Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Men Age 50 Who Are Considering PSA Screening
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 2521
- Locations
- 2
- Primary Endpoint
- PSA test vs. No PSA test
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Carmen Lewis, MD, MPH
Associate Professor
University of North Carolina, Chapel Hill
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
PSA test vs. No PSA test
Time Frame: 12 month follow-up
We will determine whether a DESI viewing had an impact on testing.
Healthcare utilization and costs
Time Frame: 12 month follow-up
All prostate specific health care utilization and cost will be estimate for each group.
Secondary Outcomes
- Decision specific knowledge(4 months after mailings)
- Discussion with provider(4 months after mailings)
- DESI viewing(4 months after mailings)