Important Factors for Implementing a Clinical Trial in Primary Care

Background: Chronic disease management mostly occurs in primary care, underscoring the need to conduct robust clinical trials of prevention strategies in such settings, where people are most likely to benefit. However, there are challenges; therefore we examined lessons learnt from implementing a large randomised controlled trial in primary care, namely the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study. Methods: We analysed the time and resource requirements to systematically implement the CONNECT study in 14 initial practices in order to identify enabling strategies and potential barriers to timely site start-up. Results: Time-critical start-up steps and respective time requirements were the installation of the privacy-compliant shared health record (4-26 weeks) and the identification of the eligible patient cohort (1-4 weeks). Issues that delayed implementation include unanticipated practice-specific issues (such as server upgrades or clinical system incompatibility); unavailability of key decision-making or facilitating staff; and limited access to clinicians’ computers. Enabling strategies that facilitated implementation include (i) strategic recruitment, for example approaching practices with which researchers have existing relationships, (ii) engaging Medicare Locals and Primary Health Networks, (iii) testing technical and other processes in a sentinel practice, (iv) a participant recruitment process with negligible workload for the General Practitioner, and (v) concentrated practice start-up [<10 sites concurrently] to avoid prolonged study staff presence at the practice. Conclusion: We identified numerous important barriers and enablers affecting successful establishment of high quality research trials in the primary care setting. Understanding these factors and incorporating strategies to address them can improve trial planning and implementation.