Learn more about the Office of the National Coordinator for Health Information Technology’s eConsent Trial Project, which addressed patient questions surrounding consent and provided a way for patients to exercise their consent decisions electronically.
The ONC eConsent Trial Project developed and implemented electronic and innovative ways to:
- gather patients’ input on areas in which they want to learn more about consent,
- educate patients in a provider setting about the electronic sharing of their health information through a health information exchange organization (HIE), and
- capture and record choices patients make.
The eConsent project provided specially designed patient education materials and electronic decision capture technology at four health care provider offices that participate in a regional clinical information exchange. Patients at these offices had the option to use tablet computers to review the interactive educational material and electronically make their consent choice.
The eConsent Toolkit presented here provides samples of the tools, resources, and educational materials that were used in the project. They represent just one method of enabling patient education and engagement for meaningful consent.
The Toolkit is divided into categories of Planning Resources; Educational Materials, Texts and Stories; and Technical Tools.
- Planning Resources
In gathering information from patients about what they need to know to make a meaningful consent choice, the eConsent Trial Project distributed a regional patient survey and conducted regional patient focus groups. The eConsent Patient Input Survey [PDF - 180 KB] is available in the Toolkit as one example of how to design a survey to gather information on patients’ educational needs.
The Focus Group Facilitator’s Guide [PDF - 473 KB] provides an example of how to use a focus group approach to gather patient input.
When planning to implement the patient education and engagement part of meaningful consent, there are many factors to consider. While each consent program is different, the Toolkit’s Practical Implementation Tips for Meaningful Consent [PDF - 160 KB] document, which was informed by the eConsent Trial Project, provides implementation insights that may be helpful.
- Educational Materials, Texts, and Stories
The video (non-interactive) versions of what patients viewed on the tablets are available for viewing in the Toolkit (“Educational Materials”). The text (“Texts for the Educational Materials” [PDF - 545 KB]) used to create the materials can be downloaded from the Toolkit as well.
The interactive educational materials (also called “stories”) created in Story Engine were delivered to eConsent patients through tablet computers. These “Sample Stories” [XML - 31 KB] are available for downloading in the Toolkit, but should be customized to a user’s specific environment before being used in a patient education scenario.
- Technical Tools
The eConsent Trial Project used an open-source, web-based application, called Story Engine, to develop and present its interactive, electronic patient education material.
The Toolkit contains the eConsent Story Engine download [ZIP 1.5 MB] as well as the technical standards needed to download/house the tool (“Architectural Analysis and Technical Standards” [PDF - 586 KB]) and guides for installing and using the tool (“Installation Guide” [PDF - 82- KB] and “User Guide” [PDF - 2.65 MB]).
Story Engine can be used by providers, health information exchange organizations (HIEs), and other health IT implementers across the country to educate their patients on various topics in an interactive manner. Story Engine’s open-source nature allows it to be used without additional licensing fees. Because non-technical authors can develop content, Story Engine can be used to develop different types of patient education, for example:
- Patient education on consent in electronic health information exchange (eHIE)
- Health Insurance Portability and Accountability Act (HIPAA) patient education – what HIPAA is, patient rights under HIPAA, delivery of Notice of Privacy Practices (NPP)
- 42 Code of Federal Regulations (CFR) Part 2 patient education
- Patient pre- or post-procedure education (e.g., how to take care of stitches)
Implementers can use the Story Engine to help patients understand various topics such as those above. However, if they plan to transmit patient information (e.g., a consent decision) to an HIE, they will need to develop custom interfaces that are compliant with applicable laws and regulations. Due to the variability in methods for HIE data transmission, the HIE interface is not part of the Story Engine tool.
- eConsent Patient Input Survey [PDF - 180 KB] – an example of a survey to gather information on what patients need to know before they make a meaningful consent decision.
- Focus Group Facilitator’s Guide [PDF - 473 KB] – an example of how to use a focus group approach to gather information on what patients need to know before they make a meaningful consent decision.
- Practical Implementation Tips for Meaningful Consent [PDF - 160 KB] – things to consider when implementing the patient education and engagement part of meaningful consent.
- Educational Materials – the educational materials patients viewed on a tablet prior to making a consent decision. The materials can be viewed in the Meaningful Consent Video Gallery.
- Texts for the Educational Materials [PDF - 545 KB] – the language for all the eConsent patient educational material.
- Sample Stories – the interactive educational material that patients viewed on a tablet computer during the eConsent Trial Project. The sample stories contain functionality (e.g., patient navigation, e-signature) and are available for download here [XML - 31 KB]. An installation of the Story Engine Tool is needed to view these stories.
- eConsent Story Engine Tool [ZIP - 1.5 MB] – combination of the authoring tool used to create stories and the interface used to view created stories. The tool has the ability to display educational material and electronically enable signature capture of patients.
- eConsent Story Engine Tool Tutorials (videos) – a video series that shows the eConsent Story Engine Tool from an implementer's perspective.
- Architectural Analysis and Technical Standards [PDF - 586 KB] – the summary of the integration of computer software and hardware only as it pertains to Story Engine installation on a web server.
- Installation Guide for eConsent Story Engine Tool [PDF - 820 KB] – the instructions for installing the open-source Story Engine tool. Consider browser/mobile device compatibility as well as the availability of a server or other place to house the databases and reporting structures that go with the download of the tool.
- User Guide for eConsent Story Engine Tool [PDF - 2.65 MB] – the instructions for how to author/develop educational material using the Story Engine tool.