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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484665
• Other study ID #: 2011NTLS071
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: August 21, 2014
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Broadway Family Medicine Clinic	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provider Satisfaction with Implementation of the Shared Decision Making Process	Will be determined through a combination of surveys and responses to questions derived during focus groups.	At 3-5 Months	No
Primary	Provider Satisfaction with Implementation of the Shared Decision Making Process	Will be determined through a combination of surveys and responses to questions derived during focus groups.	At 8-10 Months	No
Secondary	Patient Satisfaction with Shared Decision Making and Reach of the Intervention	Will be determined through a questionnaire administered to patients.	At 8-10 Months	No
Secondary	Patient Satisfaction with Shared Decision Making and Reach of the Intervention	Will be determined through a questionnaire administered to patients.	At 3-5 Months	No