Clinical trial NCT00207649: Shared Decision Making: Prostate Cancer Screening
Official title: Shared Decision Making: Prostate Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: shared decision-making
prostate cancer screening
evidence-based medicine
computer-assisted learning tools
standardized patients
randomized controlled trial
educational intervention
patient education
physician education
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-21
Enrollment: 641
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

Detailed description: 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

Primary outcomes:
measure: 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)
timeFrame: study period
Secondary outcomes:
measure: 1.Pre- and post-study changes in physician knowledge and attitudes about PSA
timeFrame: study period
measure: 2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years
timeFrame: study period
measure: 3.Patients post-visit knowledge and attitudes about PSA
timeFrame: study period
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis, Center for Health Services Research
state: California
Study officials:
affiliation: University of California, Davis
name: Michael S Wilkes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: