Shared Decision Making: Prostate Cancer Screening
Recruitment status was Active, not recruiting
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Purpose
Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve the interaction of physicians and their patients about prostate cancer screening. Educational material is provided in primary care practices using either standard paper information or a novel web-based interactive curriculum that explores the risks and benefits of screening measures for prostate cancer for older men. The impact of the intervention on shared decision-making with both actual and standardized patients will be assessed.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Behavioral: Shared decision-making for PSA screening tool |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label |
| Official Title: | Shared Decision Making: Prostate Cancer Screening |
- Intervention groups (physician education only, both physician and patient education) vs. control group comparison of physician shared decision-making (SDM) behaviors (self-reported SDM and SDM reported by actual and standardized patients) [ Time Frame: study period ] [ Designated as safety issue: No ]
- 1.Pre- and post-study changes in physician knowledge and attitudes about PSA [ Time Frame: study period ] [ Designated as safety issue: No ]
- 2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years [ Time Frame: study period ] [ Designated as safety issue: No ]
- 3.Patients post-visit knowledge and attitudes about PSA [ Time Frame: study period ] [ Designated as safety issue: No ]
| Enrollment: | 641 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | February 2011 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
-
Behavioral: Shared decision-making for PSA screening tool
Prostate cancer is an important cause of death and disability in US men, but the value of screening for the disease with the prostate specific antigen (PSA) test remains highly controversial. Many primary care physicians use PSA testing routinely, with little patient counseling. Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. Physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. In addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. The intervention will be evaluated among 140 physicians within a variety of primary care settings (i.e., University-based clinics, staff-model managed care clinics, and military affiliated outpatient clinics). Approximately 10-15 actual patients of each participating physician will complete a post-visit questionnaire describing their discussion with their doctor about prostate cancer, PSA, and their decision about whether to be screened. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA. Study groups will be compared on the extent of shared decision-making they engage in with both actual and standardized patients. Pre- and post-study changes in physician knowledge and attitudes about PSA as well as the physicians' pre- and post-study PSA test ordering rates will be ascertained.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Physicians in primary care practice settings with male patients age 50-75
Exclusion Criteria:
- None
Contacts and Locations| United States, California | |
| University of California Davis, Center for Health Services Research | |
| Sacramento, California, United States, 95817 | |
| Principal Investigator: | Michael S Wilkes, MD PhD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | Julie Rainwater, PhD, University of California Davis School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00207649 History of Changes |
| Other Study ID Numbers: | CDC-NCCDPHP-R-01-PH-000019 |
| Study First Received: | September 14, 2005 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
shared decision-making prostate cancer screening evidence-based medicine computer-assisted learning tools standardized patients |
randomized controlled trial educational intervention patient education physician education |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013