Using an electronic tool to screen patients for eligibility for clinical trials

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Clinical investigators are responsible for identifying appropriate participants to participate in research trials. This involves reviewing patients’ information and assessing their suitability for more than one study. For conditions such as stroke, rapid assessment and identification of relevant participants is critical.

Around 3,000 patients are admitted to the stroke/transient ischemic attack (TIA) pathway at Sheffield Teaching Hospitals NHS Foundation Trust each year. The stroke research team aims to screen 100% of those accepted during business hours to assess their suitability to participate in 12 open clinical research studies.

Previously, patient records were manually reviewed against each study’s various inclusion/exclusion criteria. In addition to the time spent physically screening patients, handwritten screening records were also completed, providing audit trail of patients screened and reasons for screening failure. These activities took an average of six minutes per patient, corresponding to six hours of nursing time per week. Additionally, converting the data in these manual logs into useful audit information required significant effort.

challenges

Research staff work a variety of shifts and clinical areas. Access to this information was limited because screening activity was recorded in paper records. This resulted in an inconsistent system for tracking which patients were screened, who was eligible for trials, and whether patients were informed and agreed to participate or refused to participate. This lack of coordination led to inefficiencies in the process.

What did we do?

Our solution was the stroke trial tracker, an electronic tool designed to facilitate the screening and management of patients who may be eligible for research studies. The trial tracker uses existing hospital IT systems to provide relevant patient information and links this to manually added information about the patient’s condition. Using proprietary algorithms, the trial tracker allows automatic and simultaneous screening of patients for eligibility for multiple research studies and coordinated tracking in line with trial protocols.

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

Following an initial discussion to determine what was needed, the tool was further developed using the Plan, Do, Study, Act approach. Liaison with research colleagues before the project was presented to the wider stroke research team ensured that the solution was user-friendly and staff were happy with its functionality. The authors, who had the full support of research staff, received BRC funding to develop the tool together with the trust’s clinical research scientific computing team, which assisted with the technical development of the software.

The iterative design resulted in a real-time platform that automatically screens each stroke patient against inclusion/exclusion criteria for all open recruitment studies. This is accomplished by entering four to five key inclusion variables, combining them with extracted electronic patient demographic data, providing accurate and automated audit trail of patients who are screened, notified, and agree to participate in trials.

The system provides accurate and secure data to members of the stroke research team and allows retrospective screening for future studies. It also maintains accurate audit records of the activities of the stroke research team and patients, which can be searched using built-in database query tools.

Features include:

• All stored data can be searched to create project audits or conduct research;
• Centralized data location – all users access the same precise record, preventing miscommunication;
• Built-in action prompts (for example, telling the patient that they have been informed but have not yet given consent);
• Automatic planning assistant;
• Easily accessible document repository;
• Creating reports;
• Printable confirmation documents.

Results

The introduction of the stroke trial tracker means nurses now spend just one hour a week examining and assessing patients for suitability for research trials. This represents a reduction in screening time of over 80%, freeing up nurses’ time for recruitment activities, which increases patients’ opportunities to participate in clinical trials. The electronic system also reduces human error, increases efficiency, and prevents patients from being approached repeatedly by different team members. Other benefits of the system are:

• Automated patient exclusion saves time so the team can focus on discussing the trial with patients and recruiting;
• Remote access reduces duplication and improves team communication by allowing all team members to view the same definitive record of completed activities;
• Improving research participation activity and reporting of adverse events;
• Improved patient retention throughout the trial and guidance to ensure compliance with trial protocols;
• Patient experience is improved by preventing eligible patients from being missed or contacted multiple times for the same trial.

Staff satisfaction feedback was extremely positive; All team members said they preferred the stroke trial tracker over the old manual system.

future developments

The authors are currently working with the BRC, clinical research, scientific computing and the nursing and clinical research team to extend trial follow-up to other areas at Sheffield Teaching Hospitals, and are also working with commercial partners to enable its adoption and expansion in other NHS sites.

Some aspects of the app are already being used in other areas of the trust. Since the tool is modular, it has the flexibility to work in clinical areas as well as research. As more teams show interest in the 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 the electronic screening system, the BRC core team prepared an evaluation survey that the author sent to stroke centers across the country.

Responses from 50 stroke centers in the UK found that they each accepted 600 to 3,000 patients a year, and 94% of centers were actively screening patients for eligibility for the research study. One-third of these centers estimate they spend three to five hours each week screening stroke patients for research. About 10% did not record their screening activities, but of the 90% who did, about half used paper-based recording and the other half used some form of electronic system, sometimes combined with paper methods. In most cases the electronic system used was an in-house developed Microsoft Excel spreadsheet, which was unlikely to offer the same benefits as the trial tracker. Nearly 80% of respondents said they would be interested in using a different system if it would save time.

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

Solution

Use of the trial tracker electronic system made it easier to screen stroke patients for eligibility for multiple research studies and track them in accordance with trial protocols. The trial tracker reduced screening time by more than 80% and made accurate and secure data available to the entire stroke research team, while providing accurate audit trails. This modular system may have wider application in other clinical and research areas and other NHS organisations.