Using EDGE to manage a complex primary care study

My name is Randeep Basra and I am a Clinical Studies Officer for the Clinical Research Network in North West London. I am part of the delivery team that helps with the setup and support at primary care sites and recruitment of participants for research projects that I am assigned to work on.

One of the projects currently in progress is iHealth-T2D, a multicentre, cluster randomised clinic trial on type 2 diabetes in the South Asian population. The study looks to provide evidence that the implementation of lifestyle modifications and health promotion is clinically effective in reducing the onset of type 2 diabetes in South Asians with central obesity or pre-diabetes compared to usual care. Managing the study has brought on some complex and challenging situations in terms of project management, where communication, organisation and team work has been key to the success we have experienced so far.

This has been helped significantly by the use of EDGE. In the early stages, large amounts of information about the study was kept in a number of places that were not so easy to access and were becoming difficult to manage by the team as a whole. An example of such information was the staff involved and their contact details, information about clinics being run at GP practices and patients recruited, just to name a few. When hearing about EDGE, we felt it could work to solve these issues.

Since then, we haven’t looked back. Once the process of uploading all the information to EDGE had taken place, we found it straightforward to access and the layout easy to navigate. We are able to effortlessly store different pieces of information about the project or primary care sites in one place that everyone can see. For example, I can find a particular recruiting site in a couple of clicks and can access information on how many patients were contacted from a particular site and on what date, when screening clinics are running and how many participants have been recruited so far. The outcome is that everyone is able to look at and maintain up-to-date information about the study from a single place from almost any location at any time.

Knowing that I can add users and have the contact details of any member of staff from any of the 50+ GP practices taking part is reassuring and allows a smooth stream of communication with everyone involved. Personally, the “notes” section is a highlight for me, as being able to communicate updates about an individual site for everyone to see in a free-text box saves time on administration and permits flexibility depending on what information can be stored here. Although it is not necessary to upload patient information to EDGE for our team, I have found using anonymous codes for each patient recruited at GP practices has been a safe and fool-proof way for me to keep an accurate record of how many participants are engaged with the study. Last, but certainly not least, the “project attribute reports” have been wonderful when requiring a snapshot of the study for team meetings and to assess data quality.

This hasn’t just been useful for me the delivery team – other staff who support the delivery team have found it a great way to pull off information from the system when it comes to arranging financial payments or tracking recruitment. In fact, this study was the first we have tried to store financial information on and while this is work in progress, it has been very useful so far. In this way, the whole team can be singing from the same hymn sheet without the need for endless spreadsheets and hard-to-follow email trails.

We would like to give a special thanks to Kaatje and Sean for all the support we have had in making this system work well for the project. We feel the adaptability and brains of the system, as well as the people behind it, are what make it work for us.

Here is a shot of the team who have all been involved in delivering the study.

Post by Randeep Basra, Clinical Studies Officer
CRN North West London
randeep.basra@nihr.ac.uk

Read an article from us

You can find an article from our director James Batchelor in this months International Clinical Trials magazine. The title of the article is 'Strength through Collaboration', where James promotes research teams coordinating both nationally and internationally, in safely changing routine standards of clinical care to improve patient quality of life. 

This piece can be found here and has been taken from International Clinical Trials May 2017, pages 24-26 © Samedan Ltd

Visit the contents page of the current issue of PMPS here

Global Cyber Attack- advice for our users

As you may all be aware, there was a global cyber attack on Friday causing problems across the NHS.

EDGE is hosted at a secure Tier 4 centre at Carelink, one of the highest level of secure centres available. The EDGE service was not impacted by the attack however, as a precaution we decided to temporarily stop access to the EDGE service on Friday evening to allow time for the threat to be better understood and reduce the risk of any impact to the EDGE service. On Saturday morning after further assurances, access to EDGE was resumed.

This was done purely as a precautionary measure.

We would advise that all NHS staff follow the guidance given by their organisation regarding security patches, run windows updates on all machines and continue to keep all computer systems up to date with anti-virus software releases. Further to this we recommend for those trusts who are running Windows XP to contact their IT department to update to Windows 10 as an extra safety precaution.

In general please can all users be extra vigilant when opening emails and do not open any attachments or click on any links if you are not expecting communication from the sender. Malicious emails may appear to come from other NHS employees, so even if you recognise the sender please do not assume that the contents are safe. If you think your computer has been infected by a virus we advise that you immediately disconnect it from the network or shut it down and contact your IT department.

This is also good advice for your personal computers to limit the impact of these cyber attacks.

We will continue to monitor the situation and react appropriately to continue to provide a safe and reliable service.

EDGE's International Accelerate Conference 2017

Firstly, we would like to start with saying a big thank you to all of those who attended our conference on the 29th and 30th March. It is safe to say it was a brilliant two days, in which the EDGE community grew closer together, sharing ideas and best practice.

Thanks to all of our wonderful speakers who shared their EDGE knowledge during numerous breakout sessions and a special thanks to our Canadian friends: Karen Arts, Rebecca Xu and Trina Johnson who gave their international experience with using EDGE. 

We have already received requests for speaker presentations, which will be made available on our website in due course. Along with the video's for each plenary, keynote and breakout session once these have been edited and approved by each speaker. So do keep a look out under our 'News' section for further updates relating to the conference! 

We would like to take this opportunity to share some of the comments we have received regarding our Accelerate conference: 

“The speakers were excellent, I got some brilliant ideas about how to improve local functionality and it was a valuable opportunity to network and improve collaboration with other sites. A very useful conference and I would definitely recommend it!"
Kate May, Research Portfolio Delivery Manager- Brighton & Sussex University Hospitals NHS Trust

“I would like to say a very big thank you and well done from myself and my colleagues at Southend University Hospital NHS Foundation Trust. I have gained a wealth of knowledge from the conference and speaking to such inspiring people as Clare Morgan and Trina Johnson who really empower you to succeed in what you do to improve our services, please pass on my appreciation to them also.”
Siobhan Shearing, Research Midwife- Southend University Hospital NHS Foundation Trust

“It was nice meeting new colleagues and renewing acquaintances with people from the EDGE community. The EDGE team did a fantastic job and a big thank you to them for making me feel so welcome."
Steven Barre, Information Systems Project Manager- NHS Greater Glasgow and Clyde

Keep a look out for updates regarding our next conference in 2018! 

An Improved Research Community in Canada enhanced by EDGE

This post has been written by Rebecca Xu, 3CTN- Canada

Successful clinical trials management for the 3CTN Coordinating Centre (CC) and for 3CTN sites requires a flexible system to track trial-related activities. The system has to work well at two levels: for the CC and the sites. The CC needs to have a system to support the identification and communication of portfolio trials to patients and the public. Also, such a system is important for the evaluation of 3CTN against its milestones and deliverables laid out in its business plan. In addition, to demonstrate an increase in recruitment to academic clinical trials in Canada. 3CTN required each participating site to establish an accurate baseline for recruitment. This is used to continuously evaluate the performance and impact of the Network. A flexible system facilitates this evaluation. Among all Canadian cancer centres responding to the initial 3CTN expression of interest, there was a demand for a clinical trial management system (CTMS) to manage the clinical trial projects, track clinical trial activities, staffing, milestones, metrics and finances centrally and in an organized fashion. The optimal solution to track the metrics and research activities is a common platform for all member sites and the 3CTN Coordinating Centre.

3CTN went looking for a CTMS solution. After consultation with a wide variety and number of stakeholders, and following the recommendation of a working group, based on the positive impact in the UK and first Canadian site (i.e. Juravinski Cancer Centre), the EDGE Clinical Research Management System (EDGE) was selected by 3CTN as the preferred system to roll out at the CC and Canadian cancer centres that expressed interest.

The EDGE system, which was developed in the U.K by the University of Southampton and University Hospitals Southampton National Health Service Foundation Trust, was first introduced in 2001. Since then, EDGE has been used by all the U.K. cancer research networks and several other networks established by the Department of Health in the U.K.  EDGE provides an innovative cloud-based clinical management system that empowers administrators and investigators to make the most of their research data. EDGE is specifically designed to give a real-time view of clinical research activity within a single hospital or across various research networks.
 
The CC formally adopted EDGE in September 2014, with the first goal being the tracking of the portfolio. The CC EDGE hosts a comprehensive listing of all 3CTN-endorsed cancer clinical trials. It allows management of the portfolio, including trial application, and timeline tracking of the review and approval process in a clear, efficient and measurable system. In addition to portfolio tracking, the CC can process all data in EDGE and extract the aggregate and site efficiency metrics with ease. It provides a real time and accurate picture of the high impact academic clinical trials across Canada. The national benchmarking data has also proven to be useful to facilitate ongoing process improvement.

EDGE provides an efficient way to collect and process the data without imposing an excessive burden to 3CTN sites. This common platform limits duplication of data entry and ensures ease of data transfer between 3CTN member sites and the CC. For sites that had already adopted a different CTMS prior to 3CTN, EDGE provides portal capability and flexibility to take-in data from the various systems used by sites.
 
Since the adoption of EDGE by 3CTN, the CC has developed comprehensive implementation supports. These supports include: live demonstrations of the system, project planning, training and first line support to facilitate the roll-out to interested cancer centres. Regional super users were hired to assist with implementation and to ensure sites use EDGE effectively. These super users are situated throughout the Network, and collaborate with the CC to promote best practices, and to determine how EDGE can best be used to benefit all sites across the country.

At the site level, most sites using EDGE are tracking recruitment. Many sites are starting to use EDGE to track regulatory processes and finances for their active recruiting trials, as well as legacy data. The EDGE users are especially pleased with the powerful reporting capabilities of EDGE, which allows them to follow trends in research activities over time. Prior to the implementation of EDGE, sites had numerous files, over a number of file directories to keep track of the progress of trial activation, ethics submissions, contract processes, budgets, and trial metrics (screening and accrual reports).  From a logistics standpoint, having one place to access all clinical trial information is very efficient, and ultimately improves patient care as it enables everyone to use the most up to date documents and information. All members of the patient care team are able to see the progress of a trial from delivery of the protocol to trial activation, and the screening and accrual of patients.  “EDGE provides us with a wealth of knowledge to know which trials are accruing and which are not and why not” states Richard McClelland from London Regional Cancer Centre. Being a network-customized and web-based application, EDGE has led to better communication and collaboration within the cancer clinical trial community, and across the country.

As a result of CC and site level implementation, the EDGE system is helping to improve the conduct of cancer clinical trials across Canada. It enables reliable and real-time measurement of trial metrics and improves the ability of sites and the CC to analyze and use trial data to advantage which should lead to more efficient activity across the Network.

Source of article from: Canadian Cancer Clinical Trial Network 3CTN Pulse Newsletter February 2017 

EDGE Team & CIRU Away day

On the 14th July we headed out to Brockenhurst for our away day to the grand and beautiful Rhinefield House Hotel. Using the hotel’s conference facilities our current team of 23 spent the day learning more about each other, developing team skills and building on working relationships. This was beneficial to all as our unit CIRU (Clinical Informatics Research Unit) keeps on expanding with more staff coming on board. 

The day started with presentations from all the team where we each talked about our individual departments and gave knowledge on topics which everyone at CIRU would benefit from. The Knowledge team talked about the Clinical Trials Process which included how R&D and Pharmacy work which of course relates to our customer base. From the development team we learnt about the development journey from when an idea is first initiated right through to when it becomes live on EDGE. We also got to hear from our team of Associate Software Developers who talked about new products they have been working on such as exciting new apps to help with research and patient visits to hospital. Other topics of the day included customer support and communications within the department including our brand and marketing strategy. We also got the chance to hear results from a recent staff and customer survey which gave us the opportunity to discuss as a team. We were also very lucky to have Professor Topher Woelk present to us, who talked about his work and Bioinformatics.

After all of the presentations and after being fed and watered we began the afternoon activities which certainly tested our team work skills. This included team lego building on things related to CIRU and to EDGE, which meant we got to be kids again (it was great). We also took part in a dressing up video challenge which literally got us laughing out loud at the end result!

I would certainly say the day brought us more together as a team as we discovered more about each other and definitely shared some laughs!