Expired Study
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Sacramento, California 95817


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

CDC-NCCDPHP-R-01-PH-00001


NCT ID:

NCT00207649


Secondary ID:


Study Acronym:


Brief Title:

Shared Decision Making: Prostate Cancer Screening


Official Title:

Shared Decision Making: Prostate Cancer Screening


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Centers for Disease Control and Prevention


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Fact


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

641


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael S Wilkes, MD PhD
Principal Investigator
University of California, Davis

Study Dates

Start Date:November 2005
Completion Date:February 2011
Completion Type:Anticipated
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 23, 2011
First Received Date:September 14, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:3.Patients post-visit knowledge and attitudes about PSA
Time Frame:study period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years
Time Frame:study period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:1.Pre- and post-study changes in physician knowledge and attitudes about PSA
Time Frame:study period
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Shared decision-making for PSA screening tool
Description: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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Centers for Disease Control and Prevention

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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