Shared Decision Making: Prostate Cancer Screening

Prostate Cancer Clinical Trial

Official title:

Shared Decision Making: Prostate Cancer Screening

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00207649
• Other study ID #: CDC-NCCDPHP-R-01-PH-000019
• Status: Active, not recruiting
• Phase: N/A
• First received: September 14, 2005
• Last updated: March 23, 2011
• Start date: November 2005
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 641
• Est. completion date: February 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Davis, Center for Health Services Research	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	1.Pre- and post-study changes in physician knowledge and attitudes about PSA		study period	No
Secondary	2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years		study period	No
Secondary	3.Patients post-visit knowledge and attitudes about PSA		study period	No