Clinical trial NCT00630188: Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Official title: Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: prostate cancer screening
shared decision making
prostate-specific antigen
decision making
physician-patient relations
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: RTI International
First posted: 2008-03-06
Enrollment: 128
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Ages 40-80 years
* Their physician agreed to participate in the study
* Seen in practice for at least one year

Exclusion Criteria:

* 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

Primary outcomes:
measure: Men's understanding that prostate cancer screening requires a decision
timeFrame: baseline, post intervention, post clinical visit
measure: Men's knowledge about prostate cancer and prostate cancer screening
timeFrame: baseline, post intervention, post clinical visit
measure: Men's participation in the decision about prostate cancer screening with their clinician at their preferred level
timeFrame: baseline, post intervention, post clinical visit
Secondary outcomes:
measure: The presence of a shared decision
timeFrame: post clinical visit
measure: men's intent to be screened for prostate cancer
timeFrame: post clinical visit
measure: Self reported screening
timeFrame: post visit
measure: Actual screening by chart review
timeFrame: 9 month follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Chapel Hill North General Internal Medicine Practice
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill General Medicine Clinic
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Internal Medicine Practice
state: North Carolina
city: Greensboro
country: United States
facility: Triad Internal Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Russ Harris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Lauren McCormack, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: David Driscoll, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheridan SL, Golin C, Bunton A, Lykes JB, Schwartz B, McCormack L, Driscoll D, Bangdiwala SI, Harris RP. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials. BMC Med Inform Decis Mak. 2012 Nov 13;12:130. doi: 10.1186/1472-6947-12-130.