Decision Making in Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS) - Metoidioplasty and phalloplasty gender affirming surgeries (MaPGAS) are increasingly performed but remain high risk procedures that require patients to make complex decisions affecting future gender congruence, fertility, urinary, and sexual function. Prior studies demonstrate there is decisional uncertainty among transgender and non-binary individuals assigned female at birth considering MaPGAS which may lead to poor decision quality and outcomes. In these high-risk surgical decisions with multiple options with clinical equipoise, it is paramount to empower patients with decision support that facilitates quality decisions that are well informed, deliberated, and align with personal goals and values. However, there is a lack of validated MaPGAS decision support due to a historical lack of understanding of patients’ decisional needs and dearth of high-quality published outcomes or guidelines. Taken together, this limits the extent of MaPGAS counseling and shared decision making, potentially leading to poor quality decisions and unexpected outcomes. In our prior R21 we used a mixed methods design grounded in the Ottawa Decision Support Framework with community and provider stakeholders, to identify key themes surrounding patient surgical goals, values, and decision moderators from geographically diverse locations in the US. This was combined with a systematic review of the literature and modified Delphi consensus of high volume MaPGAS surgeons on patient focused surgical outcomes to create, iteratively revise, and sandpit test a community developed, web-based MaPGAS picture decision aid (DA) prototype. The DA provides information on the risks and outcomes associated with the most common MaPGAS options and a decision support tool applicable to patients of various health literacy levels already considering surgery. The purpose of this study is to 1) evaluate the usability and acceptability of the MaPGAS DA using a mixed methods approach including the validated System Usability Scale triangulated with key stakeholder focus groups feedback. Further, to 2) evaluate preliminary MaPGAS DA efficacy through a prospective randomized controlled trial at two geographically diverse institutions in patients already presenting for MaPGAS surgical consultation. This study will not provide funding for MaPGAS clinical or surgical care. The primary outcome includes change in pre and post DA decisional conflict (Decisional Conflict Scale) and decision readiness (Preparation for Decision Making Scale) as compared to usual care. The secondary outcome will include post-surgical consultation evaluation with the CollaboRATE measure coupled with semi structured patient and provider interviews on optimal DA administration timing, implementation, and impact on shared decision making. Successful completion of this study will refine the MaPGAS DA, test preliminary efficacy, and inform a larger prospective study designed to test broader acceptability, efficacy, and ultimately improve MaPGAS shared decision making.
