Shared Decision Making: Prostate Cancer Screening

NCT ID: NCT00207649

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 641 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-02-28

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 (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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

standard informational brochures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Web curriculum for physicians only

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.

Group Type: EXPERIMENTAL

Shared decision-making for PSA screening tool

Intervention Type: BEHAVIORAL

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. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.

Web curriculum for physicians and patients

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.

Group Type: EXPERIMENTAL

Shared decision-making for PSA screening tool

Intervention Type: BEHAVIORAL

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. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.

Interventions

Shared decision-making for PSA screening tool

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. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lisa Richarson

FED

Sponsor Role: lead

Responsible Party

Lisa Richarson

Associate Director for Science

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael S Wilkes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis, Center for Health Services Research

Sacramento, California, United States

Countries

United States

Other Identifiers

CDC-NCCDPHP-R-01-PH-000019

Identifier Type: -

Identifier Source: org_study_id