Project Summary
Fifteen years ago, we began our quest to develop informatics infrastructure and regulatory innovation that would convert the emerging electronic health record (EHR) into a research tool that could improve patient outcomes. First, we built Indivo, the first personally controlled health record, which gave patients their data, and apps to make that data useful. Then, i2b2 (Informatics for Integrating Biology and the Bedside) built an open source "sidecar" to the EHR to fuse and analyze data produced by the delivery system and to identify research cohorts. The i2b2 flexible common data model readily accommodates all data types. Our next advance was SHRINE (Shared Health Research Information Network), a tool enabling investigators to query i2b2 sidecars across multiple sites simultaneously. i2b2-SHRINE has been successfully implemented at more than 100 sites across the US, thereby enabling investigators to use delivery system data to identify patients with specific illnesses and clinical characteristics. At least three other CDRN applications are using i2b2 and SHRINE, attesting to their value and dissemination. Finally, we built SMART, a platform to enable any developer to contribute to an "App Store for Health and Research" compatible with i2b2-SHRINE instances or compliant EHR. Although these informatics tools and regulatory advances have had the potential to be transformative, they have yet to substantially impact the health of our patients and those at risk.
Until PCORI presented its focused challenge to the nation, we did not have sufficient vision or resources to address the critical collaborative patient-oriented questions that are necessary to improve human health. Nor had we fully partnered with our patients to define and continuously refine the nature of these questions and their outcomes. The opportunity to design a clinical data research network (CDRN) provided this vision, but also catalyzed our interest, resolve, and commitment to focus our effort and resources on the objectives of PCORI. If funded, within 18 months we will enable and share our informatics tools and join with the geographically and ethnically diverse PCORI network to partner with our patients and address the most important questions in pulmonary arterial hypertension, osteoarthritis, and obesity. We will build, test, and deliver our Scalable Collaborative Infrastructure for a Learning Health System (SCILHS), which leverages the $48 billion of federal investment in health IT to enable a common data model across 10 health systems, covering more than 8 million patients, plugging universally into the point of care, generating evidence and discovery, and thereby enabling clinician and patient participation in research during the patient encounter. Central to the success of SCILHS is the development of innovative apps to improve patient-centered outcomes research (PCOR) methods and capacitate point-of-care functions such as consent, enrollment, randomization, and outreach for patient-reported outcomes. SCILHS adapts and extends an existing national research network formed on an advanced IT infrastructure built with open source, free, modular components.
To achieve our goals and meet the metrics within this 18-month timeline, we have assembled a team of clinical and patient stakeholders, internationally recognized medical computing and informatics experts, and leaders in the fields of PCOR, patient engagement, and regulatory innovation. Our governance model includes patients, clinicians, health plan stakeholders, and illness-specific investigators who will ensure that we meet our goals and milestones. SCILHS will GENERATE research agendas, APPROVE studies, IDENTIFY participants from diverse populations, INFORM them about research, ENROLL them in trials, ENGAGE them, along with their families and providers, STUDY the cohort with ongoing bidirectional communication, and RETURN research results.
Phase I addresses arthritis, pulmonary arterial hypertension and obesity, in pediatric and adult patients, at 10 diverse sites, including the major hospitals in Boston. We foster a virtuous cycle where shared information drives improved care and returns knowledge to participants, sustaining engagement and enabling all healthcare stakeholders to LEARN from every healthcare encounter. SCILHS brings to PCORI the ability to leverage the federally mandated protocol (we lead with the White House design of "Blue Button" for data exchange among EHRs and patients) to promote data liquidity by interchanging data within SCILHS and sharing it with other CDRNs and patient-powered research networks (PPRNs) (10 PPRNs partner with us) as well as with NIH Clinical and Translational Science Awards and Research Centers in Minority Institutions. We will deliver to PCORI, the CDRN network, and the nation, the backbone for a Learning Healthcare System. Most importantly, SCILHS will ensure that the patient voice is heard and listened to, and that our patients are our full partners in developing our studies, interpreting their outcomes, and prioritizing their impact on the health of the nation.