NCT00207649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
641

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

4.3 years

First QC Date

September 14, 2005

Last Update Submit

October 3, 2024

Conditions

Prostate Cancer

Keywords

shared decision-makingprostate cancer screeningevidence-based medicinecomputer-assisted learning toolsstandardized patientsrandomized controlled trialeducational interventionpatient educationphysician education

Outcome Measures

Primary Outcomes (1)

  • Intervention groups (physician education only, both physician and patient education) vs. control group comparison of physician shared decision-making (SDM) behaviors (self-reported SDM and SDM reported by actual and standardized patients)

    study period

Secondary Outcomes (3)

  • 1.Pre- and post-study changes in physician knowledge and attitudes about PSA

    study period

  • 2.Pre- and post-study changes in physicians' PSA ordering behavior for their patients age 50-75 years

    study period

  • 3.Patients post-visit knowledge and attitudes about PSA

    study period

Study Arms (3)

Control group

NO INTERVENTION

standard informational brochures

Web curriculum for physicians only

EXPERIMENTAL

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.

Behavioral: Shared decision-making for PSA screening tool

Web curriculum for physicians and patients

EXPERIMENTAL

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.

Behavioral: Shared decision-making for PSA screening tool

Interventions

Shared decision-making for PSA screening toolBEHAVIORAL

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 patientsWeb curriculum for physicians only

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis, Center for Health Services Research

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michael S Wilkes, MD PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Director for Science

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

November 1, 2005

Primary Completion

March 1, 2010

Study Completion

February 1, 2011

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations

US(1)