Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1
NCT01241656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2521
Last updated 2013-06-25
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.
Conditions
- Healthy Men Age 50 Who Are Considering PSA Screening
Interventions
- BEHAVIORAL
-
DESI 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.
- BEHAVIORAL
-
DESI 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.
- BEHAVIORAL
-
Option 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 & Collaborators
-
Palo Alto Medical Foundation
collaborator OTHER -
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Carmen L Lewis, MD, MPH · University of North Carolina, Chapel Hill
-
Ming Tai-Seale, Ph.D, MPH · Palo Alto Medical Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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