Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment shared decision-making for psa screening tool
Sponsor Centers for Disease Control and Prevention
Start date November 2005
End date March 2010
Trial size 641 participants
Trial identifier NCT00207649, CDC-NCCDPHP-R-01-PH-000019

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label

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)
time frame: study period

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Physicians in primary care practice settings with male patients age 50-75 Exclusion Criteria: - None

Additional Information

Official title Shared Decision Making: Prostate Cancer Screening
Principal investigator Michael S Wilkes, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Centers for Disease Control and Prevention.