Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

NCT ID: NCT01484665

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-06-30

Brief Summary

Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.

Detailed Description

This pilot project will evaluate two approaches to implementing the use of a simple printed PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a significant number of African-Americans. All subjects will complete a survey assessing their knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians will also be briefly queried about their perceptions of the SDM process.

After the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of DA in the clinical setting. Another three month implementation period will follow using the same methods to assess outcomes. Finally we will conduct another round of focus groups to assess the overall impact of the interventions.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Participants (Males, age 50-75 yrs)

Eligible men will be identified from the administrative database and electronic medical record at the University of Minnesota (EMR) at least 24 hours prior to the clinic visit. They will be asked to complete the PROCASE Decision-Aid.

Group Type: EXPERIMENTAL

PROCASE Decision-Aid

Intervention Type: OTHER

VA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled "The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study.

Interventions

PROCASE Decision-Aid

VA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled "The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males ages 50-75
• Able to read and speak English
• Provide written informed consent

Exclusion Criteria

• Diagnosis of prostate cancer
• PSA testing within last 12 months
• Previous prostate biopsy
• Voiding problems as reason for clinic visit
• Visit scheduled same day or 'walk-In' patient

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Warlick, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Broadway Family Medicine Clinic

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2011NTLS071

Identifier Type: -

Identifier Source: org_study_id