Pragmatic randomised clinical trials using electronic health records: general practitioner views on a model of a priori consent

Pragmatic randomised clinical trials could use existing electronic health records (EHRs) to identify trial participants, perform randomisation, and to collect follow-up data. Achieving adequate informed consent in routine care and clinician recruitment have been identified as key barriers to this approach to clinical trials. We propose a model where written informed consent for a pragmatic comparative effectiveness trial is obtained in advance by the research team, recorded in the EHR, and then confirmed by the general practitioner (GP) at the time of enrolment. The EHR software then randomly assigns a patient to one of two treatments. Follow-up data is collected in the EHR. Twenty-two of 23 GPs surveyed (96%) were ‘definitely’ or ‘probably’ comfortable with confirming consent. Twenty-one out of 23 GPs (91%) were ‘definitely’ or ‘probably’ comfortable with a patient being randomised to one of two comparable drugs during a routine consultation. Twenty-two out of 23 GPs (96%) were ‘definitely’ or ‘probably’ comfortable with allowing the electronic system to randomise a patient to drug A or drug B and generate a prescription. Ten out of 23 GPs (43%) identified time constraints as the main hurdle to conducting this sort of research in the primary care setting. On average, it was felt that 6.5 min, in addition to a usual consult, would be acceptable to complete enrolment. Our survey found this model of a comparative effectiveness trial to be acceptable to the majority of GPs.