Early diagnosis of patients presenting to Emergency Departments with undiagnosed syncope (blackouts). Signs and Symptoms Syncope and collapse
Conditions
Interventions
Participants will be randomised, 1:1, between the two study arms. Randomisation will be performed using a web-based randomisation service to ensure allocation concealment. The allocation sequence will
Sponsors
The University of Edinburgh and Lothian Health Board ACCORD
Eligibility
Sex/Gender
All
Age
16 Years to 150 Years
Inclusion criteria
Inclusion criteria: 1. Syncope remains unexplained after initial ED/AMU assessment. 2. Aged =16 years 3. Patient has capacity 4. Local resident (i.e. resident within local health board so will not be lost to medical record follow up) 5. Less than five self-reported episodes of syncope in the previous month
Exclusion criteria
Exclusion criteria: 1. Obvious underlying cause after assessment: 1.1. Features of vasovagal syncope AND absence of structural heart disease AND normal physical examination AND normal ECG 1.2. Dysrhythmia on pre-hospital or hospital ECG as likely cause of syncope 1.3. Postural hypotension (symptomatic postural drop >20 mmHg AND suggestive history) 1.4. Confirmed diagnosis of Pulmonary Embolus or Acute Myocardial Infarction 1.5. Radiological diagnosis or clinical signs/symptoms of cerebrovascular accident/transient ischemic attack or subarachnoid haemorrhage 1.6. Evidence of: 1.6.1. Haemorrhage 1.6.2. Alcohol or illicit drugs 1.6.3. Epileptic seizure 1.6.4. Hypoglycemia 1.6.5. Head trauma 1.6.6. Other obvious cause of syncope as presumptive cause of TLoC 2. Inability to consent 3. Previous recruitment into the study 4. Patient in custody or prison 5. Aged <16 years 6. Patient does not reside within local health board and will therefore be lost to medical record follow up 7. Five or more self-reported episodes of syncope in the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of self-reported episodes of syncope at 1 year. Participants will be contacted at monthly intervals throughout the study follow-up which will last for 2 years, by automated text or email (participant preference) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Within trial cost-effectiveness (cost per syncope avoided and cost per quality-adjusted life-year [QALY] gained), and lifetime cost per QALY at (a) 1 year and (b) 2 years measured by NHS resource utilisation data and EQ-5D-5L questionnaires. 2. Number of self-reported episodes of syncope at (a) 90 days and (b) 2 years, those identified in the medical records at (c) 90 days, (d) 1 year and (e) 2 years, and syncope recurrence rate at (f) 90 days, (g) 1 year and (h) 2 years measured from 4 weekly patient brief questionnaire and extraction of NHS resource utilisation data. 3. Index presentation hospital (a) admission rate and (b) duration of hospital stay measured using NHS resource utilisation data at 90 days 1 year and 2 years. 4. Patient satisfaction measured using a patient questionnaire at 1 year 5. Clinically significant cardiac dysrhythmia (serious and/or symptomatic cardiac dysrhythmia at (a) 90 days, (b) 1 year and (c) 2 years measured from NHS resource utilisation data. 6. (a) 30-day, (b) 1-year and (c) 2-year all-cause death as recorded from NHS resource utilisation data 7. Detection of diagnostic ECG/symptom correlation (symptomatic) at (a) 90 days, (b) 1 year and (c) 2 years measured from NHS resource utilisation data and participant self-reported 4 weekly brief questionnaires. 8. Time to detect clinically significant cardiac dysrhythmia (i.e. time to clinician being aware) measured from NHS resource utilisation data at 90 days, 1 year and 2 years. For the intervention group data from the ambulatory ECG monitoring report which will be provided at the end of the 14-day monitoring period. 9. In the intervention group, the duration of enhanced ambulatory ECG monitoring required to detect clinically significant cardiac dysrhythmia measured using data from the ambulatory ECG monitoring report at 90 days 10. Number and type of diagnostic tests and therapeutic interventions at (a) 1 year and (b) 2 years measured from the NHS resource utilisation extraction data | — |
Countries
England, Jersey, Scotland, United Kingdom, Wales
Contacts
Public ContactRachel Locherty
Outcome results
None listed