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Shared Decision Making: Prostate Cancer Screening

L

Lisa Richarson

Status

Completed

Conditions

Prostate Cancer

Treatments

Behavioral: Shared decision-making for PSA screening tool

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00207649
CDC-NCCDPHP-R-01-PH-000019

Details and patient eligibility

About

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.

Full 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 (i.e., 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.

Enrollment

641 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Physicians in primary care practice settings with male patients age 50-75

Exclusion criteria

  • None

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

641 participants in 3 patient groups

Control group
No Intervention group
Description:
standard informational brochures
Web curriculum for physicians only
Experimental group
Description:
Both intervention arms will use 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 one of the intervention arms, the physicians saw the web-based interactive curriculum and the patient received the brochure.
Treatment:
Behavioral: Shared decision-making for PSA screening tool
Web curriculum for physicians and patients
Experimental group
Description:
In the other intervention arm, the physicians saw the web-based curriculum and the patient received interactive curriculum covering content similar to that contained in the web-based interactive curriculum for physicians.
Treatment:
Behavioral: Shared decision-making for PSA screening tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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