MaPGAS Decision Making
Decision Making in Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS)
2 other identifiers
interventional
140
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Start
First participant enrolled
October 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 6, 2028
March 23, 2026
November 1, 2025
3.3 years
June 19, 2024
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
CollaboRATE Score Change Post-Surgical Consultation
Within one week following the surgical consultation.
System Usability Scale (SUS) Score
Immediately after using the decision aid (approximately 2-4 weeks from baseline)
Other Outcomes (1)
Qualitative Feedback from Cognitive Interviews
Post-decision aid use, and post-surgical consultation (dates vary, approximately 2-6 weeks from baseline).
Study Arms (2)
MaPGAS Decision Aid Intervention
EXPERIMENTALParticipants 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.
MaPGAS Usual Care
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institutes of Health (NIH)collaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Dartmouth-Hitchcock Medical Centerlead
- University of Utahcollaborator
- Dartmouth Collegecollaborator
Study Sites (2)
Dartmouth College
Hanover, New Hampshire, 03755, United States
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel A. Moses, MD, MPH
Dartmouth-Hitchcock Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 19, 2024
First Posted
August 22, 2024
Study Start
October 23, 2024
Primary Completion (Estimated)
February 2, 2028
Study Completion (Estimated)
March 6, 2028
Last Updated
March 23, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.