A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 303
- Locations
- 1
- Primary Endpoint
- Rate of PSA testing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 74 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PSA flyer
Intervention: PSA flyer (Other)
Control
Outcomes
Primary Outcomes
Rate of PSA testing
Time Frame: At the time of the annual exam (within two weeks of their annual physical)
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)
Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.
Secondary Outcomes
- Flyer acceptability(Within two weeks of the annual exam)
- Perceived participation(Within two weeks)
- Prostate Cancer Screening knowledge(Within two weeks)