Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men

Study Overview
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Brief Summary
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This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.

Detailed Description
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The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of PSA-based screening. As characterized by the USPSTF, these conversations are particularly important for African American men given increased ambiguity due to the lack of PSA-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in African American men. The goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of an educational intervention for African American males to increase shared decision making about PSA-screening versus usual care. The intervention will use multimedia educational training materials to increase understanding of prostate cancer, PSA-based screening, and shared decision making among patients and their primary care providers (PCPs).

Official Title
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Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Educational Shared Decision-Making Intervention


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: Receiving care at the clinical sites Identify as African American male Ages 40-69 years old Patient Exclusion Criteria: Personal history of prostate cancer at the time of consent Cognitive impairment that would interfere with participation in the study Unable to complete any aspect of the intervention within the specified time limit

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients in the intervention will receive the educational intervention | Behavioral: Educational Shared Decision-Making Intervention<br>* The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.<br>|
| No Intervention: Usual Care<br>Patients in the control arm will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared decision-making | Patient-provider visits will be audio-recorded and coded for the extent of shared decision making about prostate cancer using a defined scheme. The Observing Patient Involvement (OPTION) Scale will be used for the coding. Total OPTION scale ranges from 0 to 48. Higher values mean higher patient involvement during the shared decision making process. | One month after audio-recorded visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Decision (QD) | A percentage score of the following four subscales. The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made. Prostate Cancer Screening Knowledge (20 items): Total score ranges from 0 to 20. Higher values mean higher knowledge of prostate cancer screening. Decision Confidence (10 items): Total score ranges from 0 to 40. Higher values mean higher confidence in the decision made. Decisional Self-efficacy questionnaire (4 items): Total score ranges from 4 to 20. Higher values mean higher efficacy in the communication used during the shared decision encounter. Satisfaction with Decision (6 items): Total score ranges from 6 to 30. Higher values mean higher satisfaction with the decision made. | Up to one 24 weeks after the audio-recorded visit | 
| Preference-Congruent Decision Making | The Intention-to-Screen score ranges from 0 to 1. Score = 0 means no intention to receive the PSA test while score = 1 means intention to receive the PSA. Preference-concordant decision making will be scored as 1 (POSITIVE) for those patients with Intention-to-Screen value = 1 who actually receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did not receive it. Preference-concordant decision making will be scored as 0 (NEGATIVE) for those patients with Intention-to-Screen value = 1 who did not receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did receive it. A congruence score of 1 means congruence between patient intention and real action, while a congruence score of 0 means patient in-congruence between intention and real action. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Primary Care, PSA-screening, African American males