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Enrolling by Invitation

NCT Number: NCT06565663

MaPGAS Decision Making

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.

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Key information

Conditions

Gender Dysphoria Behavior Gender Dysphoria, Adult Gender Incongruence Mental Disorders Phalloplasty Sexual Behavior Sexual Dysfunctions, Psychological Sexuality Transgender Persons Transgenderism Transsexualism

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth College, Hanover, New Hampshire, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

MaPGAS Decision Aid

Behavioral

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.

Other names: Metoidioplasty and Phalloplasty Gender Affirming Surgery Web-Based Pictorial Decision Aid

Primary outcomes

  1. Decisional Conflict Scale (DCS) Score Change

    Time frame: 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].

  2. Preparation for Decision Making (PrepDM) Scale Score Change

    Time frame: 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.

Secondary outcomes

  1. CollaboRATE Score Change Post-Surgical Consultation

    Time frame: Within one week following the 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. Higher scores represent more shared decision making; scores can range from 0-100.

  2. System Usability Scale (SUS) Score

    Time frame: Immediately after using the decision aid (approximately 2-4 weeks from baseline)

    The System Usability Scale (SUS) Score 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. Higher scores represent a higher perceived system usability; scores can range from 0-100.

Other outcomes

  1. Qualitative Feedback from Cognitive Interviews

    Time frame: Post-decision aid use, and post-surgical consultation (dates vary, approximately 2-6 weeks from baseline).

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 22, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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