A study conducted by the British Medical Journal (BMJ) investigating a method of retaining potential patients for clinical trials saw a 637% jump in contactable patients within 12 months.
Published in the British Medical Journal of Mental Health, the study implemented a system called the “Count Me In Approach” that sought to drastically increase the amount and diversity of patients available for mental health clinical research.
The study, named “Count Me In: A Novel Approach to Patient Recruitment” used electronic health record (EHR) searches within an unnamed UK National Health Service (NHS) mental health trust to improve recruitment rates as well as improve access to clinical trial opportunities by presenting them with the scheme at their initial clinical appointment.
Clinical staff then documented their research preferences on their electronic health record (EHR) where they would remain contactable unless they chose to opt out of the Count Me In (CMI) programme.
Throughout the study’s 12-month span researchers were able to contact 22,741 patients in the CMI scheme, including 2,716 patients via clinician- and self-referrals and 20,025 via electronic searches. This represented a 637% increase over patients who were contactable via traditional means.
Of those patients, 2,032 (8%) opted out from research through the national data opt-out system and 368 (1%) patients opted out through Count Me In. However, the research also showed that of those who were contacted about specific studies, only 270 consented to participate in relevant trials.
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Commenting on this, the research paper concludes “CMI (vs standard) led to a larger and diverse patient cohort and was favoured by patients and staff. Yet a shift in the NHS research culture is needed to ensure that this diversity translates to actual research participation.”
The study comes following two other studies, one published in the Journal of the Royal Society of Medicine detailing how it takes 17 years on average for health research and innovation to make its way into clinical practice, and another from a US-based contract research organisation, Syneos Health, that found that nearly 80% of clinical trials fail to meet their enrollment timelines.
Another UK NHS Trust in Greater Manchester was able to boost clinical trial participation by 44% between 2017–18 to 2021–22, pushing back against a general UK-wide trend that saw clinical trial participation in the UK drop by 41% every year between 2017 and 2021.
Verena Hinze, co-author of the study, said: “In a world of growing healthcare needs, Count Me In presents a promising solution to tackle the substantial recruitment challenges faced by most clinical trials to expedite the translation of discoveries into clinical practice and provide more equitable access to research. “The next steps for Count Me In will include process improvements to ensure that changing research preferences can easily be modified by both patients and trained staff, cost-effectiveness analyses, and an extension of this approach to other healthcare services across the UK, and internationally.”