Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Background: Professional societies recommend shared decision making for prostate cancer
screening, however, most effort has been directed at informed rather than shared decision
making. In this study, we plan to test the effects of a shared decision making intervention
on key components of shared decision making. We secondarily plan to test its effects on the
presence of a shared decision, men's intention to be screened, and actual screening rates.
Methods: We plan to conduct two separate randomized controlled trials of shared decision
making interventions, one in which the intervention focuses on prostate cancer screening
only and one in which the intervention focuses on prostate cancer screening in the context
of other men's health issues. Each trial will use the same attention control and identical
implementation and measurement strategies to allow combination of data if no differences
exist in the effect of the interventions. Trials will include a convenience sample of men
with no prior history of prostate cancer who present to their primary care physician for
routine care. Men will be randomly assigned to a shared decision making intervention
(including a video and coaching session for patients and an education session for providers)
or a control group, in which men will receive a video on highway safety. Data on key
components of shared decision making and intent for screening will be measured at baseline,
after the intervention, and after men's visit with their provider. Additionally, medical
charts will be reviewed 9 months later to assess for actual screening.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Men's understanding that prostate cancer screening requires a decision
baseline, post intervention, post clinical visit
No
Russ Harris, MD, MPH
Principal Investigator
University of North Carolina, Chapel Hill
United States: Institutional Review Board
TS-0845
NCT00630188
March 2005
April 2006
Name | Location |
---|---|
University of North Carolina at Chapel Hill General Medicine Clinic | Chapel Hill, North Carolina 27599 |
Chapel Hill North General Internal Medicine Practice | Chapel Hill, North Carolina 27516 |
Triad Internal Medicine | Greensboro, North Carolina 27405 |
Moses Cone Internal Medicine Practice | Greensboro, North Carolina 27401 |