Introduction

Clinical researchers are responsible for identifying appropriate participants to participate in research trials. This involves reviewing patient information and assessing their eligibility for multiple trials. For conditions such as stroke, rapid assessment and identification of affected participants is essential.

At Sheffield Teaching Hospitals NHS Foundation Trust, approximately 3,000 patients are admitted to the stroke/transient ischemic attack (TIA) pathway each year. The Stroke Research Team aims to screen 100% of those admitted during office hours to assess their eligibility to participate in 12 open-label clinical research studies.

Previously, patient records were manually reviewed against the different inclusion/exclusion criteria for each study. In addition to time spent physically examining patients, handwritten screening logs were completed, providing an audit trail of patients screened and reasons for screen failure. These activities took an average of six minutes per patient, which represents six hours of nursing care per week. Additionally, compiling data from these manual logs into useful audit information required considerable effort.

Challenges

Research staff work in different shifts and clinical areas. Since control activities were recorded in paper logs, access to this information was limited. This resulted in an inconsistent system for knowing which patients had been screened, who were eligible for trials, and whether patients had been informed and consented or declined to participate. This lack of coordination led to inefficiencies in the process.

What we did

Our solution was the Stroke Trial Tracking System, an electronic tool designed to streamline the screening and management of patients who may be eligible for research studies. The Trial Tracking System uses existing hospital IT systems to provide relevant patient information and links it to manually added information relevant to the patient’s condition. Using tailored algorithms, Trial Tracker enables automated, simultaneous screening of patients for suitability for multiple research studies and coordinated monitoring in accordance with trial protocols.

The initiative was led by nurses. The lead author identified an unmet need for an electronic screening management tool and obtained approval from the National Institute for Health and Care Research (NIHR) Sheffield Biomedical Research Center (BRC). She then led the planning, development and evaluation of the tool to ensure that all elements of the design and implementation were complete and demonstrated effectiveness.

After an initial discussion to identify what was needed, the tool was developed further using a Plan, Do, Study, Act approach. Liaison with research colleagues ensured the solution was user-friendly and staff were happy with its functionality before the project was presented to the wider stroke research team. Having gained the full support of research staff, the authors secured funding from the BRC to develop the tool with the trust’s Clinical Research Scientific Computing team who contributed to the technical development of the software.

The iterative design resulted in a real-time platform, which automatically screens each stroke patient against inclusion/exclusion criteria for all open-enrollment studies. This is achieved by capturing four to five key inclusion variables, merged with electronic demographic data extracted from patients, providing an accurate and automatic audit trail of patients who were screened, received information and who consented to participate to the tests.

The system provides accurate and secure data to members of the stroke research team and enables retrospective screening for future studies. It also maintains accurate audit trails of stroke research team and patient activity, which can be searched through the use of built-in database query tools.

Features include:

• All stored data can be searched to generate project audits or for research purposes;
• Central data location – all users access the same final record, avoiding communication issues;
• Built-in action alerts (e.g., indicating that the patient has received information but has not yet consented);
• Automatic Scheduling Assistant;
• Easily accessible document repository;
• Report generation;
• Printable consent document.

Results

The introduction of the Stroke Trial Tracking System means nurses now spend just one hour a week examining and assessing patients to determine their eligibility for research trials. This represents a reduction of more than 80% in screening time, freeing up nurse time for recruitment activities, increasing opportunities for patients to become involved in clinical trials. The electronic system also reduces human error, improves efficiency and prevents patients from being approached multiple times by different team members. Other benefits of the system include:

• Automated patient exclusion saves time and allows the team to focus on research discussions with patients and recruitment;
• Remote access allows all team members to view the same final record showing completed activities, reducing duplication and improving team communications;
• Improved reporting of study recruitment activities and adverse events;
• Improved patient retention throughout the trial and calls for ensuring compliance with trial protocols;
• Improved patient experience, either by avoiding eligible patients being missed or approached multiple times for the same trial.

Feedback on staff satisfaction has been overwhelmingly positive, with all team members saying they preferred the stroke trial tracking system to the old manual system.

Future developments

The authors are now working with the BRC, Clinical Research Scientific Computing and the Nursing and Clinical Research team to extend trial monitoring to other areas of Sheffield University Hospitals, as well as engaging with partners commercial to enable its adoption and expansion into other NHS facilities.

Some aspects of the app are already used in other areas of the trust. Since the tool is modular, it has the flexibility to work in clinical areas as well as in research. With more teams expressing interest in this tool, we have successfully applied it to dementia and aim to apply it to other areas of research.

To determine the national need and transferability of an electronic screening system, the BRC core team produced an assessment questionnaire that the author sent to stroke centers nationwide.

Responses from 50 UK stroke centers revealed that each admits between 600 and 3,000 patients per year, with 94% of centers actively screening patients for eligibility for research studies. A third of these centers estimate they spend three to five hours each week screening stroke patients for research purposes. About 10% did not record their testing activity, but of the 90% who did, about half used paper recording and the other half used some sort of electronic system, sometimes in combination with paper methods. In many cases the electronic system used was an in-house developed Microsoft Excel spreadsheet, which is unlikely to provide the same benefits as the trial tracking system. About 80% of participants said they would be interested in using a different system if it saved them time.

Following this research, the authors are working with the trust’s Office of Clinical Research and Innovation and the Medipex Healthcare Innovation Hub to explore distribution opportunities outside the trust.

Conclusion

The use of the electronic trial tracking system has streamlined the screening of stroke patients to determine their eligibility for multiple research studies and their follow-up according to trial protocols. Trial tracking system has reduced screening time by more than 80% and makes accurate, secure data available to the entire stroke research team while providing accurate audit trails . This modular system could have wider application in other clinical and research areas and other NHS organisations.