None listed
Conditions
Brief summary
The health sciences are replete with innovations promising improvements in health care delivery and outcome. Yet their clinical application based on intuition is often imprecise, conservative and beset with biases leaving these potential gains unrealised. To translate healthcare innovations into real patient and system benefits, clinical decisions and practice must evolve in parallel, supported by objective validated evidence. One such innovation is troponin testing for suspected acute coronary syndrome in the Emergency Department (ED), the most common cardiac test undertaken in Australia. Each new generation troponin assays offer greater diagnostic differentiation, but as yet no discernible improvement in management efficiency or effectiveness has occurred. Translating improved test performance into better patient care will require a more structured approach. In all South Australian (SA) public hospitals, 5th generation troponin assays have been implemented, but reporting of results has remained at previous generation levels (conventional reporting), providing a unique opportunity to robustly evaluate the impact of test reporting on patient outcomes.
Interventions
Intervention Arm: High-sensitivity/1-hour protocol.
Consenting participants will have a baseline troponin T taken upon ED arrival and a repeat sample taken 1 hour later. Both samples will be reported in high sensitivity and a disposition will be provided based on these results as follows:
Rule-out: baseline troponin less than 5ng/L if greater than 3 hour from the onset of symptoms OR baseline troponin equal to or less than 12ng/L with a change in troponin over 1 hour of less than 3ng/L: discharg
Intervention Arm: High-sensitivity/1-hour protocol. Consenting participants will have a baseline troponin T taken upon ED arrival and a repeat sample taken 1 hour later. Both samples will be reported in high sensitivity and a disposition will be provided based on these results as follows: Rule-out: baseline troponin less than 5ng/L if greater than 3 hour from the onset of symptoms OR baseline troponin equal to or less than 12ng/L with a change in troponin over 1 hour of less than 3ng/L: discharge to primary care with instructions regarding repeat episodes of chest pain and primary prevention advice. Rule-in: baseline troponin equal to or greater than 52ng/L OR a change over 1 hour of equal to or greater than 5ng/L: Admit to cardiology unit for ruling in as MI. Observe: baseline troponin between 13-51 ng/L OR a change in troponin over 1 hour of 3-4ng/L will be admitted to an inpatient or extended emergency care unit. Functional testing at clinician discretion with consideration of current statewide ED chest pain pathways and NICE guideline recommendations. Medical staff will be strongly encouraged to adhere to protocol-specified care pathways unless there is strong conflicting clinical judgement. High sensitivity troponin T reporting now is reported to 2 decimal places. Values will be rounded to the nearest whole integer in order to determine protocol-recommended pathway.
Sponsors
SA Emergency Department Working Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Clinical features of suspected ACS as the principal cause for investigation; b) Electrocardiogram (ECG) is interpreted as not reflecting coronary ischaemia; c) Patient is 18 years of age or older; d) Patient is willing to give written informed consent;
Exclusion criteria
a) E.D presentation is for non-ACS reasons; b) Patient has been transferred from another hospital; c) Patient has re-presented to the E.D for suspected ACS within 30 days of their previous presentation to the E.D for suspected ACS; d) Patient requires permanent dialysis e) Patient is unable to provide their clinical history due to language or comorbidity or decreased conscious state.
Outcome results
None listed