Shared Decision Making: Prostate Cancer Screening

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Centers for Disease Control and Prevention.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207649
First received: September 14, 2005
Last updated: March 23, 2011
Last verified: March 2011
  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: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
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) [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1.Pre- and post-study changes in physician knowledge and attitudes about PSA [ Time Frame: study period ] [ Designated as safety issue: No ]
  • 2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years [ Time Frame: study period ] [ Designated as safety issue: No ]
  • 3.Patients post-visit knowledge and attitudes about PSA [ Time Frame: study period ] [ Designated as safety issue: No ]

Enrollment: 641
Study Start Date: November 2005
Estimated Study Completion Date: February 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207649

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

Responsible Party: Julie Rainwater, PhD, University of California Davis School of Medicine
ClinicalTrials.gov Identifier: NCT00207649     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-R-01-PH-000019
Study First Received: September 14, 2005
Last Updated: March 23, 2011
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

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

ClinicalTrials.gov processed this record on August 28, 2014