Chest pain Circulatory System Chest pain, unspecified
Conditions
Interventions
After written consent has been obtained, participants will be randomised to be evaluated using either the existing rule-out strategy used in study centres (control) or the LoDED strategy (intervention
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Presenting to ED with chest pain and triggering the chest pain investigation pathway i.e. treating clinician intends to perform investigation to rule out a cardiac cause 3. Peak symptoms occurred <6 hours prior to presentation to the ED
Exclusion criteria
Exclusion criteria: 1. ST-elevation myocardial infarction or ischaemic ECG (new T wave inversion > 3mm or ST depression > 1mm) as judged by the treating clinician 2. Clear non-ACS cause for chest pain found at presentation (e.g. pulmonary embolism, pneumonia, aortic dissection) 3. Initial hs-troponin result known to the treating clinician 4. Hospital admission indicated due to other medical/social reasons 5. Chest pain due to arrhythmia (new-onset atrial fibrillation, atrial flutter, sustained supraventricular tachycardia, second-degree or complete heart block, or sustained or recurrent ventricular arrhythmias) 6. Unable to provide written informed consent (lacks capacity) 7. Unwilling to provide written informed consent 8. Pain too severe to provide written informed consent 9. Follow-up will be impossible i.e. lives abroad or no fixed abode 10. Previous inclusion in the study 11. Prisoners 12. Pregnancy 13. Pre-existing renal failure requiring dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful early discharge, defined as discharge from hospital within four hours of arrival, without a Major Adverse Cardiac Event (MACE) occurring within 30 days of ED attendance | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Length of ED/ED Observation Unit (EDOU) stay, measured in hours. Discharge from the ED within four hours of attendance will be measured using electronic patient tracking systems in use at all study sites, according to the time the patient left the ED (including ED observation units). In the event that a participant is transferred from the ED, to an observation unit or inpatient bed within four hours of attendance and subsequently discharged, length of stay (minutes/hours) will be calculated from electronic patient records and tracking systems 2. Hospital admission and subsequent length of stay - time of admission and discharge to hospital – calculated from electronic patient records and tracking systems 3. Incidence of MACE, within 30 days of the index ED attendance – will be recorded on the SAE form, by the local ED Principal Investigator or designee with reference to relevant clinical information and responses to 30 day follow-up telephone assessments 4. Comparative costs. Resource use data to be collected from all participants with an initial hs-troponin below the LoD, at 30 (+5) days by telephone/by e-mail and electronic patient records (to include GP records where available) will include: use of health services in the last 30 days, length of any subsequent hospital stays (since initial visit to ED); hospital tests carried out during any subsequent hospital admissions, and time off work in the last 30 days. Participants with an initial hs-troponin below the LoD (irrespective of group allocation) will also be asked to complete a second EQ-5D health status questionnaire during their 30-day follow-up 5. Patient satisfaction (quantitative survey) measured using a bespoke written patient satisfaction questionnaire upon discharge from the ED 6. Acceptability to patients (qualitative methodology): up to 25 participant interviews will be conducted by phone using a topic guide to explore experiences of the participant’s stay in ED, any concerns or anxieties they migh | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed