Practices will be recruited and supported by the CRN, costs will be reimbursed and the trial team will provide support. In the internal pilot the AF screening intervention will be delivered entirely centrally and remotely by the trial team.
The trial is a cluster randomised design, where practices will be randomised to either ‘screening’ or ‘control’ in the ratio 1:2. Both screening and control practices would need to perform the initial eligibility search and send invitations / reminders to eligible patients. Once this process is complete, practices will be randomised. Control practices would not undertake any aspect of screening and simply provide outcome data using pre-prepared searches. Participants in screening practices would also be invited by the trial team to take part in the screening programme, the details of which are provided below.
Practices will also be requested to support some of the additional qualitative components listed below.
If you have any questions please get in touch with the trial team.
- Site initiation visit with the local CRN to set the practice up
- Facilitating and enabling researcher observation of the trial set-up and training sessions
- Run a pre-prepared search for eligible patients
- Send an invitation / reminder pack to eligible patients
- Adding a note of consent to the patient record
- Running pre-prepared searches to extract baseline and follow-up data every year for an average of 5 years
- Completing a trial survey
In addition to the activities above the AF screening programme will be delivered remotely (by post) at screening practices. This involves:
- Training on the overall AF screening programme
- Training for GPs in current national anticoagulation therapy guidelines
- Receiving and processing patient screening results, and informing all patients of their result
- Arranging routine clinical GP consultations to discuss anticoagulation therapy for patients diagnosed with AF
Additional activities in some practices:
- Facilitate observations by a researcher of practice general and trial-specific activities and access to trial documentation within the practice (when it is safe to do so at the practice)
- Facilitate researcher observation of GP consultations of SAFER trial patients with a positive or indeterminate screening result (by phone or face to face when safe to do so)
- Allow the research team to approach practice staff members for interview