Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565663
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-19
Brief Title:
MaPGAS Decision Making
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Decision Making in Metoidioplasty and Phalloplasty Gender Affirming Surgery MaPGAS
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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 test a new online tool designed to provide clear and understandable information to help individuals considering Metoidioplasty and Phalloplasty Gender Affirming Surgery MaPGASmake informed decisions
The main questions it aims to answer are
How user-friendly is the decision aid for individuals considering metoidioplasty and phalloplasty
Does using the decision aid reduce uncertainty and improve readiness for making surgery decisions compared to usual care
Participants in this study will
Be randomly assigned to either 1 receive usual care or 2 test the web-based decision aid
Share their feedback on the tools usability and its helpfulness in supporting decision-making
Complete surveys before and after using the decision aid to measure any changes in their decision-making process
Researchers will compare participants who used the decision aid with those who received standard care to see if the decision aid reduces decisional uncertainty and improves readiness for surgery
The main questions it aims to answer are
How user-friendly is the decision aid for individuals considering metoidioplasty and phalloplasty
Does using the decision aid reduce uncertainty and improve readiness for making surgery decisions compared to usual care
Participants in this study will
Be randomly assigned to either 1 receive usual care or 2 test the web-based decision aid
Share their feedback on the tools usability and its helpfulness in supporting decision-making
Complete surveys before and after using the decision aid to measure any changes in their decision-making process
Researchers will compare participants who used the decision aid with those who received standard care to see if the decision aid reduces decisional uncertainty and improves readiness for surgery
Detailed Description:
This study aims to evaluate the usability acceptability and preliminary efficacy of a novel web-based decision aid DA for Metoidioplasty and Phalloplasty Gender Affirming Surgeries MaPGAS
MaPGAS are increasingly performed to improve gender congruence and quality of life however patients face complex decisions which may impact fertility urinary and sexual function Existing decisional uncertainty among transgender and non-binary individuals considering MaPGAS highlights the need for effective decision support tools Prior research indicates a gap in validated decision support partly due to insufficient understanding of patient needs and a lack of published outcomes or guidelines This study builds on preliminary work that identified key decision-making factors among patients and healthcare providers leading to the development of a co-developed web-based MaPGAS picture DA prototype
Cognitive interviews with both participants considering or post MaPGAS and healthcare providers will refine the decision tool The study will also investigate the DAs implementation within clinical settings to understand optimal administration timing and its impact on shared decision-making processes
This study will employ a mixed-methods approach and a prospective randomized controlled trial to assess the DAs usability and acceptability using the System Usability Scale and focus group feedback Additionally it aims to evaluate the DAs preliminary efficacy in reducing decisional conflict and improving decision readiness and shared decision-making quality compared to usual care This will be measured using validated tools such as the Decisional Conflict Scale Preparation for Decision Making Scale and CollaboRATE measure alongside semi-structured patient and provider interviews
This research aims to addressing the decisional needs of transgender and non-binary individuals considering MaPGAS aiming to empower them with the tools needed for making informed value-congruent decisions regarding their surgical options
MaPGAS are increasingly performed to improve gender congruence and quality of life however patients face complex decisions which may impact fertility urinary and sexual function Existing decisional uncertainty among transgender and non-binary individuals considering MaPGAS highlights the need for effective decision support tools Prior research indicates a gap in validated decision support partly due to insufficient understanding of patient needs and a lack of published outcomes or guidelines This study builds on preliminary work that identified key decision-making factors among patients and healthcare providers leading to the development of a co-developed web-based MaPGAS picture DA prototype
Cognitive interviews with both participants considering or post MaPGAS and healthcare providers will refine the decision tool The study will also investigate the DAs implementation within clinical settings to understand optimal administration timing and its impact on shared decision-making processes
This study will employ a mixed-methods approach and a prospective randomized controlled trial to assess the DAs usability and acceptability using the System Usability Scale and focus group feedback Additionally it aims to evaluate the DAs preliminary efficacy in reducing decisional conflict and improving decision readiness and shared decision-making quality compared to usual care This will be measured using validated tools such as the Decisional Conflict Scale Preparation for Decision Making Scale and CollaboRATE measure alongside semi-structured patient and provider interviews
This research aims to addressing the decisional needs of transgender and non-binary individuals considering MaPGAS aiming to empower them with the tools needed for making informed value-congruent decisions regarding their surgical options
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