MaPGAS Decision Making

March 19, 2026 updated by: Rachel A. Moses, Dartmouth-Hitchcock Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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].
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within one week following the surgical consultation.
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.
Immediately after using the decision aid (approximately 2-4 weeks from baseline)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Post-decision aid use, and post-surgical consultation (dates vary, approximately 2-6 weeks from baseline).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
University of Utah
Dartmouth College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel A. Moses, MD, MPH, Dartmouth-Hitchcock Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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