Improving patient access, understanding and adherence to healthcare information: an integrated digital health information project

This is a future call currently planned to be published 26/06/2019. All information regarding future IMI Call topics is indicative and subject to change.

Specific challenges to be addressed

The ability to access and understand high-quality health information is central to health literacy, and this affects the day-to-day decisions citizens make in the management of their health and care that will ultimately determine adherence to treatment. A lack of adherence is an established public health concern, with significant effects on the individual patient, as well as healthcare systems as a whole.

A multitude of health-related information resources are now available to patients, tapping into demands for greater engagement with personal healthcare. This digital era, however, is compromised by two major concerns. Firstly, the sheer volume of available information has become disorientating to users, many of whom have poor health literacy to start with, and do not know which source to trust for up-to-date guidance. Distribution of this information across different source locations only compounds the issue. Secondly, existing health-related resources are generally not personalised to their specific needs or health literacy level, and therefore large amounts of the information available are irrelevant to the patient1 . Indeed, product information is a prime example of this phenomenon, with little direct evidence to suggest that patients are actively reading, understanding and adhering to details in the patient leaflet (PL). Bearing in mind that the product information is considered for most products to be the primary risk minimisation measure, this paradigm clearly needs to change.

There is therefore the need to lay the foundations for the application of digital technologies to health information in order to transform citizens’ understanding of their health and care, promoting adherence to prescribed treatment, and ultimately better outcomes. The proposed project is consistent with the EU Digital Single Market Strategy, which highlights the need and opportunity to introduce a digital transformation of health and care and is aligned with the IMI Strategic Research Agenda under Axis 4 ‘Patient Tailored Adherence Programmes’ . The project is also consistent with the key benefits noted in the EMA Action Plan on e-Product Information (ePI) and subsequently in the draft key principles for electronic product information published by EMA following an EMA/HMA/EC stakeholder workshop during which this project was presented alongside other initiatives in the context of a future vision for electronic product information in the broader digital health landscape.

Scope

The principle aim of the project is to demonstrate how the use of an integrated, digital, user-centric health information solution could transform how a citizen accesses and understands health information from different sources and applies this to be an active, empowered participant in their health and care. A secondary aim will be to measure how improved access and understanding of health information translates into higher levels of treatment adherence, safer use of medicines and consequently better health outcomes, with new insights into how health information can be optimised to act as an effective risk minimisation measure.

The project objectives will be delivered by a phased approach, in which later stages build on the outputs of the earlier research activities in an agile manner:

1. Establishing stakeholder needs

Research will be conducted to establish an in-depth understanding of citizens’9 expectations and aspirations for the provision of healthcare information in a digital setting to form the basis for future project activities and design-planning for technology development. Specific contexts/patient journeys will be mapped at this stage either on specific therapy areas or other product-type scenarios, such as nonprescription medicines or vaccines.

2. Technology platform and digital solution

Development of an underlying open source technology platform, and a digital solution to enable testing and measurement of the effectiveness of a digital approach to meet defined user needs. The initial focus will be on product information, Electronic Healh Records (EHRs) and a two-way communication channel with the patient. Appropriate, trusted data sources will be linked to the platform taking into account applicable data security and General Data Protection Regulation (GDPR10) considerations. A digital solution with tailored information in line with patient needs will be developed for the proof of concept testing of understanding and acceptability. Alignment with the key principles on the common standard for ePI coming from the EMA Action Plan will also be taken into account11 . Depending on technical progress with product information and EHRs, the latter stages of the project may include a wider range of trusted health educational materials (HEMs) within the platform, with the aim of further enhancing patient understanding.

3. Evaluation of the ability of digital solutions to enhance risk minimisation approaches through the generation of real-world evidence

Feedback gathered via the digital tool can be used to assess understandability and options can be evaluated for how to further assess the effectiveness of the platform as a risk minimisation tool.

4. Development and execution of a sustainability plan

A sustainability plan will be developed over the life of the project which details recommendations for how successful concepts/technology approaches will be carried forward and implemented at the national/regional level in a sustainable and practical manner.

Any form of promotional materials will not be in scope for this project

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