Augmented Reality in patient communication – don’t miss out!

It’s probably quite obvious to say that using technology in a real practical way will improve patient communication and engagement and speed up clinical trials. 

However, if you take a pragmatic view to innovation within your business practices, quite rightly assessing how much time and budget will it take to adopt and move into more innovative approaches, and assessing if the payoff is worth it, the concern might be that you may have already missed out. 

New technology has already allowed us to move from traditional hard-copy documentation to electronic versions, which are then further adapted into multi-media formats to be viewed on tables or smart phone with links to videos, audio tracks, and even developed into games and apps.

It is also quite well accepted that improving communications during a clinical trial can lead to better sign-up, compliance, happier patients and better results (leaving aside the possible increase in the placebo effect due to increased patient engagement).(1)

Improved patient engagement can be achieved using electronic platforms such as websites, e-PRO systems, social media interaction, informative emails and texts. There have also been innovative approaches such as designing apps just for a particular study, or even a whole computer game that allows the patient to advance only when they carry on with the trial in full compliance. All of these approaches can be very effective, but they raise a few questions including:

• What level of disruption is affordable and comfortable for a company running a trial?
• Can you afford the cost and risk of shifting your whole communications to an electronic platform?
• Do you still need some hard-copy documents for patients who are not at ease using computers or smartphones?

Adapting current trial processes effectively to include electronic options – Patient information documents 

One approach that I find intriguing is to use the current well established processes in parallel with an electronic approach to get the advantages, but limit the cost and risks of change. All hard copy documents are also available as electronic versions (generally PDFs), and these can be adapted and displayed easily on tablets and smartphones. The approved hard-copy versions of patient communication documents could easily be used by the patients and healthcare professionals if distributed to the reading devices in a controlled way. The advantages can include time and control. Printing and distributing hard copy documents takes time (typically 5-10 days) and this time could be used to get a head start on patient recruitment if the approved documents were distributed immediately electronically via the web.

However, there is the issue of access and control – how can you make it easy for the patient or professional to find the correct document? How can you ensure they are using the right document if they have multiple studies going on? How can you ensure the electronic file is not sent out in an uncontrolled manner, for example if sent via email to another country where the version is not approved? These are some of the real, practical issues that can cause CROs to hold back on technology use.

One approach to controlling the distribution of approved electronic files could be to use ‘hard copy’ linkers or ‘title cards’.

By way of an explanation, let’s take a typical study and call it the ‘TECHY’ Study.
If your study has 12 recruitment documents, you design and distribute a country specific title card for each document whilst the documents are being approved, such as the ‘TECHY Patient Info Document’, or the ‘TECHY Informed Consent guide’.

The title card has either a recognisable visual tag, such as the study branding and text title, or a QR code.

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DO TRY THIS AT HOME!
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Why not try a demo of ‘controlled access’ to a clinical trial information document via an App.
Instructions for the demo:

1. Download the ‘LAYAR’ app to your phone or tablet.
2. Open the app and aim your smartphone or tablet at the ‘TECHY study title card’ below.
3. Click the screen to scan the card.
4. The ‘trial’ document should then appear, with a ‘carousel’ of different languages

Note: LAYAR is a free, publicly available Augmented Reality App. However, Conversis can develop and offer a personalised App for your specific study or company.
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As soon as the documents are approved, the healthcare professionals and patients can then use the title/code card to immediately access the approved document over the web via an app that you control. In that way, you keep control of the version that is being accessed and used, the document cannot be downloaded or distributed in an uncontrolled manner, and there are no ‘old hard copy’ versions ‘floating’ around.  This can then be followed up with hard-copy documents when they are printed and ready, but this compromise between electronic and hard copy documentation is an effective way of gaining the advantages of easy and quick distribution of electronic files, with immediate updates when needed and control of distribution of the files. However, it doesn’t need the CRO to immediately change their current well-established workflows.

Electronic Informed Consent Forms (e-ICFs) and Electronic Data Capture (EDC)

In a recent well written article, Pierre Corin from Genentech discussed the drivers, advantages and possible challenges of using electronic Informed Consent Forms.(2) He quoted a really relevant FDA definition from March 2015 ‘“electronic informed consent refers to using electronic systems and processes that may employ multiple electronic media (text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent. Advantages of using this type of e-ICF apply to patients (or subjects), investigators and staff”.   The FDA are therefore aware and happy with the use of electronic communication, providing it meets the standard in-place, requirements of the regulated environment.

Corin also highlighted similar advantages for ‘e-consent’ forms as listed above, such as the opportunity to use a mixed media to communicate a technical message, portability of the consent form on the patient’s own device, possibility of a survey style response from the patient/reader to assess the subject’s comprehension, enhanced control and speed of rolling out updates to the ICF, and finally improved control and quality of the data collected. He also mentioned a few challenges such as extra development cost and time taken for an e-consent form. However, Corin views this as an investment that should result in better quality experience for both sponsors and subjects.

As with all technology, there are issues with learning the use of the technology and the technical aspects such as defence against data hacking and loss and compliance with the FDA CRF part 11.

Overall, there is a growing consensus that the advantages of the e-ICF or e-consent outweigh the challenges and an opinion echoed by Brian Bollwage from Chiltern CRO in his recent talk at the OCR conference in Raleigh, NC, USA stands as a reinforcement.(3)

The field and options for ‘Electronic Data Capture’ are plentiful and complex and it would be impossible to discuss the whole debate here on whether it’s best to run your whole trial electronically or via paper-based systems. There are many advantages to an electronic data capture approach, but one example I found particularly interesting was from Canadian based eClinical solution provider, Axiom Metrics, who state on their website that: “With the right Electronic Data Capture tools in place Sponsors realize cost savings, time savings and have transparency to all aspects of study data in an instant. Paper trials the delay in access to data can range from weeks to months, and cost millions in lost sales.”(4)

However, the key to successful electronic systems is often the significant extra investment cost needed. In my own past experience, I came across a company who put up with the GMP requirements of keeping duplicate paper copies of every piece of data, simply because the cost of getting in an “FDA CRF part 11” compliant computer system was many times in excess of a photocopier, and junior filing assistant and a storage cabinet. (Note: ‘GMP’ can stand for ‘Good Manufacturing Practice’ or ‘Great Mountains of Paperwork’!). So a decision on whether to adopt new technology will always have an opportunity cost and disruption element.

Conclusion

There is no simple answer to when to pull the trigger on adopting new technologies, other than soon! However, I am convinced that digital mobile technologies offer significant advantages, and with careful and staged implementation, the costs and disruption to your current workflows can be minimised and the improvements in patients’ engagement, recruitment, retention and compliance can be realised.
Simple, already tested and available technology platforms can be used to share the currently available electronic versions of hard-copy files, in a simple 2-dimensional manner at first, as demonstrated in the ‘Do try this at home’ example below. The extra multi-media and multi-dimensional technologies can be added to these platforms when ready, fully tested and available.
 
References:

1. http://www.nature.com/news/strong-placebo-response-thwarts-painkiller-trials-1.18511
2. http://www.clinicaltrialsarena.com/news/operations/the-rise-of-the-e-consent-form-4754154, Pierre Corin, Genentech.
3. “Electronic informed consent – improving patient engagement”, Brian Bollwage, JD, VP Global Regulatory Affairs, Chiltern CRO.
4. http://www.axiommetrics.com/eclinical-services/paper-to-edc/

A version of this article was published in the May edition of International Clinical Trials - European Pharmaceutical Contractor

Dr Mark Hooper is a director at Conversis Medical. For more information visit conversis.com