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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01484665
Enrollment
72
Registered
2011-12-02
Start date
2011-12-31
Completion date
2012-06-30
Last updated
2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

PSA screening, Decision aids

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.

Interventions

OTHERPROCASE 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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Provider Satisfaction with Implementation of the Shared Decision Making ProcessAt 3-5 MonthsWill be determined through a combination of surveys and responses to questions derived during focus groups.

Secondary

MeasureTime frameDescription
Patient Satisfaction with Shared Decision Making and Reach of the InterventionAt 8-10 MonthsWill be determined through a questionnaire administered to patients.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026