Healthy Men Age 50 Who Are Considering PSA Screening
Conditions
Keywords
Prostate cancer, Decision support intervention (DESI), Shared medical appointments (SMA), Comparative effectiveness research (CER)
Brief summary
In this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (DESI) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design. We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.
Detailed description
We will use a randomized experimental design to compare the effects of 3 different strategies to implement a prostate cancer screening decision support intervention (DESI) with a control condition in primary care in 2 clinical systems - PAMF (Palo Alto Medical Foundation) and UNC. The primary outcomes of interest are men's screening decisions and their subsequent healthcare utilization. Secondary outcomes include the likelihood that they review the DESI and their decision-specific knowledge. The 3 strategies selected by the PAMF and UNC health systems are: (1) mailing men a DESI in DVD; (2) inviting men to participate in a shared (group) medical appointment (SMA) to watch and discuss the DESI with a healthcare provider and other men; and (3) providing men options by inviting them to a SMA while also providing them a DESI in DVD which they can use individually if they are unable or choose not to attend a SMA. The 3 groups will be compared to a control condition that does not receive a DESI but will be encouraged to discuss prostate cancer screening with their physician. Because of its significantly larger patient population, the PAMF site will also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday, when they first become guideline eligible to consider prostate cancer screening.
Interventions
BEHAVIORALDESI for home viewing
Decision support intervention is a 31 minute DVD mailed to the patients in all of the experimental groups. The program explains the function and location of the prostate and the nature of prostate cancer, including its associated mortality. Next, the program describes the different tests that are used to detect prostate cancer including the digital rectal exam, prostate specific antigen (PSA) test and prostate biopsy.
BEHAVIORALDESI for viewing at Shared Medical Appointment
Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
BEHAVIORALOption of SMA and DESI or DESI only
Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
Sponsors
Palo Alto Medical Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* age 50 or older * do not have a prostate diagnosis * have not had a PSA test in the past 10 months * have not seen their primary care physicians in the last 3 months
Exclusion criteria
* Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA test vs. No PSA test | 12 month follow-up | We will determine whether a DESI viewing had an impact on testing. |
| Healthcare utilization and costs | 12 month follow-up | All prostate specific health care utilization and cost will be estimate for each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DESI viewing | 4 months after mailings | Did the patient view the decision support intervention or not? |
| Decision specific knowledge | 4 months after mailings | Patient's knowledge will be assessed with a validated 10-item measure. |
| Discussion with provider | 4 months after mailings | Patients will be asked if they discussed prostate cancer screening with a healthcare provider. |
Countries
United States
Outcome results
None listed