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A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01516801
First received: January 10, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 10, 2012
January 24, 2012
October 2009
August 2010   (final data collection date for primary outcome measure)
  • Rate of PSA testing [ Time Frame: At the time of the annual exam (within two weeks of their annual physical) ] [ Designated as safety issue: No ]
    Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical
  • Rate of documented PSA discussions [ Time Frame: At the time of the annual exam (within two weeks of their annual physical) ] [ Designated as safety issue: No ]
    Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.
Same as current
Complete list of historical versions of study NCT01516801 on ClinicalTrials.gov Archive Site
  • Flyer acceptability [ Time Frame: Within two weeks of the annual exam ] [ Designated as safety issue: No ]
    The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.
  • Perceived participation [ Time Frame: Within two weeks ] [ Designated as safety issue: No ]
    Perceived participation will be assessed in a follow-up phone interview within two weeks of the annual physical using validated measures of particiption in decision making.
  • Prostate Cancer Screening knowledge [ Time Frame: Within two weeks ] [ Designated as safety issue: No ]
    Prostate cancer screening knowledge will be assessed using 5 knowledge questions surrounding PSA testing during a follow-up interview 2 weeks after the annual physical
Same as current
Not Provided
Not Provided
 
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
  1. Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?
  2. Do patients find the flyer useful and understandable?

Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Prostate Cancer Screening
Other: PSA flyer
A mailed low-literacy informational patient flyer about the PSA test
  • Experimental: PSA flyer
    Intervention: Other: PSA flyer
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men age 50-74 who were cared for in a general internal medicine clinic
  • had scheduled an annual health exam
  • had not had a PSA test within the previous year

Exclusion Criteria:

  • active cancer diagnosis
  • history of prostate cancer
  • need for PSA surveillance
Male
50 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516801
10-0603
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Not Provided
University of Colorado, Denver
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP