A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
Primary Purpose
Prostate Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PSA flyer
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer Screening focused on measuring Prostate Cancer Screening, Pragmatic Trial, Health Literacy
Eligibility Criteria
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
Sites / Locations
- University of Colorado Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PSA flyer
Control
Arm Description
Outcomes
Primary Outcome Measures
Rate of PSA testing
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
Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.
Secondary Outcome Measures
Flyer acceptability
The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.
Perceived participation
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
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
Full Information
NCT ID
NCT01516801
First Posted
January 10, 2012
Last Updated
January 24, 2012
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01516801
Brief Title
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
Official Title
A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Screening
Keywords
Prostate Cancer Screening, Pragmatic Trial, Health Literacy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSA flyer
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
PSA flyer
Intervention Description
A mailed low-literacy informational patient flyer about the PSA test
Primary Outcome Measure Information:
Title
Rate of PSA testing
Description
Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical
Time Frame
At the time of the annual exam (within two weeks of their annual physical)
Title
Rate of documented PSA discussions
Description
Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.
Time Frame
At the time of the annual exam (within two weeks of their annual physical)
Secondary Outcome Measure Information:
Title
Flyer acceptability
Description
The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.
Time Frame
Within two weeks of the annual exam
Title
Perceived participation
Description
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.
Time Frame
Within two weeks
Title
Prostate Cancer Screening knowledge
Description
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
Time Frame
Within two weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
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