MaPGAS Decision Making

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gender Dysphoria; Transgender Persons; Transsexualism; Transgenderism; Gender Incongruence; Phalloplasty; Gender Dysphoria, Adult
• Intervention / Treatment: Behavioral: MaPGAS Decision Aid

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Hanover, New Hampshire, United States, 03755
      • Dartmouth College
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Metoidioplasty and Phalloplasty Gender Affirming Surgery Web-Based Pictorial Decision Aid
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Scores range from 0 [no decisional conflict] to 100 [extremely high 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 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.	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

Outcome Measure	Measure Description	Time Frame
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. Higher scores represent more shared decision making; scores can range from 0-100.	Within one week following the surgical consultation.
System Usability Scale (SUS) Score	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.	Immediately after using the decision aid (approximately 2-4 weeks from baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); University of Utah; Dartmouth College
• Investigators: Principal Investigator: Rachel A. Moses, MD, MPH, Dartmouth-Hitchcock Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): March 6, 2028

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Transgender; Gender Dysphoria; Gender-Affirming Surgery; Sex Reassignment Surgery; Gender Reassignment Surgery; Phalloplasty; Metoidioplasty; Transmasculine; FTM; Penile Reconstruction; Female-to-Male; Neophallus; Transsexual; Genital Reconstruction; Reconstructive Urology
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Behavior; Sexual Behavior; Sexuality; Gender Dysphoria; Transsexualism
• Other Study ID Numbers: STUDY02002174; 1R01DK137994-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study plans to share de-identified individual participant data (IPD) that underlie the results reported in publications, as well as the data dictionaries defining each field in the set. Sharing these datasets will enable secondary analyses by other researchers, promoting transparency and accelerating knowledge discovery in the field of gender affirming surgeries. The shared IPD will include demographic information, responses to surveys, and outcome measures such as the Decisional Conflict Scale, Preparation for Decision Making Scale, CollaboRATE measure, and other relevant data collected throughout the study.
• IPD Sharing Time Frame: The shared IPD and supporting documentation will become available starting 6 months after the publication of the main findings from the final dataset or two years from study completion, whichever comes first. The availability period for accessing these data will extend for five years, ensuring ample time for interested researchers to conduct secondary analyses.

IPD Sharing Access Criteria

Access to the shared IPD will be granted upon request to researchers who provide a methodologically sound proposal intended for non-commercial purposes. Requests will be reviewed by the study team. Criteria for reviewing requests will include the scientific rationale, methodological approach, and the potential contribution to understanding or improving gender affirming surgeries. Approved researchers will be required to sign a data access agreement to ensure the confidentiality and proper use of the data.

Information about how to request access to the IPD, including details of the review process and access criteria, will be made available on the study's dedicated webpage hosted by Dartmouth-Hitchcock Clinic's institutional repository, Dataverse.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No