Participant consent
arrhythmia, syncope, PIS
EVENTS, EVENT, ARRHYTHMIA, SECONDARY
Potential participants will be given a Participant Information Sheet (PIS). Potential participants will be randomised within 72 hours of their hospital attendance. If a patient has been discharged from the hospital, then they will be contacted by the local clinical team or research team (if part of the clinical team), and a copy of the PIS will be emailed or posted out to the patient. The PIS will also be available on the trial website. A delegated member of the local study team will seek verbal consent over the telephone and will sign the consent form on behalf of the participant. The original consent form will be filed in the Investigator Site File and a copy will be sent to the participant. Alternatively, the patient can attend the hospital with travel expenses, to provide written informed consent in person. The ambulatory ECG device can be sent to the participant’s address or collected from the local study team if randomised to the intervention arm. Each participating centre will upload screening information of non-identifiable potentially eligible patients who were approached to participate in the study, onto the study database. Participants are free to withdraw from the study at any point or can be withdrawn by the investigator.Participants will have an electronic case report form completed at randomisation (Study assessmentseCRF, electronic case report form; ED, emergency department; GP, general practitioner.14-day ambulatory heart monitor (Preventice BodyGuardian Mini).Participants will be required to press the button on the heart monitor after any syncopal event. They will also record symptomatic episodes in a paper diary. The participant will wear the ambulatory ECG monitor for a maximum of 14 days after which they will remove and return it in a prepaid envelope to Preventice UK. The monitor will be reported by a cardiac physiologist, shared with the participant’s local study team, placed in the participant’s health record and shared with the participant’s treating clinician. Treatment of device findings will be at the discretion of the treating clinician at each site. The participant’s general practitioner (GP) will be informed that the participant has been enrolled in the study and will be informed of the results of any ECG investigations via routine hospital clinical correspondence. Participants will be informed of the results of any ECG investigations via routine hospital clinical correspondence. Any study participant with a serious arrhythmia (All participants will be contacted on a 4-weekly basis ±14 days for 2 years via automated text message or email (whichever they prefer) with a link to a brief web-based questionnaire asking for the number of syncope events experienced since their last response and how many of these they attended hospital for. Those who are unable to access digital forms of communication will receive phone calls. They will also be asked since their last response how many times they have visited their GP practice for any reason including all face-to-face, telephone and online consultations. This will import directly into the central ECTU study database. This patient-reported data will be used to inform the primary endpoint. The small number of participants unable to access digital forms of communication and participants not responding for 3 consecutive months will receive a phone call from the central study team (blinded to participant’s study arm allocation) to collect missing data, ensure no syncope episodes have occurred and to encourage continued future engagement. Participants with a mean of 5 or more episodes/month will also receive a phone call from the central study team to ensure that participants are recording true syncope events and are seeking appropriate medical advice.We were very thoughtful about the potential impact of COVID-19 when designing this study including ensuring ambulatory ECG monitors can be sent directly to patients and designing participant follow-up to ensure no additional research related hospital visits are required.Participants will also be contacted at one and 2 years±30 days, by the central study team (blinded to participants study arm allocation) to complete a quality-of-life questionnaire. In the event of non-response, participants will be contacted on up to three occasions. The participants’ involvement in the study will cease at 2 years. Endpoint data including NHS resource usage will be extracted by the local study team from routine hospital electronic healthcare records at 90 days, 1 and 2 years and will be entered into a bespoke database. ECTU will collect and clean primary data and perform primary and secondary analyses.