Speaker
Michael Gibson
Professor of Medicine Harvard
Interventional Cardiologist BI Lahey
CEO & President of the non-Profit Baim Institute for Clinical Research & PERFUSE Study Group
Keywords
Pragmatic Clinical Trial, Heartline Trial
Key Points
- The Heartline Trial is one of the world’s first randomized virtual trials. It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?
- The Heartline Trial has moved to a new form of information sharing, one that is open source, innovates from without, knowledge flows to and from all via the internet, people can share information, retaining credit for it but sharing it freely. The new way is more collaborative and global. The biggest change is that the patient now has a seat at the table. Providers must now earn the trust of relatively informed and knowledgeable patients through a two-way conversation.
- The Heartline Trial is a randomized trial of up to 28,000 patients to test whether the new Apple watch (with built-in single lead EKG) can detect new onset atrial fibrillation in participants age 65 and older.
- Patients were enrolled via an app in this virtual trial. Patients were followed-up online by apps for Patient Reported Outcomes and claims database. The consent form is electronic and approved by a central IRB.
- Heartline is using direct to patient recruitment and includes real world patients with a broad range of modifiable risk and limited exclusion criteria. The study is enrolling people where they are using social media, such as Facebook ads, twitter influencers, tv ads, interviews with print/electronic news outlets, national tv (an appearance on “The Talk” to discuss the study), targeted advertising, physicians, electronic health records.
- In this new trial model, we don’t have to track down missing information unless the patient leaves the country. We are empowering the patient and family, who have access to their data. The family can be notified if the patient goes into Afib. There also is no need for an independent clinical event committee to adjudicate events. In the new model we are using ICD-10 codes, not specific to the trial, to find events and lead to lower specificity, more events. In Heartline, patients will be reimbursed for effort to complete patient reported outcomes and interacting with the app.
- Digital health is upon us, and we want to make sure that technology works for healthcare and that healthcare should not work for technology. Digital health should complement nurses and physicians by putting patients back at the center of trials
Discussion Themes
– One of the things you noted is how sticky the app was and the excellent completion rates of the data. To what extent were you observing the methods for providing value to the patients through the app actually changing the observed function? The engagement with the original Apple health study was not good, about 30-40%. In Heartline, the older population engaged much more than I thought they would, 90% engagement initially and fell after a few months to 80-85%. It was achieved because it wasn’t just them answering questions. There was news pushed out about general health. They liked being kept up to date about general medicine and this provided value to them. We asked why are you participating and engaging with the app? They wanted to give back and help others learn something. It’s so important to maintain patients trust and credibility to them.
– There are systems in place to ensure equipment used in clinics are reliable. How do you account for the lack of oversight in the remote setting? What kind of trials would this be suitable for? If you are doing biomarker work, patients will have to go to a brick and mortar for that. But for outcomes and others you can do virtually. I think you’ll probably end up with a hybrid model. Consent is one that should be done virtually.
Tags
#pctGR, @Collaboratory1