Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610474
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Evaluation of an Online Prostate Cancer Screening Decision Aid
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of an Online Prostate Cancer Screening Decision Aid
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if the online simulated human Talk to Nathan About Prostate Cancer Screening decision aid httpswwwcdcgovprostate-cancertalk-to-nathanindexhtml 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
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
Detailed Description:
Goal of the project To conduct a randomized controlled trial RCT to determine if CDCs 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None