The VANGUARD initiative has been developed to provide a comprehensive, stakeholder-driven environment to define, gather, synthesize and distribute information related to patients who require chronic central venous access. As a SMART Thinktank 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.
With the advent of the National Evaluation System for Medical Technology (NEST), VANGUARD is working within the MDEpiNet community to capture the developmental experience as a prototypical strategic coordinated registry network (CRN). VANGUARD is collaborating with other CRNs to create a “best practices” and FAQ guide for entities embarking on this journey to lower the threshold for success. Most recently, VANGUARD is joining with other developing registries to form a common registry framework working group under the leaderhip of the Duke Clinical Research Institute. It is the aim of these initiatives to increase and broaden the flow of quality evidence about medical device safety and effectiveness.
Interoperable representation of relevant elements and events is essential to automated extraction of valid data about device deployment, use and outcomes. VANGUARD is completing a Project Scope Statement for the HL7 Clinical Interoperable Modeling Initiative (CIMI) to develop clinical data models, FHIR profiles and implementation guides for the central venous domain. We have a multidisciplinary subject matter expert group and a multi-stakeholder advisory group, diverse both across pertinent medical societies and across government agencies, healthcare facilities, payers, catheter manufacturers and patients, lead by VANGUARD and CIMI facilitators. The first phase of this project is targeted for completion by January 2019.
VANGUARD continues to work on structured reporting in the central venous access domain. Structured reports have been implemented in the interventional radiology community, with ongoing efforts to extend these reports to other reporting systems for use by surgeons, nephrologists, nurses and other involved practitioners. 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.
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 (where very little data is collected). Patients and families note that their voice is quite muted in the care of patients who require chronic central venous access, where access is often a life-preserving intervention. Of the 8 million central venous catheters inserted in the US each year, approximately 1.7-3 million are for chronic central venous access. The added costs of associated complications in this group exceed $1.8-10.9 billion.
VANGUARD has initiated a collaborative project to develop a patient-facing portal to obtain patient generated health data, especially to flag sentinel events, to facilitate patient access to health information in the context of relevant available evidence, and to encourage greater participation in and responsibility for decisions about their health management. Integration of the unique device identifier (UDI) and auxiliary device characteristics will help to link the patient to their device and outcomes over time and across venues. Collaboration across the MDEpiNet SMART Thinktank Workgroups (VANGUARD, RAPID and BUILD), with MITRE/CAMH and other commercial interests will facilitate solution of common process and infrastructure needs.
The VANGUARD CRN continues to work on related clinical research initiatives. As part of the foundational work in this domain, a VANGUARD project is validating the relationship of central venous structures (which cannot be seen on plain radiographs) with visible ‘anchor’ structures such as the spine (an internal ruler that grows with the patient) and the tracheal carina (a ‘zero point reference’ on the ruler). This allows reliable description of the position of a catheter tip within the venous system. Pilot research is being developed in parallel to correlate 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. These pilot projects operationalize the building blocks described above, extracting meaningful real world evidence on devices and outcomes from workflow across the device life-cycle and across time and venues that is relevant to the actual needs of patients.
Contact: Kevin M. Baskin, MD
VANGUARD Principal Investigator
Funding: The Society of Interventional Radiologists provided funding for VANGUARD to meet and further refine the pilot and seek additional funding sources.