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Introduction: Stroke is a major public health problem, and stroke-related research is crucial. However, enrollment in randomized controlled stroke trials of acute therapies is challenging, leading to missed patients during the screening phase. The current screening process is person-dependent and can be highly variable across stroke team members, time of the day, and hospitals. High-volume stroke centers participate in more than 15 simultaneous NIH and industry-sponsored stroke trials. We hypothesize that a HIPAA-compliant screening tool can optimize screening and increase trial enrollment. Methods: This tool is a HIPAA-compliant application, developed by the Power Team at the University of Pittsburgh Medical Center, using Microsoft Power Apps. It has three purposes: screening, maintaining the database, and reporting. The screening process begins with patient demographics, and basic stroke-related data, followed by acute ischemic, subacute ischemic, and hemorrhagic stroke trial groups. Users can select their preferred subgroup of studies and continue filling in the rest of the form by answering pertinent questions. Upon form submission, the tool calculates the patient’s eligibility status for each trial in that group. The database is immediately available on the opening page or on the cloud. After submission, this can be edited, e.g., refusal for enrollment, or change in the patient’s condition. Reporting can be automated by using Power tools or it can be done manually. For manual reporting, the database gives filtering options based on time frames, patients, trials, and more. Results: The tool is in the testing phase, and we expect to have enrollment data by the time of the meeting. Conclusions: This tool has several advantages over manual screening. First, it reduces the orientation time for new research team members. Second, it mitigates the risk of overlooking potentially eligible patients in time-sensitive scenarios. Third, it is highly customizable by editing the codebook and can be adjusted per research site. This can be particularly helpful for smaller hospitals surrounded by underserved areas and can decrease health disparities by extending the chance of clinical trial participation. Fourth, it automatically maintains an up-to-date data log, which can be extracted at various intervals, such as monthly or per study. This not only streamlines the data recording but also simplifies reporting to study sponsors. Lastly, it expedites trial completion by accelerating the enrollment process. In conclusion, this tool can have significant benefits for research teams and for the broader public.
Sari et al. (Tue,) studied this question.