University Hospitals Birmingham – 06 2021

(View full case study and downloadable version here)

Over the last 3 year’s UHB’s Clinical Trials Pharmacy team have been working towards using EDGE and Power BI in order to provide greater oversight and transparency, help manage workloads and streamline working practice.

KPI Dashboards:
Historically our KPI data was recorded manually on extremely large spreadsheets which took considerable time to complete. Other issues identified were that the spreadsheet was not easily auditable, it could only be opened by one person at a time and it was often being completed in retrospect. We also found a lot of time was spent emailing R&D for answers to queries surrounding data for the spreadsheet and there were also a lot of errors being made due to the large scale of the spreadsheet. We had already started using EDGE for data entry and after a trip to the EDGE conference and seeing EDGE work with Power BI it became clear on what we needed to do to produce presentable data.

We quickly moved from preformatted spreadsheets to using Power BI to perform all calculations using DAX formulas. Now using EDGE data visualised through Power BI KPI data is available to senior staff at the click of a button and is easy to manipulate and identify trigger points that require data collection. As much of the old KPI spreadsheet data was already being populated within EDGE by R&D an entity was created to cover the remaining metric data points for the departmental KPIs. A single report is run now that encompasses all our attributes and those completed by R&D to power many of the dashboards.

Benefits include:

• The majority of data was already entered by R&D so straightway this saved pharmacy staff a great deal of time and effort

• More than one person could enter data at the same time

• Reduced number of fields and the much easier to read format reduced errors to almost zero

• Greatly reduced the amount of time spent sending data queries to R&D

• The data entered was shared with the LCRN via a shared entity further reducing workload of pharmacy staff

• Only one version of the data hence EDGE was always the most up-to-date source of information

Finance dashboards:
Finance was also previously managed using spreadsheet trackers and email communication. Issues were identified such as missing costs, discrepancies as well as in-effective email communication. We decided to build on the information already recorded within our EDGE entities and created a standard costing template for pharmacy related costed activity per CTA. We back dated costed activity, populating the last 5 years’ worth of costs and broke the activity down as per local practice to each individual action. We use the analysis code field to segregate pharmacy costs from those of the wider research team so reporting is far easier and the excel reports are uploaded to Power BI which is made up of several dashboards.  

We process mapped finance as a whole and created a pathway for pharmacy ledgers from the point it is raised and sent to sponsor for review, to the point where pharmacy receive payment. To capture this data, we use a workflow to provide instruction of use and added some additional trigger points from a reporting aspect and then created the dashboards to monitor and manage ledgers generated within pharmacy. When a pharmacy ledger is raised a workflow is added to the study. The reports when pushed into Power BI populate amongst others and a dashboard with a traffic light system acts as a quick and easy focal point to notify pharmacy staff when an invoice needs to be raised. To provide some autonomy without the need to monitor the dashboard an automated invoice alert system was created which automatically generates an email alert to pharmacy staff notifying them that a pharmacy ledger must be raised. The email sends a link to a dashboard with a filtered table of studies that require the invoice along with other pertinent information. This has completely streamlined finance work within the department.

Benefits include:

• Complete up to date financial oversight of accurate pharmacy activity in an easy to read format

• Ability to generate pharmacy invoices and track their progress

• Flexibility in finance workload across the staff, as handovers are now documented within the EDGE workflow and so members of the team can pick up where someone else has left off

• Complete transparency when raising costs to sponsors and for retrospective auditing of costed activity

• Access to financial data across KPI dashboards

• Automated invoice alert system to notify staff when an invoice is due

• Drill down reporting allowing the team to navigate screens for specific data quickly and accurately rather than trawling through emails and other sources.

• The manipulation of costing templates for KPI data collection allows for activity filtering to calculate dispensing KPI’s for commercial studies without the need for additional data entry.

Amendment tracker dashboard:
Most recently R&D have started listing all amendments onto EDGE. We were already trialling amendment workflows to manage amendment workload and measure KPI metrics as this was part of a pilot created by pharmacy EDGE users, as part of the regional CRN led Pharmacy EDGE working group. The old trust system for amendments was a shared spreadsheet tracker upon which R&D staff would enter new amendments submitted to the trust. This would be disseminated at a weekly senior meeting. Now amendments are added to EDGE as a R&D workflow and the report is run to identify new amendments which hit the list. As workflow reports are not easy to read or extract information, we created a simple to read Power BI dashboard that allowed them to quickly view all amendments, identify outstanding amendments and measure KPI metrics. The amendments can be drilled down to view additional information related to the amendment.

The future:
Eventually we would want our data to incorporate non-commercial studies, we would also want our current systems to run from live data rather than scheduled refresh of reports run from EDGE, so there is a lot of work needed here and then we would look at Power Bi apps as the next step. There will be much advancement over the next 12 months and I am really looking forward to being a part of it.

THE LEEDS TEACHING HOSPITALS NHS TRUST - 05/2021

EDGE has been used by the Leeds Teaching Hospitals NHS Trust as its Local Portfolio Management System (LPMS) since 2016, and has become a vital system for managing research and its activity data for clinical trials and other research projects. For example, EDGE has been extremely resourceful for capturing study data and maintaining data quality during the first COVID-19 outbreak in March last year. Our organisation also uses EDGE integrated with Microsoft Power BI allowing more robust use of the system. Below are some examples of how we have used EDGE and Power BI together.

Using EDGE and Power BI has reduced manual reporting. We had 15-20 reports that were run manually on a weekly basis by the Senior Information Manager’s predecessor; all of this is now all automated. The data is refreshed once per day, allowing users to practice self-service and get the latest status on clinical trials.

The NIHR Leeds Clinical Research Facility (LCRF) use a visual calendar which was created using EDGE appointment data at patient level. This has been a useful tool for booking Day 0 and follow up appointments for clinical trials, allowing staff to schedule and manage the facilities efficiently. The LCRF calendar refreshes every 30 minutes.

Additionally, we have recently introduced OneForm, a new system for managing the full study setup process, including Key Support Service approvals (e.g. Radiotherapy, Pharmacy). Capturing data in EDGE and integrating it with the Power BI platform has helped minimise the size of the support service forms, reduce duplication, help streamline the study setup process and identify any blockages that are delaying the opening of the study. This has been useful in the current circumstances as it gives research delivery teams a timeframe for when they will be able to start recruitment. OneForm ensures all the EDGE datasets are completed before submitting requests for support services electronically.

Our next step with EDGE is to integrate with our patient Electronic Health Record (EHR) and link patient records with EDGE research data. This will display an alert on patients’ records to make staff aware if patients are participating in clinical trials, and use key data from EDGE to make staff involved in patient care fully aware of what the trial involves and how to access key data regarding the study. Linking both EDGE and PPM+ will contribute to better patient care and make research more efficient in line with the Leeds Way values (Patient-centred, Fair, Collaborative, Accountable, Empowered). This will also maintain data quality by checking for any inconsistency between data present on both systems.

BARTS HEALTH NHS TRUST - 04/2021

EDGE has been a crucial tool for the running of clinical research within Barts Health NHS Trust. Group Clinical Services division within Barts encompasses a number of departments including Pharmacy, Imaging, Nuclear Medicine, PET, Radiotherapy, Pathology and Therapies, each of which conduct a wide variety of research. The management of these studies requires a powerful tool – one capable of not only processing large amounts of data, but also the ability to present said data in a user-friendly way.

Study Set-up:
Setting up a research study involves a series of steps and input from different departments. With the use of EDGE, this can be fully tracked and managed efficiently. Clinical Physics, for example, would be able to record the dates and progress of their safety testing of any medical devices involved. Imaging would be able to add their Ionising Radiation Medical Exposures Regulation form completion, and Pathology can record its laboratory feasibility forms.

Workflows and study Attributes are key features of EDGE at this stage, providing a breadth of options for customization. The Pharmacy team fully utilizes this by using its range of data entry options (comment boxes, drop downs, tick boxes and procedure guides) to track their trial “Greenlight” process.

Study Delivery:
EDGE also provides a platform at which different divisions, clinicians and any research professionals are able to contribute to the data in EDGE. Within GCS, this allows acquisition manuals, device maintenance documents and Service Level Agreements to be filed for other teams to access where needed.

Research Management:
Additionally, EDGE has brought countless operational benefits by allowing us to simplify 4 processes in particular:

• Financial Administration

• Performance Management

• Capacity Planning

• Study Management

The ability to pull information from EDGE is quick and straightforward, with advanced options where a more customized report is needed. With this, it is possible to see a full breakdown of activities that are generated from studies at a Trust level, minimizing the need for access to individual spread sheets and locally-stored documents. Key study dates, timelines and details of trial staff are also readily available, allowing for studies to be managed closely and efficiently.

Finances can be monitored per study, hospital and even sponsors simply by using the correct filters and reporting tools. The flexibility of these reports mean they can be further narrowed down to different periods of time, and to include or exclude certain key words. This has allowed for a greater visibility of the study performance, and can all be real-time.

Additionally, recruitment numbers can easily be updated easily by the study team, allowing departments to assess their capacity on an on-going basis. This also supports study coordinators with performance management and forecasting. The KPI and Statistics section is a great feature for this task, providing full breakdowns and automatically generated reports for the holistic view of the study’s performance. As with the other EDGE reports, these are also customizable.

Overall, EDGE has brought in many benefits to the trust, including the ability to continue accessing data when the pandemic first hit. Various service improvement ideas are already in the pipeline and will heavily revolve around the use of EDGE.

NRS Cancer Research Network north - 03/2021

EDGE has been used by hospitals in the NHS Research Scotland (NRS) Cancer Research Network for over a decade. It has however been used to varying degrees by the different nodes and sites within these nodes. In the North node EDGE has been used since 2014 to collect recruitment data from the cancer centres. Depending on individual centre requirements EDGE has been personalised to address needs that have arisen at the individual centres.

In 2019 our cancer centre in Inverness at Raigmore Hospital were looking for ways to improve how patient appointments were tracked as an old database needed to be replaced and a better way was needed to capture financial information to pass to R&D for invoicing. This was also a good opportunity to look at other ways EDGE could help the team.

The NRS Cancer Research Network gave the cancer team a detailed training/refresher session on the different aspects of the EDGE system so everyone was up to speed. The main aspects covered were entering patient details, recruitment, recording appointments, using the calendar for annual leave, monitoring visits and for finance input. The trial was supposed to be over 4 months where EDGE and the old database would be used in parallel but within a month it was hard to get staff to keep the old database up to date as everyone was convinced EDGE was the way forward. After 4 months staff opinion was surveyed to gauge how much of an impact EDGE had made.

The outcome was that the whole team were now routinely using EDGE to add patients and their appointments as well as recruitment and the previous database was retired. A calendar is now used to track staff leave and monitor visits. A bespoke costing template is now being used to collect information on what extra tests research patients received which is passed onto R&D to track activity from support departments, this has replaced a complex spreadsheet.

The finance section of EDGE was trialled over the same 4 months to determine if it would collect the financial information required by R&D for invoicing as the research team wanted to try and keep the management of the research within the one system. The Network worked with the research team and R&D to compile all the CTA’s for the active commercial and non-commercial trials onto EDGE and provided training and a short guidance document to the research team and R&D. The research team and R&D evaluated the pilot and it was determined that the finance tools within EDGE were easy to use and contained all the relevant information everyone required. Everyone was very happy to continue using EDGE for finance and an increase in income has been achieved.

We are nearly 2 years after the initial pilot and the team at Raigmore continue to collect finance information using EDGE and finances for all new studies get entered onto the system. The team are also now collecting and tracking patient SAE’s using EDGE and are finding it very intuitive to use. During COVID EDGE has been extremely useful as it can be accessed when home working which would have been difficult using older methods. The team are looking at additional ways they can use EDGE in the future to further improve things for the whole team.

UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST - 2021

UHS use EDGE for remote monitoring which has been extremely useful due to COVID-19. Their R&D department also use EDGE for remote monitoring for the following reasons:

• Specific EDGE monitor access can be created that will only allow the monitor to view document that the account has been created for.

• The monitor account can be created and archived as requested by the site study team with the hospital EDGE administrators, giving our site full control who and when the monitor will access the documents. The accounts can be created under 10 minutes as long the EDGE administrators has all the necessary details.

• It’s access over the internet, therefore the monitor can access the software anywhere.

• UHS has verified the security of the provider and is confident that it holds patient information in line with Trust Data Protection policy and GDPR.

• Enrolled patients have their own dedicate file, therefore it is clear which patient you are accessing.

• There is no limit to the capacity, therefore the document uploaded will be available until the end of the archive period.

• No additional training will be required as this is a read-only account. A short user guide will be given to help with navigation.

• Audit will be carried out as scheduled to have an overview of any accidental changes made by the monitor.

Remote monitoring process:
R&D will review if a study is suitable to have EDGE monitor access. Once this has been approved, the monitor must download a download blocker onto their device and confirm this has actioned with the site study team. This is to give reassurance that the documents cannot be saved on the monitor’s device or appear in their download history. The monitor access user account is validated. For any functions that isn’t necessary to conducting monitoring, UHS have risked assessed and created a mitigation plan for.

When the monitor would like to conduct monitoring, they will contact the site study team to arrange a date and how long the monitoring will be for (i.e. 1 or 2 days). The site study will then send a request to the EDGE administrator with the details of the monitor, monitor email address and the monitoring date. The monitor access will be created the day before the monitoring date, or on the morning if it’s a Monday or the Tuesday after a bank holiday. The account will be close after the monitoring period.  

The benefits:
Using EDGE for remote monitoring has solved a lot of security issues and concerns for UHS as they can safely share patient information within the secure system. Via EDGE UHS are able to scan and upload patient specific notes to the patient record held within EDGE and can control access to the study and control what is seen by the monitor. They know who has access and are able to audit access and what the monitor is doing. EDGE allows the monitors to access the study information and documents at their convenience and it takes up much less site resource.  With not allowing visitors to the hospital site at the moment except in exceptional circumstances, EDGE has provided UHS with an interim solution to remote monitoring which has enabled UHS studies to reopen and for the R&D department to continue research in a safe way, being GCP compliant with data requirements too.

Salisbury NHS Foundation Trust - 2020

EDGE and Covid-19 – The Salisbury NHS Foundation Trust experience.

EDGE has been invaluable as a tool for managing the suspension and restart of our research portfolio and has enabled communication within our team. This article explores how we have used EDGE throughout the first Covid-19 pandemic lockdown.

In March 2020, when the country was first going into lockdown there was a very mixed response from sponsors regarding whether to suspend recruitment to their studies. Some sponsors took the decision to suspend activities, others applied for amendments to conduct activities remotely and some did not modify their protocols at all. As a Trust and a department we had to make decisions about our resources and capacity to support non Urgent Public Health (UPH) studies. We did not want to automatically shut down our complete portfolio as we were unsure whether our staff would be redeployed and some patients with certain conditions were still being seen in the hospital.

EDGE became an important tool in this situation partly because of EDGE’s adaptable nature and in part because of the “EDGE community”. We have long used EDGE to adapt to our needs as a Trust in order to make strategic decisions. EDGE has the ability through the creation of attributes to record and therefore report on a wide variety and depth of information. One of the unsung advantages of EDGE is that you can share your work with the wider community. This meant that when we were looking to work out a strategy for our portfolio, we access the attributes and workflows that other Trusts kindly made public on EDGE. This enabled us to check and consolidate our ideas as well as check that we had not overlooked anything too obvious in our approach. We were able to adapt another Trust’s attributes (shout out to Torbay and South Devon NHS Foundation Trust) to suit our own needs. This meant we had a record of the study being classified (i.e. at what point it would need to be suspended), who made the decision about suspension and any adaptations made to minimise patient risk. Not only did this prove paramount in our planning, having this shared pool of resources promoted the feeling that you were part of a wider community tackling unprecedented issues at a time when it was easy to feel isolated.

During the first lockdown, EDGE made it easier to work from home as we use the system for version control of study documentation. This meant that that staff could access the latest protocols and core study documents remotely and easily through the project site documents section and be assured those were the latest versions.

Finally, lockdown eased and services began to restart. Because we had used EDGE to plan our capacity at the start of lockdown and we regularly use EDGE during the setup of a study (i.e. support department involvement, reward vs difficulty, etc.) we had a vast amount of information that could be relatively easily transformed into an almost ready-made plan of what could be restarted easily, assuming the clinical service was running normally. Restarting has not been easy due to issues surrounding the clinical service and our staffing capacity whilst UPH studies continue but decisions surrounding this could be made much more easily and quickly. We then used a mixture of EDGE workflows, risk assessments and project work instructions to record how the studies would reopen with fluctuating capacity.

We are not out of the woods; we still have capacity issues whilst working hard to support UPH studies. However, using EDGE has made it easier to keep an eye on our research portfolio and the EDGE community has been a great resource and source of support during this time.

United Lincolnshire Hospitals Trust

The Lincolnshire Clinical Research Facility facilitates the implementation and management of clinical research for the United Lincolnshire Hospitals Trust across its multiple hospital sites within the large rural county of Lincolnshire in the East Midlands. The research undertaken within the trust encompasses a wide range of therapeutic areas including oncology, haematology, stroke, cardiology, paediatric, dermatology, diabetes, midwifery, ophthalmology, respiratory, anaesthesia, gastroenterology, renal and orthopaedics. The breadth of research disciplines managed by the research facility and the diversity of hospital sites within the trust called for a flexible clinical trials management system to support its continued growth and build upon operational processes. In April 2016 ULHT implemented EDGE across all of its sites providing a fully-integrated data platform for the benefit of clinicians, research nurses, radiologists, pharmacists and other research professionals, supporting their clinical research and providing real-time trial data and business intelligence.

The nature of research in the region is influenced by the diverse needs of a population and healthcare system in the large rural county of Lincolnshire, and Lincoln as one of the fastest growing cities in the UK. The trust needed a system to provide the flexibility to manage differing scales of operations and the requirements of individual units within its organisation but maximise communication, and provide consistent metrics and reporting. One of EDGE’s greatest qualities is its adaptability which makes it so flexible in managing the complexities of clinical trials and the range of contexts in which they are conducted. 

EDGE is an application which is logical and scalable. During the implementation of the CTMS within the organisation we were able to train and roll out the application around the busy work schedules of the research teams and do this in a stepped process by site. The software is user-friendly yet provides powerful functionality and the option to adapt the application, at multiple levels, to meet the needs of the organisation. A core strength of the system is its flexibility for end-user process adaption, allowing individuals and trusts to creatively develop their particular instance. This in turn contributes to the evolution of EDGE through the perspective of sites and researchers who understand evolving operational needs the most and builds benefits for the EDGE community. The developers have cleverly, through the provision of an attribute based system, created an application which is future-proofed and keeps pace with evolving processes. We can build on the global knowledge of users across the UK and beyond in how we can better use data and systems in the delivery of efficient clinical trials. The role out of the system within our Trust has also provided the unanticipated yet immeasurable benefit of engagement with the wider community of EDGE users in delivering research and in sharing best practices, both in terms of the application itself and sharing research ideas in general. 

Within the United Lincolnshire Hospitals Trust we use EDGE to support the setup, feasibility and approval process for studies, track recruitment, manage patient visits, record resource, interventions and inter-disciplinary departmental involvement such as logging studies requiring ECGs, RECIST criteria, all blood sciences requirements etc. We also use EDGE for substantive reporting and monitoring of metrics by maximising the use of core EDGE reports alongside bespoke attribute reporting at a study level, site level and patient level. We are also seeking to develop the system as a trial evaluation tool and workforce management application. 

EDGE has provided ULHT with an IT platform to support its strategic planning and growth, enhancing its reporting, communication and trial management to support enhanced participant engagement and patient outcomes. All this supports the delivery of efficient clinical trials. The following principles demonstrate the benefit of EDGE for individuals, trusts, networks and the NHS.  

EDGE provides; 

• Complete flexibility to support specific needs of trusts, sites and individuals in managing clinical trials.

• Creative power for trusts and sites to develop their own instances to meet local needs.

• An EDGE community who collaborate to collectively evolve the system.

• A system which is developed through the perspective of the end users who understand their individual needs the most.

• A robust and secure integrated system and data set for enhancing operational delivery at trust, regional and national levels.

• A platform for the NHS and international organisations to strategically develop efficient research operations keeping pace with the evolving clinical research landscape.

The Clatterbridge Cancer Centre NHS Foundation Trust

The Clatterbridge Cancer Centre NHS Foundation Trust (CCC) is pioneering a totally new approach to the care of people with serious illnesses as the UK leader of a national pilot from September 2016 in partnership with Dr Atul Gawande’s Ariadne Labs in Boston, USA and The Marie Curie Palliative Care Institute Liverpool. The Serious Illness Care Programme UK (the Programme) involves meaningful conversations between clinician and patient to identify what matters most to the patient, their goals and their priorities, as they look ahead to treatment and care. The conversations are carefully structured and documented, making sure they take place at the right time and in the right place for each patient.

Our aim is to put data capture systems in place to ensure that the implementation of the Programme can be measured and evaluated accurately whilst ensuring patient safety.

NHS England provided funding for CCC to implement the Programme across three very different sites in the UK, at CCC and primary care GP practices across Airedale in Yorkshire and Southend in Essex.  It was essential that there was robust infrastructure in place to provide not only good governance and oversight but also accurate reporting on agreed outcome metrics. We needed to map activity and progress as part of the monitoring and evaluation process for stakeholders.  As we only had a year for implementation and reporting, it was essential that an easy to use, electronic system that was flexible, allowed anonymisation of participants, was access protected, auditable and quick to build and test, that was accessible for the Data Managers across the disparate sites.  We set our user specific requirements and it was obvious that Edge provided the solution.

The solution that we chose was to expand the use of our Edge platform.  CCC was one of the first Trusts to use Edge for recruitment reporting.  We expanded our use of Edge as a filestore for our studies and used the project attributes and workflows bespoke to our needs as our main governance system, both as Participating Site and Sponsor. Therefore Edge was the natural choice for our Programme infrastructure.  We used the patients tab (and patient flows) to flex for our requirements.  The tabs already set up were perfect for adding the alphanumeric patient codes (letters to ID the site, numbers as a patient count); this was completed by site Data Managers so the Programme staff could never identify the patients receiving the conversation.  We could add the ‘patient screened’ date tab to record the date the patient was reviewed at site as potential beneficiary of the conversation.

We could then begin building in the attributes in order to enter the data needed for our outcome reports and analysis. Attributes were built to map the patient demographics, and coded for the Programme so that it was simple to pull data when setting up queries for reporting. We then built a other sets of attributes to report on the actual activity; the GPs and Clinicians who had the conversations with the patients and the record of such within Edge. Once the attributes were built, we used the Edge infrastructure for our reporting requirements. 

Once in the patient tab we could see the patient code, by clicking on ‘anonymous’ rather than name (as the information was anonymised to the Implementation Team)  we could select the attributes tab, then the usual ‘add entities’.  Our three reporting entities could then be added, namely: Anonymised demographics, Patient screening and evaluation record and the Patient evaluation report. This enabled the following critical outputs to easily be determined:

• Date patient screened

• Patient deemed as appropriate to benefit from the Programme

• Date patient approached

• Date patient and Clinician had the Programme conversation

• Number of initial conversations taking place per patients per Clinician per Site

• Number of follow-up conversations taking place per patient per Clinician per Site

• Number of conversations per patient screened per site

• Entry of information into the Practice/ Hospital electronic medical records

• Number of patients consented to take part in the Patient evaluation per Clinician per Site

• Uptake of the survey by the patients

• Evaluation of the Patient Experience

We could monitor and evaluate progress in real time to determine both individual clinician uptake, activity and that of the site in total and the number of conversations that patients had, either as raw data or as per those at site or drilled down to each clinician at site.  This could allow the Implementation Team to provide coaching and support tailored to each site need.   

The implementation of the Serious Illness Care Programme has been a novel and exciting service for patient benefit.  The crucial infrastructure provided by the flexible and auditable Edge system has enhanced and enabled critical analysis, monitoring and evaluation of the Programme, providing essential information on the implementation for improvement and sustainability.