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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Screening Approved-not yet active 50 to 75 Other CDC-NCCDPHP-R-01-PH-000019 NCT00207649

Trial Description

Summary

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.

Further Study Information

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 Criteria

Inclusion Criteria:

• Physicians in primary care practice settings with male patients age 50-75

Exclusion Criteria:

• None

Trial Contact Information

Trial Lead Organizations/Sponsors

Centers for Disease Control

Michael S Wilkes, MD PhD

Principal Investigator

Julie Rainwater, PhD		Ph: 916-734-2827
		Email: jarainwater@ucdavis.edu

Jerilyn Higa, MS		Ph: 310-794-0526
		Email: JHiga@mednet.ucla.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00207649
Information obtained from ClinicalTrials.gov on October 20, 2008