None listed
Conditions
Brief summary
This quality improvement initiative plans to measure the effect of implementing a chest pain assessment pathway using a point-of-care (near to patient) highly precise blood test to exclude heart attacks, compared with the existing chest pain assessment pathway (the rural accelerated chest pain pathway (RACPP). The context for the study will be people who experience chest pain and attend a community health setting in rural hospitals and general practice and urban urgent care clinics in Aotearoa New Zealand. The RACPP includes a clinical assessment (the emergency department assessment of chest pain score (EDACS) of less than 16), an ECG (an electrode recording of the heart) and two troponin blood tests two hours apart that are below threshold. This pathway has been shown to be safe and effective at reducing the number of transfers to hospital or hospital admissions. The new pathway (ICare-RURAL POC) that includes the new blood test (Siemens Atellica VLTi) allows the following changes to the pathway. The threshold for EDACS is able to be raised to 21 and if the episode of chest pain began at least 3-hours ago, a single blood test only will be required. This brings chest pain assessment in-line with urban emergency departments and may enable patients to receive high quality care near to the patient’s home, whanau, community and work. The main outcome measure is the length of time in a health facility. The hypothesis is that the new intervention will reduce the time that patients will spend in health care facilities. Health facilities will all have at least 6 months on each arm (RACPP or ICare-RURAL POC) and the project will run for 18 months.
Interventions
The intervention replaces the existing point-of-care (POC) troponin test with a high-sensitivity POC troponin test. Patients that present to health care facilities will be assessed by their usual health care professionals (usually doctors and nurses) who will perform the assessment and blood tests. The length of time the clinical assessment will take will vary depending on the clinical workload of the facility, time elapsed since the onset of chest pain but will generally take less than 2-hours
The intervention replaces the existing point-of-care (POC) troponin test with a high-sensitivity POC troponin test. Patients that present to health care facilities will be assessed by their usual health care professionals (usually doctors and nurses) who will perform the assessment and blood tests. The length of time the clinical assessment will take will vary depending on the clinical workload of the facility, time elapsed since the onset of chest pain but will generally take less than 2-hours per participant. The higher sensitivity and precision of this test allows a modification of the Emergency department assessment of chest pain score (EDACS) threshold to 21 and the opportunity to stratify patients as having low-probability of acute myocardial infarction (AMI) after a single test, if their chest pain onset was at least 3-hours prior to the presentation. Patients will be classified as having a low-probability of AMI and suitable for community management if all the below are true: • EDACS less than 21 • There is no new ischaemia on ECG • and either: a. Chest-pain onset was 3hrs or greater prior to blood draw and the first (baseline) POC hs-cTn result was below a pre-defined rule-out threshold, or b. Serial POC hs-cTn results at least 2hrs apart are negative (below the upper-reference limit of the assay). These patients who have low probability of AMI can be discharged home and follow-up arrangements can be made by the treating health professional as clinically indicated using local guidelines. Patients that do not fulfil these criteria are at risk of AMI and should be transferred (if not at a hospital site) and admitted to hospital for further assessment. If there is a rise or fall in cTn of at least 20% then treatment for AMI should commence. This pathway is designed to assess the probability of AMI and not the underlying risk of coronary artery disease. Once AMI has been excluded, the opportunity should be used to assess and reduce this risk using evidence based assessment and treatment. The intervention will be introduced to clusters of facilities (facilities are randomised into clusters) in one-month intervals starting 6 months after the start of the project. There will be a run-in period of 1 month for health care facilities to embed the new troponin test and pathway in their clinical practice. Data collected from this period will not be analysed in the primary analysis. The intervention will remain in place at all sites for at least 6 months with a maximum of 12 months. The fidelity of the intervention will monitored using the data collection tool.
Sponsors
University of Otago
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
Adults at least 18 years old and having an assessment for possible acute myocardial infarction
Exclusion criteria
• ST-Segment elevation myocardial infarction (STEMI) • Patients died in the health facility due to a non-cardiac cause
Outcome results
None listed