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chapel Hill North General Internal Medicine Practice | Chapel Hill | North Carolina | 27516 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23148458 | Derived | Sheridan SL, Golin C, Bunton A, Lykes JB, Schwartz B, McCormack L, Driscoll D, Bangdiwala SI, Harris RP. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials. BMC Med Inform Decis Mak. 2012 Nov 13;12:130. doi: 10.1186/1472-6947-12-130. |
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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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| Reducing Your Risks in the Crash | Other | Publicly available video on highway safety and reducing individual risks in a crash |
|
| post visit |
| Actual screening by chart review | 9 month follow-up |
| University of North Carolina at Chapel Hill General Medicine Clinic |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Moses Cone Internal Medicine Practice | Greensboro | North Carolina | 27401 | United States |
| Triad Internal Medicine | Greensboro | North Carolina | 27405 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |