PSA TOOL for Prostate Cancer Screening Discussions

Study Overview
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Brief Summary
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The study team created a tool to help identify patients who may benefit from shared decision making in the primary care setting. This tool is a guide to aid in decision making for prostate cancer screening. The team proposes the topics to be discussed in the screening conversation include the risk for developing prostate cancer based upon age, race/ethnicity, family history of prostate cancer, history of previous digital rectal exam, and history of previous prostate specific antigen (PSA) as well as self-reported health status and preferences for treatment. The team now proposes 1) testing this tool first for ease of use in primary care clinics 2) revising this tool based upon feedback from patients and providers, then 3) testing this tool for effectiveness in improving patient knowledge that they have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision.

Detailed Description
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Objectives: To pilot test a decision making tool, the PSA TOOL, for prostate cancer screening for usefulness and ease of use in primary care practices. To revise the PSA TOOL based upon provider and patient feedback. To assess patient knowledge about the option to be screened for prostate cancer and factors to consider in the prostate cancer screening decision before and after use of the tool. Study Design: This protocol is for field testing of a brief tool to improve prostate cancer screening discussions that occur at previously scheduled primary care outpatient visits.

Official Title
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Testing of a Brief Tool (PSA TOOL) for Prostate Cancer Screening Discussions in Primary Care Settings

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: PSA TOOL
* Behavioral: Revised PSA TOOL
* Behavioral: Informal Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provider: Provider at selected primary care practices in the Cleveland Clinic Health System Willing to utilize a guide to aid in decision making for prostate cancer screening Patient: - Patient of participating Cleveland Clinic primary care provider who is scheduled for a routine appointment with the provider Exclusion Criteria: Not a patient or provider of the Cleveland Clinic Health System

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Initially, health care providers will give feedback on the tool. The tool will be revised and the second segment of the study will be to give the revised tool to patients with pre- and post-tests which measure changes in prostate cancer screening knowledge.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provider Field Test<br>15 providers will be given an initial version of the PSA TOOL, over a 4 week period, they will be able to provide feedback on the tool. This will be used to revise the screening decision aid. Informal interviews with providers will also be conducted by a member of the study team to obtain feedback about ease of use and usefulness of the tool. | Behavioral: PSA TOOL<br>* Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.<br>Behavioral: Informal Interview<br>* Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.<br>|
| Experimental: Patient test of revised PSA TOOL<br>150 patients will be asked to use the revised PSA TOOL. Pre- and Post-tests will be given to see if the tool changed the knowledge that patients have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision. Informal interviews with patients who are exposed to the tool will also be conducted by a member of the study team to obtain feedback on issues addressed by the survey questions. | Behavioral: Revised PSA TOOL<br>* Patients will be given the revised PSA TOOL, after providers have given their initial feedback.<br>Behavioral: Informal Interview<br>* Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score from Perceived Usefulness scale | scale will be summarized as means and standard deviations | Up to 4 weeks after getting PSA TOOL | 
| Score from Perceived Ease of Use scale | scale will be summarized as means and standard deviations | Up to 4 weeks after getting PSA TOOL | 
| Change in Score from Pre-Test to Post-Test | The paired t-test will be used to compare the pre- and post- patient survey scores | Up to 30 minutes after Pre-Test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Shared Decision Making