Shared Decision Making: Prostate Cancer Screening

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00207649

Collaborator

(none)

641

Enrollment

Location

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: Shared decision-making for PSA screening tool	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

641 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Official Title:

Shared Decision Making: Prostate Cancer Screening

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Feb 1, 2011

Outcome Measures

Primary Outcome Measures

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) [study period]

Secondary Outcome Measures

1.Pre- and post-study changes in physician knowledge and attitudes about PSA [study period]
2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years [study period]
3.Patients post-visit knowledge and attitudes about PSA [study period]