Electronic informed consent in practice: 
The Verkko trial and how eICF contributed to its success

27th July 2015 No Comments

Electronic informed consent (eICF) for clinical trials can no longer be considered merely “interesting but unproven”. The Verkko and Pfizer remote trials and their extremely interesting and promising results are changing that perception.

Miguel Orri, who led the Pfizer REMOTE study and wrote an authoritative whitepaper on eICF, worked closely with the team at Clinpal on electronic informed consent – and the resulting Clinpal solution helped drive multiple efficiencies in the Verkko trial. This includes rapid online recruitment via Facebook, fast-tracked online referral tracking, accurate, 100 percent remote electronic informed consent, convenient home delivery of study materials, easy online registration of connected, intuitive smart glucose meters with automated glucose profiling protocols, secure online messaging for patients and even a patient satisfaction survey. Adding to the convenience and to patient satisfaction, patients do not visit the physical study site at all. All of their training and coaching is either fully automated or remote. This, we believe, contributes to a reduced patient dropout rate, since happier patients are engaged patients, and engaged patients are much more likely to stay in the study.

The results for the trial’s patient workflows are impressive:

– Patients went from first point of contact to accepted and on to fully executed informed consent in an average of 9.3 days and the investigator spent only minutes per patient instead of hours

– The time it took for study material shipment, pickup from the post office, device registration and test reading was only an average of 12.9 days

– The start of profiling to completion of the study only took 16.4 days, roughly the same as in a previous manual trial. This time is driven by compliance, so this is an excellent result considering that the patient training and coaching was fully automated in Verkko

The key metric in the trial is the time it takes patients to successfully complete their profile. This requires them to set the time windows for their daily routines and then perform their glucose readings at the right times to form pair measurements. Pair measurements are used to calculate the excursion of blood glucose between the two readings and this is used as the input by the algorithms that then produce the final reports.

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Patient’s logbook view

To successfully complete the profiling process, patients need to perform the pair measurements correctly three times a day (overnight fast, breakfast and main meal of the day) for five days. Thus perfect execution would total a minimum of 25 readings, consuming five days.

Flexibility that adopts to the real world

The profiling process is patient friendly and flexible, and allows for patients to skip days not representative of their ‘normal’ days (parties, etc). Spreading the process out over a few days likely provides a better overall picture when compared to completing it in the minimum possible time. However, what is more important is helping the patients get through the process with the minimum number of readings. It’s also important to note that patients do not get any hands-on training or explanation of this process from the study staff, thus adding to overall efficiency and cost savings. They only rely on the information received in the electronic study materials and fully automated coaching by the smart glucose meter.

One key: Patient understanding of the material

One of the biggest surprises was how well patients understood the profiling concept, considering that they don’t get in-person training. This may even have been a benefit. My theory is that when patients study this kind of complex information, they may understand it better when they do it at home and have time to think and consider, without the pressure and distractions that are present during a site visit.

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Sample eICF

The successes of remote proactive management

As expected, not everyone “got it” right away, with the average age in the study being 59 years, with several 70-plus patients. This is where the proactive, remote patient management helped. Thanks to the Clinpal solution, the study coordinators in Verkko were able to monitor patients and intervene as soon as it was clear someone wasn’t following the process.

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Logbook view with just one correctly done pair

In the above example, the patient was contacted via Clinpal and provided with instructions on how to start performing the measurements at the right time. They were trying to do it right, but were simply performing the second pair measurement slightly too late. It was a simple adjustment, which the patient made quickly thanks to the Clinpal reminder.

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Logbook view with all pairs done correctly

So far, 46 patients have completed the study. Only two out of 51 patients sending data have dropped out, which compares well with the industry average and is a good indication that patients are well informed and engaged to put in the significant effort to participate in the study.

Engaged patients contribute to a successful study

Patient satisfaction metrics are impressive, as measured on a scale of 1-5

Clinpal ease of use: 4.3

Ability to perform your tasks using the software:  4.64

Satisfaction with the wireless glucose meter: 4.64

Overall satisfaction with your study participation: 4.78

Said one patient: “Fantastic idea. I’m sure it saves a lot of time and also makes things easier for the doctors.”

Conclusion: Remote studies are efficient and patients love them

The use of an electronic informed consent in the Verkko trial clearly was a significant contributor to the study’s success. Thanks to the eICF and Clinpal, it was a very efficient process for investigators and patients. Most importantly, it exceeded expectations in terms of educating the patients about the study and in some cases performed better in education than the on-site personal training used in a previous study.

Patients liked the simplicity and the fact that they could avoid the time and trouble of site visits. Overall, conducting the study remotely saved time and money, since doctors and nurses didn’t need to organize special visits for study familiarization and for informed consent.

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