Decision Aid for Gender Dysphoria

Recruiting at 1 trial location

Overseen By Lee K Brown

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Focus group participants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MaPGAS Decision Aid treatment for gender dysphoria?

Research on decision aids for hormone replacement therapy (HRT) shows that they help people make more informed and confident decisions by improving their understanding of treatment benefits and risks. This suggests that the MaPGAS Decision Aid could similarly support individuals with gender dysphoria in making informed treatment decisions. ^{1 2 3 4 5}

How does the Decision Aid for Gender Dysphoria treatment differ from other treatments for gender dysphoria?

The Decision Aid for Gender Dysphoria treatment is unique because it focuses on providing a structured decision-making tool to help individuals with gender dysphoria understand their options and make informed choices about their care, rather than directly offering medical or hormonal interventions. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Rachel A. Moses, MD, MPH

Principal Investigator

Dartmouth-Hitchcock Clinic

Eligibility Criteria

This trial is for transgender individuals considering gender-affirming surgeries, specifically metoidioplasty and phalloplasty. Participants should be in the decision-making process regarding these surgeries and willing to provide feedback on a new online decision aid tool.

Inclusion Criteria

I identify as a transgender male or gender non-binary.

Able to speak, read, and understand English at a sixth-grade level

Resides in the USA

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants are randomly assigned to either receive usual care or test the web-based decision aid. They will provide feedback on the tool's usability and its helpfulness in supporting decision-making.

4 weeks

Unlimited access to decision aid

Follow-up

Participants are monitored for changes in decisional conflict and decision readiness after using the decision aid.

2-4 weeks

Post-surgical Consultation

Participants' shared decision-making experiences are assessed using the CollaboRATE score after their surgical consultation.

Within 1 week

Treatment Details

Interventions

• MaPGAS Decision Aid

Trial Overview The study tests an online tool designed to help with decisions about Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS). It compares the experiences of those using this tool against those receiving standard care, focusing on user-friendliness and its impact on surgery readiness.

Participant Groups

Group I: MaPGAS Decision Aid Intervention Experimental Treatment 1 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.

Group II: MaPGAS Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Evaluating participants' use of a hormone replacement therapy decision-making intervention. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of an interactive multimedia decision aid on hormone replacement therapy in primary care. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

The effect of decision aids on the agreement between women's and physicians' decisional conflict about hormone replacement therapy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Can computerized decision support help patients make complex treatment decisions? A randomized controlled trial of an individualized menopause decision aid. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

A decision aid for women considering hormone therapy after menopause: decision support framework and evaluation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The gender identity/gender dysphoria questionnaire for adolescents and adults: further validity evidence. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostics, counselling and treatment in the context of gender incongruence, gender dysphoria and trans health : Practical information regarding the S3 guideline]. [2020]

8. England pubmed.ncbi.nlm.nih.gov

An MMPI subscale (Gd): to identify males with gender identity conflicts. [2022]

9. England pubmed.ncbi.nlm.nih.gov

'Taking the lid off the box': The value of extended clinical assessment for adolescents presenting with gender identity difficulties. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical management of youth with gender dysphoria in Vancouver. [2022]