PaTH: Towards a Learning Health System in the Mid-Atlantic Region - Phase I

The PaTH network has all 10 features of an ideal clinical data research network (CDRN) and will expand these capabilities during the project period.

1. Population coverage. More than 2.5 million patients in diverse communities spanning Appalachia to major cities across seven mid-Atlantic states currently receive care and participate in clinical research at our PaTH CDRN sites: All sites use mature electronic medical records (EMRs) with 3 to 25 years of searchable clinical data, and all have active biorepository programs that can be linked with EMR data. Our network includes two larger insurers, which will allow us to track patient visits and outcomes outside the network health systems.
   • University of Pittsburgh/UPMC and UPMC Health Plan (western PA, OH, WV)
   • Penn State College of Medicine/Hershey Medical Center (central PA)
   • Temple University School of Medicine/Temple Health (eastern PA, DE, NJ)
   • Johns Hopkins University/Johns Hopkins Health System and Johns Hopkins Health Care (MD, VA, DC)
2. Data standardization and intraoperability. All PaTH partners currently share EMR data collected with collaborators and national networks, and they will each apply their prior experience to the PCORI program. The CDRN will use an open-source data-sharing tool, i2b2 (Informatics for Integrating Biology and the Beside), to enhance data sharing using international data standards, centrally defined data elements, and the integration of data from any source.
3. Patient contact. Each site can and currently does identify and recruit patients in clinical settings and via online health networks. All sites have expertise in comparative effectiveness research (CER), including many PCORI-funded studies. Each site has years of experience collecting patient-reported outcome measures (PROMs) as part of a routine clinical visit, with some partners doing so as part of their EMR. Each site has experience from scores of clinical studies that confirm, through their publication in medical journals, their ability to meet recruitment goals, minimize patient dropout and missing data, and conduct rigorous follow-up. Each site has community/patient advisory boards and community engagement research cores, and involves clinicians in planning and conducting clinical studies.
4. Patient engagement. PaTH partners use diverse methods for outreach and recruitment: clinic intake questionnaires (some embedded in the EMR), clinical alerts, online personal health records, direct mail (surface and electronic), and social, print and broadcast media. PaTH will specifically identify and engage patients with atrial fibrillation, the most common arrhythmia, affecting ~2.2 million people in the US, which has a myriad of management options; idiopathic pulmonary fibrosis, a rare, chronic, progressive lung disease with an unknown cause and no standard, approved treatment; and obesity, which is at epidemic rates in the US. Throughout this proposal, we use examples from patients with these conditions to describe our network and provide patient-centered context for our vision.
5. System leadership in network governance. Leadership at each site recognize the importance of CER and PROMs in improving the quality and efficiency of care in their health system. Each contributed to the development of PaTH (and remain involved in governance), provided strong letters of support, and will institutionalize network initiatives.
6. National resource. Separately and together, we have the capacity to serve as a national data infrastructure resource as evidenced by the participation of PaTH partner sites in the national research consortium formed by the Clinical and Translational Science Awards and the National Cancer Institute Cancer Biomedical Informatics Grid.
7. Large-scale CER. Each PaTH site currently designs studies, pools and integrates data, and disseminates datasets and tools through their participation in collaborative, large-scale CER as well as pragmatic, cluster-randomized, and observational studies of multiple research questions on a regional and national scale.
8. Embed research activity. PaTH partners, recognizing the critical need to conduct research to improve the quality and efficiency of care, have embedded all aspects of the research process within their clinical workflow. Each site has a clinical workforce for whom integrating research with patient care is second nature and their EMR systems support data collection, abstraction, pooling, and sharing at a system-wide level. PaTH will conduct joint pre-review of Institutional Review Board (IRB) protocols for CDRN projects, followed by rapid approval at each participating site.
9. Data security. Each institution adheres to HIPAA rules for data security, which are divided in to administrative, physical, and technical safeguards. The data center follows not only HIPAA standards but also the Federal Information.
10. Streamlined subcontracting. PaTH will use established subcontracting methods in place at each site and Federal Demonstration Project templates for subawards, which can be easily adapted for use in PCORI projects.