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Shared Decision Making: Prostate Cancer Screening
This study is not yet open for participant recruitment.
Verified by Centers for Disease Control and Prevention, September 2005
First Received: September 14, 2005   No Changes Posted
Sponsored by: Centers for Disease Control and Prevention
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00207649
  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.


Condition Intervention
Prostate Cancer
Behavioral: Shared decision-making for PSA screening tool

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Factorial Assignment
Official Title: Shared Decision Making: Prostate Cancer Screening

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 140
Study Start Date: November 2005
Estimated Study Completion Date: February 2008
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207649

Contacts
Contact: Julie Rainwater, PhD 916-734-2827 jarainwater@ucdavis.edu
Contact: Jerilyn Higa, MS 310-794-0526 JHiga@mednet.ucla.edu

Locations
United States, California
University of California Davis, Center for Health Services Research
Sacramento, California, United States, 95817
Sponsors and Collaborators
Investigators
Principal Investigator: Michael S Wilkes, MD PhD University of California, Davis
  More Information

No publications provided

Study ID Numbers: CDC-NCCDPHP-R-01-PH-000019
Study First Received: September 14, 2005
Last Updated: September 14, 2005
ClinicalTrials.gov Identifier: NCT00207649     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
shared decision-making
prostate cancer screening
evidence-based medicine
computer-assisted learning tools
standardized patients
randomized controlled trial
educational intervention
patient education
physician education

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009