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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 10, 2012
Last Updated Date	January 24, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 24, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01516801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 24, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
Official Title ^ICMJE	A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
Brief Summary	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? 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening
Condition ^ICMJE	Prostate Cancer Screening
Intervention ^ICMJE	Other: PSA flyer A mailed low-literacy informational patient flyer about the PSA test
Study Arm (s)	Experimental: PSA flyer Intervention: Other: PSA flyer No Intervention: Control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	303
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	50 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01516801
Other Study ID Numbers ^ICMJE	10-0603
Has Data Monitoring Committee	No
Responsible Party	University of Colorado, Denver
Study Sponsor ^ICMJE	University of Colorado, Denver
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Colorado, Denver
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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