By Van Crocker, President of Healthagen Outcomes
A new study, mHealth Screening to Prevent Strokes (mSToPs), conducted in part by Aetna’s Healthagen Outcomes unit and published in July 2018 in the Journal of the American Medical Association, demonstrates the influence of in-home digital cardiac monitoring on patient care. Equally significant, the work represents a critical, new pragmatic study design that delivers real-world evidence of the impact of health information technology on health care and outcomes.
Clinical research trials face significant challenges, and a large majority of trials are delayed due to insufficient enrollment.1 Reasons are varied. Consumers do not know about the trials or are not the right fit. Eligibility can be limited based on geography, as traditional trials are often conducted in select sites.2 Studies that examine the impact of a treatment in routine clinical practice, including emerging health IT and digital solutions, face even more challenges due to data collection from participants and providers.
The time, generalizability and cost of traditional randomized clinical trials — a necessity for evidence-based medicine — are not fully aligned with the rapidly evolving world of health information technology. The resulting lack of clinical evidence is likely preventing the actual application of new technologies in routine care. In an editorial about the mSToPS study, authors Peterson and Harrington challenge: “To cross this chasm, the current medical evidentiary processes must adapt to match the rapid discovery and innovation cycles of the IT world. Researchers need to make [randomized clinical trials] more efficient, patient-centric, and pragmatic—ready to take on the coming tsunami of new health technologies.”3
The mSToPS randomized clinical trial, conducted by Healthagen in support research partners at Scripps Translational Science Institute and Janssen (a pharmaceutical sector of Johnson & Johnson), is one of the first study designs aimed at delivering evidence of a contemporary digital device’s impact on care and outcomes in a real-world setting.
The study evaluated whether individuals who are at increased risk for atrial fibrillation (AF) and used a home-based, self-applied ECG patch facilitated an improved AF diagnosis rate compared to routine care where individuals were not monitored. The results say “yes” and could possibly help clinicians understand how best to detect AF easier and earlier. The study also showed that the increase in diagnosis led to increased preventive actions such as medication and clinical consultations. A more complete study of health outcomes impact will be completed after three years of monitoring.
Janssen, the study sponsor, appreciated that finding participants, collecting patient data, and evaluating the devices’ impact on care for a study like this would have been difficult, time consuming and costly without a novel approach. Janssen had also previously conducted surveys and other consumer research they believed would help with enrollment in a new trial. For example, email was the most preferred method of communication among consumers likely to participate in a trial.4 Additionally, minimal travel and time commitment, home testing, and digital communications were indicated as important engagement factors.5
Researchers at Janssen, Scripps and Healthagen combined these ideal trial design elements with Aetna’s critical patient targeting data and engagement and evidence collection capabilities, resulting in a novel direct-to-participant approach:
- Eligible participants were at higher risk of AF and were identified using Aetna’s claims data, resulting in an effective, efficient screening process
- Eligible members were invited to participate via email and letter, which significantly sped enrollment and commencement of the study
- The wearable devices were mailed to participants, greatly expanding the geographical reach into more areas well beyond a clinical trial center and providing at-home convenience
- The digital devices provided data directly from the participant, in real time
- Participants were empowered with their health information. The data from the ECG was shared only with participants who then could choose to share with their doctors
A clinical study enabled by digital technology and real world patient-centric data collection is innovative. Peterson and Harrington note: “mSToPS represents a brave new world for clinical research: an innovative, highly commendable, contemporary pragmatic health care IT study that tested an important question and yielded significant clinical findings. Looking forward, the ongoing revolution in data science will likely facilitate future maturation of the pragmatic [randomized clinical trial].”
The approach utilized here is not without its limitations, including partial reliance on “matched” controls, participants’ device use rates, and potential claims data limitations. Peterson and Harrington advise caution along those lines, as do we. That said, the direct-to-participant design may allow expanded and timelier study of digital health technologies as well as diseases with significant lifestyle component or that need to be studied in a real-life environment. Additionally, increased data integration could increase identification and participation of hard-to-find or hard-to-engage patients. While continued refinement is needed, the direct-to-participant design has potential to significantly increase the evidence base, and as consequence, access to new, clinically proven approaches to care.
Effect of a home-based wearable continuous electrocardiographic monitoring patch on detection of undiagnosed atrial fibrillation in individuals at increased risk: The mSToPS randomized clinical trial
Steven R. Steinhubl, MD; JillWaalen, MD, MPH; Alison M. Edwards, MStat; Lauren M. Ariniello, BS; Rajesh R. Mehta, RPh, MS; Gail S. Ebner, BS; Chureen Carter, PharmD, MS; Katie Baca-Motes, MBA; Elise Felicione, MPH, MBA; Troy Sarich, PhD; Eric J. Topol, MD
Author Affiliations: Scripps Translational Science Institute, La Jolla, California (Steinhubl, Waalen, Ariniello, Ebner, Baca-Motes, Topol);Wave Research Center, La Jolla, California (Steinhubl, Ebner, Baca-Motes, Topol); Healthagen Outcomes, Chicago, Illinois (Edwards, Mehta); Janssen Scientific Affairs, Titusville, New Jersey (Carter, Felicione, Sarich).
- Applied Clinical Trials, Sept, 2011
- Forteresearch.com, Oct 2017
- Peterson, E. D., Harrington, R.A. “Evaluating Health Technology Through Pragmatic Trials Novel Approaches to Generate High-Quality Evidence” Journal of the American Medical Association, July 10, 2018 Volume 320, Number p.137-38
- Janssen/BabyCenter.com survey, October 2016
- BabyCenter Clinical Trials Attitudes Survey October 2016