Shared Decision Making: Prostate Cancer Screening

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Centers for Disease Control and Prevention.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207649
First received: September 14, 2005
Last updated: March 23, 2011
Last verified: March 2011

September 14, 2005
March 23, 2011
November 2005
March 2010   (final data collection date for primary outcome 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) [ Time Frame: study period ] [ Designated as safety issue: No ]
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)
Complete list of historical versions of study NCT00207649 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1.Pre- and post-study changes in physician knowledge and attitudes about PSA
  • 2.Pre- and post-study changes in physicians’ PSA ordering behavior for their patients age 50-75 years
  • 3.Patients post-visit knowledge and attitudes about PSA
Not Provided
Not Provided
 
Shared Decision Making: Prostate Cancer Screening
Shared Decision Making: Prostate Cancer Screening

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Prostate Cancer
Behavioral: Shared decision-making for PSA screening tool
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. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
641
February 2011
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00207649
CDC-NCCDPHP-R-01-PH-000019
No
Julie Rainwater, PhD, University of California Davis School of Medicine
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Michael S Wilkes, MD PhD University of California, Davis
Centers for Disease Control and Prevention
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP