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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: PROCASE Decision-Aid

• Registration Number: NCT01484665
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-30
• Study Start: 2011-12
• Study First Posted: 2011-12-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants (Males, age 50-75 yrs)	PROCASE Decision-Aid	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.

Primary Outcome Measures

Name	Time	Method
Provider Satisfaction with Implementation of the Shared Decision Making Process	At 8-10 Months	Will be determined through a combination of surveys and responses to questions derived during focus groups.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction with Shared Decision Making and Reach of the Intervention	At 3-5 Months	Will be determined through a questionnaire administered to patients.

Trial Locations

Locations (1)

Broadway Family Medicine Clinic; 🇺🇸 Minneapolis, Minnesota, United States