MaPGAS Decision Making

Официальное название

Decision Making in Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS)

Обзор

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 (MaPGAS)make 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 tool's 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.

Подробное описание

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 DA's 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 DA's usability and acceptability using the System Usability Scale and focus group feedback. Additionally, it aims to evaluate the DA's 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.

Вмешательства

• Поведенческое MaPGAS Decision Aid
  This intervention involves a novel, web-based decision aid tool specifically designed to support transgender and non-binary individuals assigned female at birth in making informed decisions about Metoidioplasty and Phalloplasty Gender Affirming Surgeries (MaPGAS). The tool includes comprehensive information on surgical options, risks, benefits, and medical illustrations to aid in aligning surgical decisions with the individual's personal values and goals.

Первичные конечные точки

• Decisional Conflict Scale (DCS) Score Change [Срок оценки: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).]
• Preparation for Decision Making (PrepDM) Scale Score Change [Срок оценки: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).]

Вторичные конечные точки (2)

• CollaboRATE Score Change Post-Surgical Consultation [Срок оценки: Within one week following the surgical consultation.]
• System Usability Scale (SUS) Score [Срок оценки: Immediately after using the decision aid (approximately 2-4 weeks from baseline)]

Критерии участия

Критерии включения

• Assigned female on the original birth certificate.
• Self-identifies as transgender male and/or gender non-binary.
• Able to speak, read, and understand English at a sixth-grade level.
• Aged 18 or older.
• Resides in the USA.
• For decision aid refinement: Considering metoidioplasty or phalloplasty, or is post-operative.
• For intervention and control arm: Has a consultation scheduled for metoidioplasty or phalloplasty.

Критерии исключения

• Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 2 центра

• Dartmouth College — Hanover
• University of Utah — Salt Lake City

Идентификаторы

NCT: NCT06565663 · STUDY02002174 · 1R01DK137994-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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