My Decision/Mi Decisión: Evidence-Based Digital Decision Aid for Informed Permanent Contraception Choices

This patient-facing, web-based tool is designed to support informed and value-concordant decision-making for individuals considering permanent contraception, specifically tubal sterilization. This scalable technology has been proven in a randomized clinical trial to significantly increase patient knowledge and reduce decisional conflict, offering a powerful, evidence-based safeguard against suboptimal decision-making for a high-stakes procedure.

Description

This innovation is a patient-centered, web-based tool available in both English and Spanish, developed systematically according to international standards for patient decision aids. The tool operates by guiding the user through several interactive sections to ensure full comprehension and clarity on their reproductive goals. It provides comprehensive written, audio, and video information covering both the permanent contraception procedure and alternative contraceptive methods. Key features include an interactive table for comparing contraceptive options, structured values-clarifying exercises, and knowledge checks. At the end of the process, users receive a personalized summary report that captures their knowledge, certainty, and preferences, which they have the option to share with their healthcare provider to facilitate an optimal counseling discussion.

Applications

- Clinical Practice Integration: The technology can be implemented into existing clinical workflows to supplement and enhance practitioner counseling for permanent contraception.
- Enhanced Consent Process: It can be adopted by healthcare systems as an evidence-based process to improve the quality of informed consent for preference-sensitive medical decisions.
- Regulatory Compliance Tool: A future application could include testing the decision aid as a streamlined, evidence-based replacement for the current mandatory consent process for federally funded procedures.
- Diverse Population Expansion: The platform is adaptable for use with other populations who may also be considering permanent contraception, including people who have never been pregnant, young people, individuals with disabilities, and sexual and gender minority groups.
- High-Demand Patient Support: It provides an urgently needed tool to address the growing demand for permanent contraception services.

Advantages

- Significantly Improves Patient Knowledge: In a randomized clinical trial, use of the decision aid significantly increased patient knowledge about permanent contraception by a mean of 20.8 percentage points compared to usual care.
- Reduces Decisional Conflict: The tool decreases patient uncertainty, leading to greater confidence and less conflict in making a final contraceptive choice.
- Supports Value-Concordant Decisions: It guides users through structured reflection and clarification of personal values to ensure their decision aligns with their preferences and life goals.
- Provides a Scalable Safeguard: It offers an evidence-based, scalable solution to help ensure that patients have a complete understanding of the procedure's permanent nature and their alternatives prior to consenting.
- Offers Lasting Educational Effects: The benefits in knowledge and reduced decisional conflict persisted for months after the initial intervention, carrying lasting benefits to the time of surgical decision-making.

Invention Readiness

The technology is at a mature stage, having been fully developed, beta-tested with end users, and its efficacy rigorously evaluated through a multisite, parallel-arm Randomized Clinical Trial (RCT). The RCT, which included a large number of participants, generated robust data demonstrating the tool's effectiveness, showing that it resulted in a large increase in knowledge and a small-to-medium improvement in decisional conflict when compared to usual care. For next steps, further studies are needed to explore a full implementation trial that would test the decision aid in place of the current consent process, aiming for a more streamlined approach. Furthermore, ongoing development is committed to adapting the tool's content and design for use with diverse populations, including those who have never been pregnant and other underserved groups.

IP Status

Related Publication(s)

Borrero, S., Mosley, E. A., Wu, M., Dehlendorf, C., Wright, C., Abebe, K. Z., & Zite, N. (2024). A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women. JAMA Network Open, 7(3), e242215. https://doi.org/10.1001/jamanetworkopen.2024.2215

Mosley, E. A., Zite, N., Dehlendorf, C., Deal, A., O’Leary, R., Achilles, S., Barnato, A. E., Hall, D., & Borrero, S. (2023). Development of My Decision/Mi Decisión, a web-based decision aid to support permanent contraception decision making. PEC Innovation, 3, 100203. https://doi.org/10.1016/j.pecinn.2023.100203