A new approach to recruiting for clinical trials

Dr Verena Hinze writes about her new study looking at the Count Me In approach to recruiting patients for clinical trials. It was published in the British Medical Journal Mental Health, with co-authors Catherine Henshall, Roger Ede and Andrea Cipriani.

Many healthcare systems across the world struggle to deal with growing disease burdens and limited resources to meet the needs of the diverse populations they serve. During the pandemic we saw how rapid patient recruitment to high-quality clinical trials can inform and drive the allocation of limited resources and, as a consequence, accelerate the often quoted 17-year innovation-to-practice gap. Unfortunately, this rapid translation of research into clinical practice remains rare. Nearly 80% of clinical trials fail to recruit patients within their agreed-upon timelines. One explanation for these recruitment challenges is the heavy reliance on clinicians as “gatekeepers”, who may deprioritise patient recruitment amidst other clinical priorities and limited resources, leading to less equitable access to research.

Our study, published in the journal BMJ Mental Health, evaluated a novel researcher-led recruitment approach, known as ‘Count Me In’, in a mental health NHS Trust in England. This approach uses electronic health record searches to improve recruitment rates and ensure equitable access to research opportunities. Specifically, patients (aged 18+) learned about Count Me In at their initial clinical appointment and their research preferences were documented on their electronic health record. Unless they opted out as an active choice, they became contactable for research after 30 days.

Findings

The study found:

• In just 12-months, the number of patients contactable for clinical research increased by 637%, significantly diversifying the cohort of contactable patients. In total, 22,741 patients became contactable through Count Me In, including 2,716 patients via clinician- and self-referrals and 20,025 via electronic searches.
• Of 25,141 patients within relevant services, 2,032 (8%) opted out from research through the national data opt-out and only 368 (1%) patients opted out through Count Me In.
• However, of those identified via electronic searches, only 738 were contacted about specific studies and 270 of them consented to participate, suggesting that Count Me In was only rarely used to recruit patients to open studies.  

Patient and staff experiences with Count Me In identified the following issues:

1. Level of awareness and accessibility: Patient and staff called for greater accessibility of information around Count Me In and wider promotion of related procedures.
2. Perceptions of research and perceived engagement: While research was seen as crucial for improving care, there was a need to explain research opportunities more clearly and manage patient expectations if opportunities were not immediately available. Engagement with Count Me In varied across clinical areas and staff groups, and concerns were raised that some clinicians may no longer feel the need to have research conversations with patients, as this task was viewed as being under the Count Me In remit. 
3. Inclusive research practice: Count Me In was seen as a more inclusive research approach. Nevertheless, concerns were raised that study eligibility criteria and sample size requirements influence and limit the degree to which Count Me In can be utilised.  
4. Engagement and incentives for research participation: Patients and staff expressed the need for ongoing engagement with patients and incentives for research participation, including feeling valued, well-informed, and receiving feedback about their research participation.
5. Relationships between clinical and research settings: Patients and staff members valued this new approach and emphasised the importance of ongoing communication and good working relationships between research teams and clinical services to facilitate continuity. 

The potential to transform research practice

This study demonstrated that Count Me In has the potential to transform research practice by creating a large and diverse patient cohort. Count Me In was favoured by both patients and staff members alike. However, a shift in the research culture of mental health services is needed to influence actual research participation, building on the following pillars:

1. Communication & Training: Investing resources in staff training and patient information to increase awareness and accessibility of Count Me In procedures and give patients confidence in how their data will be used and can benefit research.
2. Partnership: Establishing stronger links between research and clinical services and empowering patients to engage in research.
3. Innovation: Exploring avenues for research innovation, such as novel study designs and use of larger and more diverse patient groups to maximise the benefits of Count Me In.

Implications for the future

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. We need to foster key partnerships with funders and national initiatives, with the aim of transforming patient care and long-term clinical outcomes for patient populations. 

ACKNOWLEDGMENTS

We would like to thank the wider Count Me In authorship team (including Tanya Smith, Jemima Littlejohns, Zoe Collett, Helen Jones, Daniel Maughan, Deborah Moll, Karl Marlowe, Nick Broughton, & John Geddes) and all the patients, clinicians, and NHS staff involved in the Count Me In initiative.