Venous Access National Guideline and Registry Development Coordinated Registry Network
Central venous access is a life-preserving intervention for millions of Americans each year. A considerable proportion of important data in the venous access domain is not captured in the EHR. At least half of venous access care is delivered outside the ICU (where most data is collected) and outside the hospital. Patients and families often feel that their voice is not heard or respected regarding chronic central venous access health care decisions, even though access is often a life-preserving intervention and their complications may be life-ending events. Overall, added costs for all catheter-related complications may exceed tens of billions. With this in mind, MDEpiNet collaborative project has been initiated to develop a patient-facing portal to obtain patientgenerated health data, especially to flag sentinel events, to facilitate patient access to health information for relevant available evidence, and to encourage patient participation and decision making.
The VANGUARD CRN initiative provides a comprehensive, stakeholder-driven environment to define, gather, synthesize, and distribute information related to patients who require chronic central venous access. As a smart think-tank workgroup, VANGUARD was adopted by MDEpiNet in 2015 as one of several related initiatives to develop a national pathway to evaluation of medical device safety and effectiveness. VANGUARD is collaborating with Webshield and MDEpiNet on a Demonstration Project that aims to develop a CRN infrastructure and shared services of value across the CRN COP, focusing on globally selected applied-use cases to focus on ubiquitous problems with solutions that help high-need, high-cost patients. Each Demonstration Project component will share several features: they will demonstrate secure and interoperable exchange of high-value health information, they will be achievable with improved outcomes, decreased costs, and less workflow burden for clinicians and other participants, they will improve data quality in line with federal requirements for sensitive and regulated data, and they will be translatable and scalable across the COP. It is the intent of this project to develop shared services that can be easily adopted by existing CRNs and for other healthcare ecosystem participants.
The goal of the VANGUARD initiative is the development of a prototypical fully-realized coordinated central venous access registry network with broad stakeholder support and participation that is relevant to the clinical, economic and quality of life concerns of the patient populations at risk and responsive to fundamental mandates. It is intended to lower the threshold for fostering innovation; protect health and welfare; provide safe and effective therapy and devices; and reduce the cost of quality healthcare delivery. The mission of the VANGUARD initiative is to leverage multidisciplinary, multi-institutional evidence to improve the quality of care and reduce the costs and complications of care related to central venous access. Therefore, it is developing a national CRN which integrates with other electronic data sources for relevant populations, centered on patient outcomes throughout the venous life cycle, to provide a nexus for collegial action including research, quality assurance, regulation, certification, policy development, guidelines and standards.
VANGUARD CRN is a collaborative MDEpiNet effort initiated by FDA with partners including The Office of the National Coordinator for Health Information Technology (ONC), NLM, NCI Center for Biomedical Informatics & Information Tech, HL-7 Vocabulary Group, AHRQ, catheter manufacturers, health information technology vendors, clinical content experts, and additional potential stakeholder collaborators. The original VANGUARD Advisory Board organized through the MDEpiNet Coordinating Center with Duke Clinical Research Institute has now evolved to a Stakeholder Advisory Panel with logistical support through MDEpiNet leadership at FDA.
VANGUARD has established an MOU with the MDEpiNet Coordinating Center to join the CRN COP.
The patient population includes adult and pediatric patients and often high-need, high-cost patient populations who require chronic central venous access as well as those who require chronic vascular access. These venous access devices include central venous lines, PICCs, Ports and Pumps. The procedures involving central venous access devices fall into five categories: insertion (placement of catheter through a newly established venous access); repair (fixing device without replacement of either catheter or port/pump, other than pharmacologic or mechanical correction of intra-catheter or peri-catheter occlusion); partial replacement of only the catheter component associated with a port/pump device, but not entire device; complete replacement of entire device via same venous access site (complete exchange); and removal of entire device.
Data sources for VANGUARD will include claims and administrative data, as well as registry and other data from various partners. VANGUARD is working with MyLink.com (currently installed in over 25,000 clinics nationally), a service free to patients, to develop partnerships with patient and family organizations like the Oley Foundation (22,000 members concerned with chronic nutritional support) and other similar agencies (e.g., chronic kidney disease patient support), and health IT firms like Cognitive Medical Systems and Mitre Corp. (Patient Toolkit) to enable patients to obtain all their health records and store them in one place, to authorize exchange of their health data with authorized users, to electively participate in research, and to obtain educational materials, guidelines and standards relevant to their healthcare needs.
Current Projects and Plans
Interoperable Coordinated Registry Architecture for Networked Enterprises (iCRANE): iCRANE plans to employ a service-oriented architecture to provide a transparent, platform-independent workflow and registry interface including improved efficiency in patient- and device-tracking and standardization, automated and secure retrieval and distribution of data and images, compliance and tracking for documentation, billing, and communication, and decision support for clinician and patient engagement, as well as for public health and patient safety surveillance, quality improvement, and clinical research.
Semantically interoperable vocabulary: VANGUARD has an approved Project Scope Statement co-sponsored by HL7 Clinical Interoperability Council and the HL7 Clinical Interoperable Modeling Initiative. Interoperable core common data elements have been established. A need for domain-specific interoperable terminology is anticipated by ONC in the US Core Data for Interoperability standard as part of the Cures Act. Employing software from HL7, Mitre and Logica (formerly HSPC), health IT professionals, subject matter experts and other domain-specific stakeholders, core domain-specific clinical data models, FHIR profiles, implementation guides, data dictionaries, SNOMED-CT, LOINC and other standard coding and other documentation will be produced. Targeted terminology will be constrained by necessary and sufficient requirements for planned critical studies. The first phase of this project is targeted for completion by September 2020. Interoperable data elements will also permit automated extraction of other critical events that are captured by the EHR, such as catheter infection and venous thrombosis, with greater validity and precision.
Integrated Medical Management and Educational Gateway (iMMEG): High level EHR “gateway” tool at decision-points of care SOA platform services: The project aims to develop an interactive visual map as an integral CRN component designed as both a source and target for secure interoperable data exchange and data aggregation across patients, devices, systems, and events. It will be integrated with a back-end database and structured reports, decision support and patient engagement systems and with CRN enterprise architecture. As part of continuing care documentation this visual interface will travel with the patient. It will provide an “alert” level source of actionable data for quality, safety, coordination, and research functions wherever the patient may be; from home to healthcare institution to the scene of a disaster. It will serve as a single locus for relevant domain-specific critical clinical events and outcomes.
Pilot registry of venous access: VANGUARD pilot registry project is validating the relationship of central venous structures with visible ‘anchor’ structures such as the spine and the tracheal carina as part of the foundational work in this domain. This allows reliable description of the position of a catheter tip within the venous system. Pilot research is being developed to correlate catheter tip position and complications in high-risk populations, such as ports in oncology patients, hemodialysis catheters in renal failure patients and central access in high-risk pediatric patients.
VANGUARD and UDI: VANGUARD is creating a ripe platform for testing and development of UDI and other EHR tools on compelling implantable medical device problems associated with high volume, high cost and high morbidity events, with rich opportunities for collaboration and convergence on success with other SMART Think Tank initiatives.
Funding: The Society of Interventional Radiologists provided funding for VANGUARD to meet and further refine the pilot and seek additional funding sources.