The proposed Accelerating Data Value Across a National Community Health Center Network (ADVANCE) clinical data research network (CDRN) will be led by the OCHIN Community Health Information Network in partnership with Health Choice Network and Fenway Health. Together, we have outpatient clinical data from 97 federally-qualified health center (FQHC) health systems with 744 clinics serving safety net patients, many of whom are uninsured or publicly insured (a population often underrepresented in research). The ADVANCE CDRN will greatly accelerate our efforts to build a “community laboratory” of FQHCs in which to conduct patient-centered outcomes research (PCOR). We currently have electronic longitudinal outpatient clinical data on >1.6 million patients seen in the past 2 years (7/1/2011 — 6/30/2013) and a cumulative total of nearly 4.5 million patients ever seen within these systems. We will add inpatient data to this repository by strategically partnering with health plans and hospitals caring for the same patients; we will also add community-level and patient-reported data for these FQHC patient populations. Our community-based CDRN will have significant stakeholder engagement and a nimble yet robust infrastructure, and will offer unique opportunities for those wishing to partner with us. We have a demonstrated ability to participate in such collaborations, and the ADVANCE CRDN will greatly expand our ability to do so. Our primary aims are to:
- Integrate outpatient, hospital, and community-level data into a single data management system;
- Expand our efforts to engage patients and clinicians who contribute to the design, implementation, and interpretation of comparative effectiveness research;
- Develop electronic systems for recruiting study participants and collecting patient-reported data;
- Strengthen the infrastructure of our community-academic partnerships to support PCOR, and support FQHCs to become learning health systems; and
- Build the capacity of our FQHC networks to meet research regulatory requirements.
Project Pillars: The ADVANCE CDRN's three project "pillars" will provide the core infrastructure and expertise for accomplishing these aims. The pillars will be operationalized by workgroups of patient investigators, community investigators, and academic investigators collaborating to meet project goals.
- Data Pillar: This team will normalize, validate, and expand our clinical data repository. We have an integrated "horizontal" database of outpatient data from FQHC patients in 22 states, into which we will "vertically" integrate data from hospitals and health plans that serve the same patients in this population. We will also incorporate neighborhood-level data from the communities in which these patients live.
- Cohort Pillar: This team will engage and recruit patient participants for three cohorts. (1) Common Disease Cohort: we have 91,668 adult patients in our CDRN population with diabetes. (2) Rare Disease Cohort: we have 2,617 adult patients co-infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) in our CDRN patient population. (3) Obesity Cohort: we have >264,000 obese adult patients (body mass index > 30), of whom 21% have been diagnosed with diabetes, and another 7% have prediabetes or metabolic syndrome.
- Regulatory Pillar: Building on OCHIN's existing policies, and working closely with our compliance officer and data stewardship committee, this workgroup will streamline our existing policies for data security, privacy and confidentiality, identify one central Institutional Review Board (IRB) for our CDRN, and ensure that all partners have a Federalwide Assurance (FWA) that designates oversight to that IRB.
The Data, Cohort, and Regulatory Pillar workgroups will coordinate efforts with oversight by the ADVANCE advisory council. Each workgroup will dedicate members to liaise with the national coordinating center to ensure that our CDRN activities are well coordinated and synergistic with national efforts, and that the national network of CDRNs is able to include vulnerable and diverse FQHC patient populations in PCOR.