W 19: Implementing and Monitoring the Use of Interactive Risk Communications
Head of Development Consulting
Pope Woodhead United Kingdom
In the EU, GVP XVI requires effectiveness evaluation of risk minimisation measures. As this is difficult to achieve for paper-based communications we are exploring how to better engage users and collect rich effectiveness data through interactive web-based applications.
We are deploying interactive apps that educate HCPs and patients about the appropriate use of a drug requiring sterile preparation and administration at home. The apps collect utilisation and patient knowledge data useful in assessing implementation success and effectiveness of educational content.
We deployed web-based educational applications for healthcare professionals and their patients to encourage the appropriate use of a drug. The education is provided in 17 local language variations (34 URLs).
• The HCP focussed tool provides important risk minimisation education related to appropriate preparation and self-administration of the drug at home for patients they believe capable of following instructions. The tool is used during self-education and patient training. To augment the guidance, links to product labelling and downloadable PDF guides are included. HCPs can access the patient version of the tool to demonstrate relevant sections of the resource to patients.
• The Patient apps offer detailed training on the sterile preparation and administration of the drug through short training sections used either for self-education or as stepwise guidance followed when taking the medicine. To augment the educational content, users can download printable materials and answer quizzes covering key safety messages.
• The apps collect anonymised utilisation data from each user every time they are accessed. This data is used to evaluate the effectiveness of the initial deployment, ongoing use and patient knowledge. Data collected includes:
o Utilisation of each of the country/language variants to assess the effectiveness of publicising their availability across markets
o Frequencies of repeat uses and timing data provided by anonymised individuals (e.g. HCPs using the application for training or patients accessing guidance during a self-administration event)
o Download frequencies or use of links to product labelling to show the value of supplementary data
o Healthcare professional feedback on the utility of the apps for managing risks
o Improvements in patient’s knowledge with repeated use via quizzes is used as a surrogate for behavioural outcomes
This is the first multi-lingual pan-European web-based risk minimisation platform collecting real-time effectiveness data. The system delivers important advantages over paper-based tools and PASS surveys.
1. They provide a richer end-user experience increasing engagement and likelihood of re-use.
2. Collecting data from all users gives a more representative evaluation of efficacy than via commonly employed surveys. Actual utilisation behaviour rather than stated behaviours from surveys (limited by recall and social desirability biases) is observed.
3. The uptake and use of the materials can be monitored regularly, which is not possible with paper.
4. The status of implementation and value of publicising these apps is easily assessed through monitoring HCP and Patient registrations.
5. Repeat use, sections visited and timing data delivers insights into how tools are used (e.g. initial self-training, HCPs training patients, patient’s use during an administration event)
6. HCP feedback helps understand their perspective on app’s utility.
7. Download frequencies and access to labelling demonstrates the usefulness of supplementary information.
8. Embedded knowledge tests provide an opportunity to educate patients and measure their understanding of key risk messages within the guidance. Monitoring responses longitudinally, e.g. via repeat knowledge tests, can show evidence of learning.
Monitoring the effectiveness of implementations and the effects of the educational content of these applications allows pharmaceutical companies to manage risks proactively. Data can help to determine corrective actions needed to improve tool uptake or raise users’ knowledge. Feedback from embedded surveys help understand end-users expectations of the educational materials. The wider adoption of these proactive approaches necessitates the development of new capabilities, processes, governance mechanisms and people in order to maximise the patient benefits they can deliver.