Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207649
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2005-09-14
Brief Title:
Shared Decision Making Prostate Cancer Screening
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Shared Decision Making Prostate Cancer Screening
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interventions to Improve Shared Decision-Making Prostate Cancer Screening is a prospective study of educational interventions to improve the interaction of physicians and their patients about prostate cancer screening Educational material is provided in primary care practices using either standard paper information or a novel web-based interactive curriculum that explores the risks and benefits of screening measures for prostate cancer for older men The impact of the intervention on shared decision-making with both actual and standardized patients will be assessed
Detailed Description:
Prostate cancer is an important cause of death and disability in US men but the value of screening for the disease with the prostate specific antigen PSA test remains highly controversial Many primary care physicians use PSA testing routinely with little patient counseling Interventions to Improve Shared Decision-Making Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening Physicians will be randomized by practice site to receive standard informational brochures control group or a novel web-based interactive curriculum that provides education about prostate cancer screening including potential benefits and harms fundamentals of effective patient counsel and shared decision-making In addition patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool The intervention will be evaluated among 140 physicians within a variety of primary care settings ie University-based clinics staff-model managed care clinics and military affiliated outpatient clinics Approximately 10-15 actual patients of each participating physician will complete a post-visit questionnaire describing their discussion with their doctor about prostate cancer PSA and their decision about whether to be screened Physicians in all groups will also see one unannounced standardized patient SP trained to portray a patient interested in discussing PSA Study groups will be compared on the extent of shared decision-making they engage in with both actual and standardized patients Pre- and post-study changes in physician knowledge and attitudes about PSA as well as the physicians pre- and post-study PSA test ordering rates will be ascertained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None