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Clinical Trials/NCT01484665
NCT01484665
Completed
N/A

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

University of Minnesota1 site in 1 country72 target enrollmentDecember 2011
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University of Minnesota
Enrollment
72
Locations
1
Primary Endpoint
Provider Satisfaction with Implementation of the Shared Decision Making Process
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
June 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Provider Satisfaction with Implementation of the Shared Decision Making Process

Time Frame: At 8-10 Months

Will be determined through a combination of surveys and responses to questions derived during focus groups.

Secondary Outcomes

  • Patient Satisfaction with Shared Decision Making and Reach of the Intervention(At 3-5 Months)

Study Sites (1)

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