MaPGAS Decision Making
NCT Number: NCT06565663
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gender Dysphoria|Gender Dysphoria, Adult|Gender Incongruence|Transgenderism|Transsexualism|Transgender Persons|Phalloplasty
Interventions: BEHAVIORAL: MaPGAS Decision Aid
Sponsor: Dartmouth-Hitchcock Medical Center
Collaborators: University of Utah|Dartmouth College|National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2027-02
Locations: Dartmouth College, Hanover, New Hampshire, 03755, United States|University of Utah, Salt Lake City, Utah, 84112, United States

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 (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.

Primary Outcome Measures: Decisional Conflict Scale (DCS) Score Change, 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., 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, The 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., Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
Secondary Outcome Measures: CollaboRATE Score Change Post-Surgical Consultation, The CollaboRATE score is a brief patient-reported measure assessing the extent of shared decision-making experienced during medical encounters. It focuses on three core aspects: the explanation of health issues, the elicitation of patient preferences, and the integration of these preferences into the decision-making process. A comparison of CollaboRATE scores between control and intervention groups after the surgical consultation will indicate the decision aid's impact on enhancing shared decision making., Within one week following the surgical consultation.|System Usability Scale (SUS) Score, The SUS is a reliable tool for measuring the usability of the web-based decision aid. It consists of a 10-item questionnaire with five response options for respondents ranging from 'Strongly agree' to 'Strongly disagree'. It is widely used in the domain of user experience and measures the overall perceived usability of the decision aid., Immediately after using the decision aid (approximately 2-4 weeks from baseline)
Other Outcome Measures: Qualitative Feedback from Cognitive Interviews, Qualitative feedback will be obtained through cognitive interviews with participants to refine the decision tool. This feedback will include participants' experiences using the tool, its clarity, relevance, and any suggestions for improvement. The interviews aim to capture in-depth insights into the decision aid's effectiveness and areas for enhancement., Post-decision aid use, and post-surgical consultation (dates vary, approximately 2-6 weeks from baseline).