Best Practices to Improve the IRT Site User Experience

Editor's Notes

• #3: • Assess current challenges for sites with arrivals, dispensing and returns tasks • Automate temperature excursion and inventory management tasks • Evaluate future advances to enhance product quality data before dispensing
• #4: This is about ensuring audience has a consistent understanding of the subject. Quality of experience a person has when interacting with a specific design Useful. As practitioners, we can’t be content to paint within the lines drawn by managers. We must have the courage and creativity to ask whether our products and systems are useful, and to apply our knowledge of craft + medium to define innovative solutions that are more useful. Usable. Ease of use remains vital, and yet the interface-centered methods and perspectives of human-computer interaction do not address all dimensions of web design. In short, usability is necessary but not sufficient. Desirable. Our quest for efficiency must be tempered by an appreciation for the power and value of image, identity, brand, and other elements of emotional design. Findable. We must strive to design navigable web sites and locatable objects, so users can find what they need. Accessible. Just as our buildings have elevators and ramps, our web sites should be accessible to people with disabilities (more than 10% of the population). Today, it’s good business and the ethical thing to do. Eventually, it will become the law. Credible. Thanks to the Web Credibility Project, we’re beginning to understand the design elements that influence whether users trust and believe what we tell them. Valuable. Our sites must deliver value to our sponsors. For non-profits, the user experience must advance the mission. With for-profits, it must contribute to the bottom line and improve customer satisfaction.
• #5: Pie chart comparison is an abstract concept but can be related to audience experience of real life everyday examples. Helps explain the topic. Pie charts as a concept fail on several key elements of user experience. They are not useful, credible or valuable. Difficult to compare data Can skew/distort data – especially when 3D Doesn’t scale well beyond 2 items Hampers decision making Bad UX: Clickbait Roadblock to content (adverts, surveys etc) – Distractions Autoplaying
• #6: Bar chart quickly demonstrates how putting thought in UX allows a UI solution that provides the information users require quickly and easily Know your users – research, testing, concept validation Goals Test and more Test Feedback
• #7: Moving on from theory now and starting to put this into IRT context. Linear – one input at a time, little scope for performing bulk tasks or for users to find different paths through the system Input burden – simple UI, since web layered on voice the input paradigm is based on single digit input, very limiting Navigation – no idea where you are in the system, in the process. Very little in the way of feedback about what you need to do next or assistance with self discovery Speed – have to wait prompts to read out, menus are long. For web – some pages were one input at a time
• #8: This is discussing the challenges and complexities that Site IRT users face. First how technology changes are shaping the landscape and expectation of users. We obviously live in a highly connected ecosystem of smartphones, wearable and other devices that are used by people in their everyday life. We also live in a world dominated by cloud computing, big data and analytics. Whilst our industry is clearly starting to understand how these technologies can improve clinical discovery and development, the clinical trial space is still behind adoption in other industries or is using the approaches the technologies offer, without connectivity or ability to exchange data in near real time or ability to use data collected over many trials to optimize design and implementation.
• #9: This is discussing the challenges and complexities that Site IRT users face. Second how the real life processes that Site Users have to follow make designing good UX for IRT difficult. There’s a lot of administrative work using multiple forms, files and systems to process shipment arrivals, allocation & dispensing, and returns and reconciliations at clinical trial sites. PAREXEL recently commissioned detailed site visits to view and record these activities. With arrivals, there are often two main stages that can be anything from a few minutes to a number of hours apart. Firstly the initial arrival and unpacking process where loggers (for temperature and other environmental factors) and delivery paperwork are removed, and data is downloaded from the loggers. And the kits are moved to temporary storage. The second stage is processing of the arrivals, involving many steps including checking all kits are present as per delivery note, completing necessary paperwork or spreadsheets, including the accountability log; and logging the arrival in the IRT system, including upload of any logger data. Finally kits are moved into storage for dispensing or quarantine as appropriate. Kit allocation – patient arrival checked and logged. Prescription (paper) completed and signed by doctor. Kit allocation made and dispensation started in IRT system. Kit number written on prescription. Dispensing – Pharmacy receives email from IRT system. Study nurse takes prescription to pharmacy. Cross check patient details with study log. Cross check kit number with IRT email. Fill in prescription labels. Fill in various paper logs. Collect kit from storage. Check study ID and kit number against prescription. Label the kit. Complete accountability log including any time out of fridge if relevant. Update subject log. Verify kit and confirm dispensation in the IRT system. Call study nurse to confirm prescription ready for collection. Returns and reconciliations – Again there can be significant delays between the time medication is returned and when the accountability processing is done. The study nurse takes returned medication kits to the pharmacy and put into temporary storage for later processing by site staff (pharmacy technician for example). When site staff are available to process returns, the remaining medication is counted / measured and recorded on kit label, in accountability log and in IRT system. In all of these processes there are lots of opportunities for manually recorded data to be incorrect or inconsistent across paperwork, files and the IRT systems -------------------------------- If we think of the clinical trial site, and the main functions the site performs in the clinical supply chain – i.e. Material receipt and inventory, allocating and dispensing materials to patients and accounting and handling returns and reconciliation – again all of these processes are quite complicated, require sites to work across multiple systems in some cases or are still largely paper based, can be time consuming and can also be prone to critical error such as an incorrect kit allocation to a patient. I won’t spend time talking about the detail in each of these functions but I think we will all agree that in all of these processes there are lots of opportunities for manually recorded data to be incorrect or inconsistent across paperwork, files and the IRT systems. Let me show you how the IOT and in this case mobile technologies can assist.
• #10: Opportunity to discuss what we have done to understand our users with a focus on site arrival process. User Personas Interviews Observations Task Tracking User Testing A sample of type of research that we have been carrying out. Test, test, test strategy Understand users is paramount
• #11: Diving into the site arrival general process to illustrate how you tie an understanding of the process with applying technology to provide good user experience. Current Process Find out if shipment has arrived – check with reception or receive late arrival alert. This could be typically be done by a study nurse. Collect shipment Enter shipment details and confirm status in IWR Plug in logger and upload temperature data For each medication pack, enter details and confirm status in IWR Place medication in stock for use
• #12: Conventional supply chain monitoring uses temperature loggers where you need to wait for the shipment to arrive at the site to see there’s a temperature alert, and then download the data from the device by connecting to USB port. The report is often simply a PDF. This approach can lead to delays in being informed about temperature excursions, investigating them and taking action to either mark as damaged or release medication. These delays have the potential to impact patient safety and trial integrity if drug is not available for a patient visit.
• #13: Improved process. With RTSM app and real-time temperature monitoring Automatic alert on arrival from location tracking Collect shipment Scan and confirm shipment. Temperature data for the shipment is already available in the cloud (collected by real-time logging devices) Scan and confirm packs Place medication in stock for use Focus on how to make data editing efficient, easy and functional why bother editing at all?
• #14: Real time loggers that can transmit temperature and location data regularly to our IRT system, allowing sites to process arrivals quicker, sponsors can analyze excursions easier, and medication can be released sooner. For mobile, highlight benefits.
• #15: Real time loggers that can transmit temperature and location data regularly to our IRT system, allowing sites to process arrivals quicker, sponsors can analyze excursions easier, and medication can be released sooner. For mobile, highlight benefits.
• #16: Cloud Bluetooth Wearables Analytics Patient Direct Access to more data: Environmental factors, different devices (fridges) etc Physical gestures Augmented reality