Last year, Apple announced the results of the Apple Heart Study, an ambitious digitally-enabled research project that also tapped the talents of Stanford University, BioTelemetry, and telemedicine company American Well. Through the study, more than 400,000 individuals helped Apple and Stanford learn about atrial fibrillation, and the predictive and therapeutic value of the Apple Watch’s algorithms.
At HIMSS20 next month, American Well General Manager for Strategic Solutions Dr. Jeff Kosowsky and Stanford Associate Professor of Medicine Dr. Mintu Turakhia will discuss lessons learned from the study and how the landmark study could have repercussions much bigger than a consumer wearable.
“What the New England Journal was all about was really a cardiology study with a little footnote about ow this was done virtually with an Apple Watch,” Kosowsky told MobiHealthNews. “But what’s really unique here is how this has been done differently from other studies. That’s what was interesting in the first place to the FDA, to the four parties involved, and to the industry. So what we’re going to be talking about here is what I think is the real new part, the story that wasn’t told.”
The Apple Heart Study demonstrated a proof of concept for a new kind of research study, Kosowsky said. Not just a traditional trial with digital add-ons, but a new kind of remote trial built from the ground up.
“This is not an angle of how a CRO becomes digital,” he said. “It’s really more of an angle about how consumer companies take competencies that are more in the clinical or consumer space and creates a new notion of the clinical study, one that can have 400,000 participants. One where the actual people from Stanford Cardiology never spoke to a single patient.”
So what were the lessons learned from this new experience? Kosowsky cited four.
One, organizations should emphasize and prioritize collaboration, and recognize ahead of time that research institutions, consumer companies, and digital health firms all have different ways of operating and it may not be natural or easy to synthesize them together.
Two, when dealing with such large numbers of patients, it’s important to automate as many of the processes involved as possible.
Three, Kosowsky said, organizations should shift their thinking from enrollment to a mindset of consumer engagement. That’s what he chalks up Apple’s success in recruiting so many participants to.
Finally, in the model they used it’s important to make sure providers are engaged as well, and give the study as much attention as their other duties.
“The provider perspective is really important because one of the ways we made this work is sort of brains and muscles,” Kosowsky explained. “The Stanford providers were the brains, but they never spoke to any patients. The muscles were providers from our network that we got to recruit. So the patient before may have been someone with a headache and the person after may have been a person with an allergy and they are providing urgent care/primary care, so we have to have also the provider experience, which means we have to make sure the providers are motivated and don’t see this as an undue burden.”
Kosowsky and Turakhia will present “Digital Models and Telehealth for Clinical Trials Evidence” Wednesday, March 11 at 1:00 PM in Room W414D.