Count Me In: an inclusive approach towards patient recruitment for clinical research studies in the NHS

Abstract

Background: Participation in clinical research is associated with better patient outcomes and higher staff retention and satisfaction rates. Nevertheless, patient recruitment to mental health studies is challenging due to a reliance on clinician or patient referrals (standard approach). To empower patients and make healthcare research more equitable, we explored a novel researcher-led approach, called 'Count Me In' (CMI).

Objective: To evaluate a 12-month implementation of CMI in a routine clinical setting.

Methods: CMI was launched in August 2021 in a mental health National Health Service (NHS) Trust in England. Patients (aged 18+) learnt about CMI at their initial clinical appointment. Unless they opted out, they became contactable for research (via research informatics searches).

Findings: After 12 months, 368 patients opted out and 22 741 became contactable through CMI, including 2716 through the standard approach and 20 025 through electronic searches (637% increase). Of those identified via electronic searches, 738 were contacted about specific studies and 270 consented to participate. Five themes were identified based on patient and staff experiences of CMI: 'level of awareness and accessibility of CMI', 'perceptions of research and perceived engagement with CMI', 'inclusive research practice', 'engagement and incentives for research participation', and 'relationships between clinical and research settings'.

Conclusions: 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.

Clinical implications: Through collaboration with other NHS Trusts and services, key funders (National Institute for Health and Care Research) and new national initiatives (Office for Life Sciences Mental Health Mission), CMI has the potential to address recruitment challenges through rapid patient recruitment into time-sensitive country-wide studies.

Keywords: Adult psychiatry.

Figure 1

Patients recruited to clinical research studies over time by study type and status, based on Siteline historical data. The black line reveals the observed total across time, while the dashed line shows the predicted total across time. Study types: ‘clinical investigation or other study of a medical device’ (medical device), ‘clinical trial of an investigational medicinal product’ (medicinal product), ‘other clinical trial to study a novel intervention or a randomised clinical trial to compare interventions in clinical practice’ (intervention), ‘basic science study involving procedures with human participants’ (basic science), ‘study administering questionnaires/interviews for quantitative analysis or using mixed quantitative/qualitative data’ (observational), ‘study involving qualitative methods only’ (qualitative), ‘study limited to working with human tissue samples (or other human biological samples) and data (specific project only)’ (tissue), ‘research database’ (database), and ‘other study’ (other).

Figure 2

Accumulative number of patients in the Count Me In cohort over time. The sum of all parts reveals the accumulative number of patients in the participating Trust’s case load by month. The sum of the bottom two parts reveals the total Count Me In cohort of patients contactable for research via the standard recruitment approach or through the research informatics searches.

Figure 3

Flow diagram: participants recruited through CMI RI searches. CMI, Count Me In; RI, research informatics.