PASS CLINICAL SOFTWARE FOR FAMILIAL HYPERCHOLESTEROLAEMIA (FH) EVALUATION REPORT INCLUDING 3 MONTH CLINICAL PILOT.

Transcription

1 Ms Kate Haralambos (FH Coordinator) C/o Wales Heart Research Institute Cardiff University University Hospital of Wales Cardiff CF14 4XN Tel Background PASS CLINICAL SOFTWARE FOR FAMILIAL HYPERCHOLESTEROLAEMIA (FH) EVALUATION REPORT INCLUDING 3 MONTH CLINICAL PILOT. An FH cascade testing programme requires an IT system to coordinate and manage the process. This has been recognised in the NICE FH clinical guideline. A 3 year cascade testing pilot project in England funded by Dept of Health clearly confirmed the need for such software. As part of that project, new software was commissioned, but it did not function properly and the conclusion was that it was not fit for purpose. The Wales gene park funded a research officer post (Kate Haralambos) to evaluate alternative software approaches to FH cascade testing. This development also received some support from the DOH project. An initial evaluation of the available systems concluded that the most promising software was that used in the Netherlands. It was therefore decided to carry out a more detailed evaluation including a 3 month pilot in clinical practice. The plan was to work with the software company, Pass Software to develop a version of their software Pass Clinical, for use in FH cascade testing in Wales, which would then be potentially extendable to other parts of the UK. The Dutch FH National Screening Programme, StOEH (Stichting Opsporing Erfelijke Hypercholesterolemie) has been using purpose built software for its operation since its inception (approx 7 years ago). This was developed by a commercial company working in conjunction with StOEH. Over the course of the Dutch programme, the software has evolved and improved with 3 major updates. The current system in Netherlands has been used for approx 45,000 individuals of whom approximately 18,000 have a genetically proven diagnosis of FH. The most recent version has incorporated a range of new features and is also available in a multilingual version which means that it is potentially applicable in other countries. In the following screen shots of the database, all patient names are fictitious. Key Features of Pass Clinical The system registers individuals and families with FH. It combines pedigree drawing, data collection and workflow management. The following five key features are described in this report. 1. Pedigree drawing and integrated database 2. Workflow management 3. Template letters and archiving 4. Multi-site working 5. Audit and research 6. Software support

2 1. Pedigree drawing and integrated database The pedigree drawing function is unique to this program and an integral part of the software. It does not use other programs (as was the case in earlier versions), but can import from other programs if needed. The final version is user-friendly and allows pedigrees to be drawn quickly. Initially there were some bugs which made it more cumbersome, but these have been resolved by Pass Software and it is now quick and easy to use, following some basic training. It is fully integrated with the database the database screen can be accessed by opening up an individual from the pedigree. Certain data fields are integrated with the pedigree, for example, if information about lipid lowering treatments is added to the database, a blue quadrant will appear within the individual in the pedigree. In addition, if DNA results are added, these are represented visually on the pedigree by a black dot (mutation positive) or an N (mutation negative). The database is customisable and as shown in the diagram below, there are different tabs which represent different data sets (e.g. demographic data, medical data, lipid data etc). This customisation can only be carried out by the software developers, and not by the user.

3 There is the future potential for the database to connect to other databases such as the Welsh Clinical Portal or the English Spine. 2. Workflow management The relevant specialists involved (FH nurses, genetic counsellors, consultants, laboratory staff) have access to an interface which offers an overview of the tasks that are allocated to them and the tasks of others. The workflow is represented by a sequence of boxes and lists. The boxes are steps in the workflow which are the user s tasks, for example Send result letters. The lists are steps in the workflow which are the co-workers tasks, for example, Genotyping in progress. The user moves the individual through the workflow, from one box to the next as the specific tasks are carried out. This function is very useful as often families are large and one FH nurse may be working on many different families at the same time. It allows the nurse to keep track of what tasks have been carried out and which are outstanding with each family. This however relies on the user to remember to move the patient on in the workflow when each task is carried out.

4 A workflow management program accompanies the database. This allows the database coordinator to alter the workflow (without the assistance of the Pass Software support team). This is something which has proven to be very useful as during the pilot the workflow was constantly fine tuned, and this will continue as the FH cascade testing service evolves. A traffic light system is used which colour codes the individuals within the workflow boxes/lists. If an individual has remained at a particular step for over a specific amount of time (specified by the user), they will be flagged amber or red, depending on how overdue the task is. 3. Template letters and archiving At certain steps in the workflow, there is the option of automatic letter generation. For example, if the user wants to send a direct contact letter, then they select the relevant template and all the details (name, address etc) are automatically entered. All correspondence between the patient and health professionals is digitally archived. 4. Multi-site working Families who are spread out over large geographical areas provide a challenge to health professionals carrying out FH cascade testing. This software allows the coordination of a whole family by several different co-workers in different geographical locations. It allows the transfer of specific individuals in a family to a designated colleague that covers their particular catchment area. This aspect has only been tested to limited extent to date. The system is stored on an NHS server and access to the database is via the NHS network. The different NHS trusts in Wales are connected via an All Wales Digital Network. This allows individuals from different trusts to access the database (via a Citrix server). The data is secure and not held on local computers. Access to the data is password restricted and the extent of access can be securely regulated. Confidentiality and security arrangements have been agreed and monitored by the Cardiff and Vale Trust IT server team and the IT officer for the All Wales Medical Genetic service. 5. Audit and Research Produces an audit trail. Reports can be produced on patient data, for example Genotyping results per year. Management reports can be produced, for example, Number of patients seen per month. In addition, reports can be produced based on clinical trial criteria, allowing the user to search for eligible patients. The reporting function could not be tested during the pilot due to the fact that it was still being developed. However, examples of reports from the Dutch data have been reviewed and look satisfactory. Data can be exported to Excel, SPSS, PDF etc.

5 6. Software support Although the Pass Software is based in The Netherlands, gaining technical support has not been a problem. Support can be accessed via or phone (or Skype at no cost). The quality of the support has been good and any issues or bugs have been resolved quickly. If there are issues which cannot be solved by the support team giving instructions to the user via phone/ , then there is the possibility of remote access to the database. This is where a member of the support team can access the database directly using a program called Netilla. This access is secure and controlled via the IT officer for the All Wales Medical Genetics Service. To adhere to data protection laws, the support team were required to complete a data processor confidentiality agreement. Conclusions The pilot has confirmed an IT system is indispensable for the co-ordination of FH cascade testing. The system was successfully customised to meet local needs by adapting the workflow, the dataset and the pedigree drawing modules. The system has been shown to work in clinical practice. The security and confidentiality aspects are well designed and suitable for use in NHS Wales. The technical software support during development from Pass Clinical was good. It could be extended to other parts of the UK and potentially to other genetic conditions. The software is fit for the purpose of FH Cascade Testing in Wales.