Decision Making in Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Decisional Conflict Scale (DCS) Score Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.
研究组 & 干预措施
MaPGAS Decision Aid Intervention
Participants in this arm will be provided with access to a novel, web-based decision aid designed for individuals considering MaPGAS. The decision aid includes interactive components, educational materials regarding surgical options, risks, benefits, and patient testimonials. Participants will have unlimited access to the decision aid for four weeks prior to their surgical consultation.
干预措施: MaPGAS Decision Aid (Behavioral)
MaPGAS Usual Care
Participants in this arm will receive the standard pre-consultation care provided by their healthcare provider, which does not include access to the novel decision aid. Standard care may include informational brochures. This group serves to compare the outcomes of traditional decision-making processes with those who use the decision aid.
结局指标
主要结局
Decisional Conflict Scale (DCS) Score Change
时间窗: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
The Decisional Conflict Scale (DCS) is used to measure personal perceptions of uncertainty in choosing options, factors contributing to uncertainty such as feeling uninformed, unclear about personal values, and unsupported in decision making, and perceived effectiveness of decision making. A change in DCS scores from baseline (pre-decision aid exposure) to post-decision aid exposure will be assessed to determine the impact of the decision aid on reducing decisional conflict. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].
Preparation for Decision Making (PrepDM) Scale Score Change
时间窗: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
The Preparation for Decision Making (PrepDM) scale assesses a patient's perception of how useful a health-related decision aid is in preparing them to make a health decision. It evaluates the perceived helpfulness of the decision aid in understanding treatment options, clarifying personal values for the decision, and feeling prepared to talk with their health provider about the decision. The change in PrepDM scores before and after decision aid exposure indicates the aid's efficacy in improving decision readiness. Higher scores indicate higher perceived level of preparation for decision making.
次要结局
- CollaboRATE Score Change Post-Surgical Consultation(Within one week following the surgical consultation.)
- System Usability Scale (SUS) Score(Immediately after using the decision aid (approximately 2-4 weeks from baseline))
研究者
Rachel A. Moses
Assistant Professor
Dartmouth-Hitchcock Medical Center