How does Keele CTU facilitate research feasibility within primary care infrastructures in order to optimise engagement, recruitment and retention?

Problem

Coordinating primary care-related studies on a local and national level presents challenges from engagement, recruitment and conduct, through to retention of both sites and participants. Primary care infrastructure is complex and requires a number of different strategies which are innovative, efficient and transferable in order to successfully coordinate primary care research.

Approach

Keele Clinical Trials Unit (CTU) is a registered CTU, coordinating community based clinical research and trials, taking overall responsibility for the project management of studies in line with appropriate standards and regulations. Our internationally renowned research programme in pain and musculoskeletal disorders in primary care is underpinned by high-quality cohorts, randomised clinical trials and an increasing portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs), all supported by qualitative research. A mixed methods approach is employed to engage, recruit, and retain both practices and participants.

Dedicated project coordination forges strong communication links within the study team, with our dedicated Sponsor/QA office and externally with practices and participants.

It has become increasingly important to develop more formal procedures to identify respective roles, responsibilities and functions provided by a CTU and NIHR Clinical Research Networks (CRNs), early engagement assists study delivery to time and target. A partnership engagement between Keele CTU and NIHR CRN: West Midlands (CRN-WM) has produced ‘Study Interface Responsibilities’, a document to provide a guide to outline the roles and responsibilities at this interface.

Keele CTU works closely with our health informatics team and the CRN-WM for access to GP practices. We employ electronic tools and templates, aide memoires and 'pop ups' which can be embedded within existing GP clinical systems to perform eligibility, identification, recruitment, screening and data collection functions.

A range of innovative retention strategies are utilised by Keele CTU to include; postcard, email, SMS and minimum data collection reminder mailings; newsletters and death and departure auditing.

Findings

Whilst there is variability in CRN resourcing nationally, partnership working improves consistency and engagement in working practices with the primary care infrastructure.

These methods sustain routine care whilst simultaneously screening for research data and participants; provide flexible instruments compatible with all primary care infrastructures; increase clinical precision in identifying suitable participants; automate recording of study data collection; and ensures minimal impact on consultation time. Our retention rates include one month follow-up rates of 93% and 87% response rates to weekly SMS data collection over four months.

Consequences

An increasing number of conditions are now diagnosed and managed within primary care infrastructures, this is therefore where they need to be studied. Research engagement, recruitment and retention targets are achievable, despite encountering problems such as differences in CRN facilitation and primary care infrastructure. Methods described, embedded in primary care, should be utilised more widely to facilitate primary care research.