Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
- Conditions
- Prostatic Neoplasms
- Interventions
- Other: You DecideOther: Reducing Your Risks in the Crash
- Registration Number
- NCT00630188
- Lead Sponsor
- University of North Carolina
- Brief Summary
The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 128
- Ages 40-80 years
- Their physician agreed to participate in the study
- Seen in practice for at least one year
- Prior history of prostate cancer
- Presenting for acute medical visit
- Non-skin cancer
- Lung disease requiring oxygen
- Renal failure requiring dialysis
- Intensive care visit in last 6 months
- Need assistance with activities of daily living
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 You Decide For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making 2 Reducing Your Risks in the Crash Highway Safety video
- Primary Outcome Measures
Name Time Method Men's understanding that prostate cancer screening requires a decision baseline, post intervention, post clinical visit Men's knowledge about prostate cancer and prostate cancer screening baseline, post intervention, post clinical visit Men's participation in the decision about prostate cancer screening with their clinician at their preferred level baseline, post intervention, post clinical visit
- Secondary Outcome Measures
Name Time Method The presence of a shared decision post clinical visit men's intent to be screened for prostate cancer post clinical visit Self reported screening post visit Actual screening by chart review 9 month follow-up
Trial Locations
- Locations (4)
Triad Internal Medicine
🇺🇸Greensboro, North Carolina, United States
Chapel Hill North General Internal Medicine Practice
🇺🇸Chapel Hill, North Carolina, United States
Moses Cone Internal Medicine Practice
🇺🇸Greensboro, North Carolina, United States
University of North Carolina at Chapel Hill General Medicine Clinic
🇺🇸Chapel Hill, North Carolina, United States