Case study: Collaboration is Key - A West Midlands Improvement Project

What the project is and its aims

As a Clinical Research Network, University Hospitals Birmingham NHS Foundation Trust (UHB) is our biggest West Midlands Research Site. 

Prior to the start of the project, engagement between the CRN WM and UHB, around who to contact for information required for Performance Monitoring of commercial and non commercial  studies in set up, open and closed was difficult. 

There were issues with completeness of Local Portfolio Management System Data  (EDGE), Research Activity Data and queries. 

Engagement between UHB and the SSS was mostly through face to face meetings between a member of the UHB Research & Development (R&D) Team and the Research Operations Manager (Kirsty Hunter). In addition to this,  the Study Leads within the Study Support Service (SSS) were unsure  of who at UHB they should contact with study queries and likewise how to escalate issues. 

There was a shared  Escalation Spreadsheet in situ, but its use was inconsistent and confusing for both UHB and SSS Study Leads. This had been used for some time and was in need of a review to ensure it was fit for purpose for both parties. 

From a UHB perspective, Amy Smith (Commercial Research Manager) found it difficult to identify the appropriate information and reports to support effective performance management of studies, especially as there were many reports in varying locations.  There was no succinct way of seeing all of the data for studies.

With recent organisational changes at CRN it was timely to review the information available both internally to the CRN and externally to Partner Organisations (POs) to ensure a shared understanding of performance/ delivery.  This led to the setting up of a joint Quality Improvement project  between the Network and the Trust’s R&D team. 

Key Players:

Project Leads:

• Claire Callens - CRN Senior SSS Manager
• Pat Ryan - CRN WM Head of Information Management
• Amy Smith - UHB Commercial Research Manager

Project Collaborators (all CRN WM): 

• Dr Kirsty Hunter - SSS Research Operations Manager & Lead AcoRD Specialist
• Debbie Peplow - Study Support Service Manager
• Natasha Upton - Study Support Service Assistant
• Hamid Hussain - Head of Information Services

Timeline: The project was initiated in May 2022 and finished in December 2022.

How it was carried out

Meetings were held within the CRN WM SSS Quality Improvement Project Team and also  between the CRN WM SSS Quality Improvement Project Team and the UHB R&D  team responsible for performance. 

There were also internal CRN WM Focus Groups supported by other members of the SSS* team and the use of internal surveys. 

What the results/outcomes are:

Various reports/ information shared with individuals based on meeting attendance.

Outcome: Creation of a single location for the various reports, ensuring reports are accessible via the new Performance Support Platform

Provision of a Site Level Operational Report to facilitate a shared understanding of all potential performance indicators, enabling the ‘story to be told’.

Outcomes included: 

- New Recruitment to Time and Target report which incorporated site and national data information such as; recruitment to time and target, first patient first visit, unconfirmed recruitment activity data. It also detailed lead site contact details, aimed at facilitating early identification of studies potentially requiring review/support

- Agreed shared priorities for the use and management of report i.e. studies closing in this Quarter/Financial Year, commercial, non-commercial UHB-sponsored and WM-led.  Initial focus was on studies that hadn’t reported recruitment, were behind target or had recruited to target but were past planned closed dates. This was supported by a Top Tips document

Shared communication and role clarity (new UHB Information and Escalations spreadsheet) including information of who to contact at UHB. The previous UHB Escalations spreadsheet was revisited with signposting added for SSS Leads and instructions for the new UHB escalation process. As the CRN SSS team was also unsure who to contact, UHB shared a Meet the Team document, enabling identification of points of contact.

Outcomes:

• 33% improvement in EDGE Data Compliance between March and November 2022
• 30% improvement in completion of all Research Activity Data Queries in LPMS and a decrease in all data queries  including historical Research Activity Data Queries. UHB is now aware of how to deal with EDGE Data Queries and  liaising with some study teams to sort out outstanding queries
• 40% decrease in meeting time between the CRN Operational Link and UHB Commercial Research Manager 
• 60% decrease in number of queries on UHB Escalation Spreadsheet 

Next steps and dissemination:

For UHB

• Piloting Operational Performance Review meetings with the CRN Industry team, supporting shared priorities, communication and timely actions to be taken
• Consider expanding to non-commercial CRN WM-led studies 
• UHB and CRN WM SSS will continue to update reports as required either via feedback to the CRN WM Industry Team or SSS Team. Both UHB and CRN WM are currently looking at possibly developing a two way communication process for sharing site level study information for Commercial Studies.  The aim would be to minimise duplication of Performance Monitoring activities undertaken by both organisations

For CRN WM

• In 2023 - Launch and showcase of the new Performance Support Platform for access by other NHS POs. Feedback is currently being sought from two other POs
• Showcase new UHB reports to see if other POs would like to adopt this format
• Ensure that UHB and CRN SSS engagement continues by tracking RA data and EDGE compliance and use of the UHB Information and Escalation Spreadsheet
• Promote again the correct use of the UHB Information and Escalation Spreadsheet to the CRN WM SSS especially in terms of adding items on to this, rather than contacting R&D
• Likewise ensuring the SSS Team are using the contact lists provided by UHB in order to contact UHB Study delivery teams directly for correct undertaking of Performance Monitoring activities

Dr Kirsty Hunter (pictured) said: “It has been great working with Amy at UHB to understand from a Trust perspective what their difficulties were in trying to identify the priority areas when there is so much data available on their studies. Working with UHB has been a great starting point for this project as Amy is very knowledgeable on interpreting the data and identifying what could be done better to meet their needs through this quality improvement project. This should pave the way for our other POs to benefit from what has been developed and to identify further improvements to meet the needs of all our POs.”

Amy Smith added: “Working with the CRN team has been extremely helpful in facilitating us to review our portfolio and improve the data accuracy, leading to improved performance overall.  Bringing together the knowledge of the SSS, Informatics Team and Industry/ Senior Team, has enabled cross-portfolio benefits.

“Whilst we can access the Google documents, the creation of the Performance Support Platform in particular has enabled us to more efficiently access key reports and monitor performance, identifying key CRN contacts for each study.

The Site Level Operational Report is invaluable in facilitating effective performance management.  We can quickly review National, Trust and Site level data all in one place.  Identifying quick resolutions, such as data confirmation which can instantly change performance ratings.  This has led to a demonstrable improvement in our performance data and contributing to attracting more studies.”

*Thanks to Nathan Smith - Study Support Service Manager, Debbie Osborne - Study Support Service Facilitator, Natasha Upton - Study Support Assistant, and Ladan Adie - Study Support Service Manager.