The goal of this clinical trial is to learn if the online, simulated human "Talk to Nathan About Prostate Cancer Screening" decision aid (https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html) is effective in helping patients decide about prostate cancer screening. The main questions it aims to answer are: * Is using the "Talk to Nathan About Prostate Cancer Screening" decision aid effective in improving knowledge, overcoming health literacy barriers, and resolving decisional conflict compared to a standard decision aid or standard education materials? * What are the barriers and best practices for incorporating Talk to Nathan About Prostate Cancer Screening into the flow of primary care practice? Researchers will compare "Talk to Nathan About Prostate Cancer Screening" to a standard decision aid and to standard prostate cancer screening education materials to test the effectiveness of using "Talk to Nathan About Prostate Cancer Screening." Participants will: * Use "Talk to Nathan About Prostate Cancer Screening," use a standard decision aid, or use standard education materials about prostate cancer screening * Visit the primary care clinic for follow-up * Complete surveys as part of the clinical trial
Goal of the project: To conduct a randomized controlled trial (RCT) to determine if CDC's online, simulated, human decision aid module, Talk to Nathan About Prostate Cancer Screening (treatment arm), is effective in improving knowledge, overcoming health literacy barriers, and resolving decisional conflict compared to a standard decision aid (control arm 1) and standard education materials (control arm 2). Also, to identify barriers and best practices for incorporating Talk to Nathan About Prostate Cancer Screening into the flow of primary care practice. Intended use of the resulting data: To measure evaluation outcomes, understand how to help men make decisions about the harms and benefits of prostate cancer screening that are in line with the patient's individual values and preferences, and make recommendations for improving the Talk to Nathan About Prostate Cancer Screening decision aid and incorporating it into primary care practice. Methods to be used to collect: The RCT is a three-group parallel design with one treatment arm and two control arms. Data will be collected from all arms using a pre-exposure survey, a post-exposure survey, and a post-clinic visit survey. The treatment arm will also complete a usability survey and a subset of the treatment arm will be invited to participate in user experience interviews. Health care providers at the four participating clinics will complete a short survey prior to executing the three-arm study and interviews will be conducted at the close of the study with study coordinators from the four participating clinics. The subpopulation to be studied: For the pre- and post-surveys, the usability survey, and the user experience interviews, the subpopulation is men aged 55-69 years. For the provider survey, the subpopulation is primary care providers who practice within the four clinics participating in the study. For the clinic coordinator interviews, the subpopulation is the study coordinators from the four participating clinics. How data will be analyzed: For quantitative survey data: intention-to-treat analysis; repeated measures analysis of variance across assessment time points; ordinary least squares regression; complier-average causal effect (CACE) approach to calculate treatment effect; maximum likelihood and Bayesian inferential methods for CACE. For qualitative data from the surveys and interviews: We will identify and analyze themes, patterns, and inter-relationships relevant to the evaluation questions for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
88
This decision aid is publicly available at this website in both English or Spanish: https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html
The standard decision aid is available here and will be used in either English or Spanish: https://massclearinghouse.ehs.state.ma.us/PROG-CANC/CA1382kit.html
The standard education materials are available from the National Cancer Institute (NCI) website in English or Spanish: https://www.cancer.gov/types/prostate/patient/prostate-screening-pdq
East Northport Medical Care
East Northport, New York, United States
Camino
Charlotte, North Carolina, United States
Alliance Medical Ministry
Raleigh, North Carolina, United States
Clemson Rural Health
Clemson, South Carolina, United States
Measure of changes in decisional conflict
Assessment by participant survey
Time frame: Immediately after clinical encounter with provider
Measure of prostate cancer knowledge
Assessment by participant survey
Time frame: Immediately after clinical encounter with provider
Measure of autonomous decision-making
Assessment by participant survey
Time frame: Immediately after clinical encounter with provider
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.