FAQ + slides: PCORI LHS Pilot Community Office Hours, Nov. 8 – Technology/Registry Development

Q:  How do you handle working with different EMR vendors to make the flow of data work?  Should we include costs involved with that?

A:  We can facilitate the conversation with EHR vendors Epic and Cerner as part of the project.  We use a very structured process to develop data capture so that it fits with clinical workflow.  Central to this process is parsimonious selection of measures, and careful piloting of the system (on paper on a small scale) and then with an eCRF before you integrate new CRFs it into your clinical flow and ultimately with the EHR.  This process is important because it is important to refine the approach with frontline clinicians.  It is very expensive and time-consuming to go back and re-do CRFs once you embed them in the EHR. (See the Data-in-Once Roadmap that describes this 3-4 year process.)

Q:   If the registry is hosted at Cincinnati, can an analyst who is not at Cincinnati log in and use the data? 

A:  This is a data governance issue for a network and is not related to where the data are hosted (ultimately it is likely to be on the cloud anyway).  Most networks allow sites to access and download their own data but require research review before accessing multi-site data.  We will share examples of data sharing agreements, business associates agreements and relevant policies for this work.    Networks could either define a set of users who could download the data (e.g., individuals from each site), or, we could provide some basic tools where they could do their own analyses.

Q:  The paper describing the ImproveCareNow registry mentions i2b2.  Does the new platform involve i2b2?  How do data from the EHR get transferred to the registry platform?

A: The registry used by ImproveCareNow uses i2b2 as a staging layer.  Data entered into web forms or uploaded to the registry are moved from the transactional tables into i2b2.  Data are then pulled from i2b2 and used to generate a series of QI and care management reports.  The new version of the registry platform removes i2b2 from the process to enable more advanced analytics.  If networks were interested in using i2b2, portions of the registry data can be transferred into an i2b2 instance, which would allow networks to use the i2b2 query tool to identify cohorts.

EHR vendors typically have a way to develop data collection forms for a specific topic/condition that can be distributed to all of their customers.  Each customer can install and configure the form in their EHR, which allows for the capture of condition-specific data during the clinic visit.  These data can then be transferred to the registry as a flat file, either uploaded by a user or sent electronically through a secure file transfer process.  The form data are then used in the generation of QI and care management reports.

We rely on clinicians to enter the data in structured ways in the EHR. The reason they will take the time to do that is that they receive back significant clinical benefits at the point of care: PVP, PM, consultation notes, and it is all integrated into their clinical work flow to save time.  It will take your network 12-18 months to integrate it into clinicians’ work flows so that the data is captured. Then the data for research becomes a byproduct.

Q:  LHS Registry Platform vs. our current platform.  Is this literally your platform that we are using, or our platform that we are creating? 

A:  Cincinnati is building a configurable technology/registry platform so that all networks have a tool that is capable of addressing the components of a Learning Health System.  The model is known as an “enhanced registry” by AHRQ.  The registry can be configured on that platform for each network. From there, you could choose to “feed” the registry from the EHR or other data bases, patient reported data, or enter data directly into the registry.

Q:  Do the estimated costs in Year 1 and 2 and beyond represent costs that our network should pay Cincinnati? 

A:   In order to facilitate your thinking as you prepare for your next step towards an LHS, we will be available to consult with you during 1-on-1 calls about alternative approaches.

We want to have a registry solution available so that will provide these benefits that you need if you do not have them already.  If your network already has a registry can meet the functionality of an enhanced registry you can keep using it, but Cincinnati will be unable to provide any support as you work to implement the QI and care management reports within your existing registry.

Depending on the registry approach that you choose, you should budget for about $250 K for configuration costs in Year 1.  Please note that building and maintaining such a registry involves a significant technology cost and to our knowledge there are no existing commercial registry products that have all of these functionalities which means additional costs .  Some networks may have the ability to create their own custom approaches.  If you use a commercial product the costs for configuration will exist as well.    The financial costs of maintaining a registry is why your network’s financial sustainability model is so important.  You will need to be prepared to sustain your annual technology costs, as well as staff support for QI, network operations, etc.

Regarding costs for data team, you may have those staff already, or you can rely on Cincinnati for support.  We can also discuss this during your planning.

Q:   Is there a portion of the overall award from PCORI that is reserved for these technology costs? 

A:  Networks are in different stages of development and will need to determine how best to spend the funds that are available.  As a rule of thumb, a network of 20-30 care centers should be prepared to budget about $300-500 K in the design phase and $750 K per year to run the network, including technology and operational support,  following design.  The technology configuration dollars are likely to be spread across these two years.  We anticipate that it may be weighted towards the first year.

The LHS model envisions engagement of clinical sites that are willing to contribute to the costs of being part of a network. This is what happens on our current networks.  We can coach you on making that value proposition to centers.   There are also other sponsors that may be willing to contribute to the full costs.

Q:   If we have a registry already, what do you recommend that we should highlight in our application?

A:  We recommend looking at the Data & Analytics domain of the Network Maturity Model, and evaluating what you have vs. the idealized capabilities of an advanced system listed there. Think about where you are today vs. where you would like to be in two years and five years.

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