Efficient trial design and intervention implementation
CMO, Covid infection
The trial was endorsed by Chris Whitty, the then chief medical officer (CMO) for England, as a national priority project and adopted by the CRN as an urgent public health portfolio study. These endorsements facilitated the novel design by allowing access to email addresses of all GP practices via NHS Digital. However, despite extensive piloting of the process by which practices and patients could be contacted, several practical barriers were encountered: (i) some email addresses were ‘inactive’ due to organisational name changes or practice closure, (ii) practices expected to be contacted by CRNs to take part in research projects rather than directly from study teams and (iii) the intervention practice individualised Germ Defence weblink being perceived as spam by staff and patients, particularly where patients had never previously received a text message from their practice). While these concerns were all identified before the trial began (and addressed via the ‘FAQ’ for patients and clinical staff) [Overall, the study team received 61 enquiries/concerns from primary care staff, patients/members of the public and staff within local Clinical Research Networks during and immediately after the 4-month implementation period (Table Reasons for feedback about study intervention or implementationBecause the primary aim of the Germ Defence team was to implement Germ Defence as rapidly and widely as possible (based on the previous evidence of effectiveness), extensive implementation was also undertaken outside the defined trial context. For example, the Germ Defence website and the key messages from Germ Defence were publicised on numerous occasions (via national and local radio, TV, online and print media) and were directly linked to from online government advice for Covid infection control [We encountered no material barriers to importing and linking the trial randomisation schedule into a TRE or to evaluating outcomes using patients’ data in situ through the OpenSAFELY platform rather than via data dissemination.