Pulmonary embolism (PE) refers to blood clots in the lung. They can cause sudden death, collapse, chest pain, shortness of breath yet sometimes they cause no symptoms at all and are discovered incidentally. As they can be severe, they have become regarded as a not-to-miss diagnosis. As they can present with a variety of symptoms, emergency clinicians consider the possibility of PE on a frequent basis.

When considering whether a patient has a PE, the clinician may confirm or exclude the diagnosis directly with definitive chest scans. However, these scans are time consuming, costly and have other side effects including exposure to radiation and to chemical contrast agents. When patients are assessed to be less likely of having a PE, it is often possible to safely exclude PE by applying a set of clinical decision rules or doing a blood test called a D-dimer. If the level of D-dimer is below a certain threshold, then PE can be excluded.

We aim to safely exclude PE without scans where possible. Evidence has been building that employing a higher D-dimer threshold is reasonable, yet uptake of this newer approach is limited. We hope to demonstrate that a higher threshold can work in Australia without compromising safety. This will be a large study that answers this question and if shown to be the case, then patient care can be improved while using less resources in busy emergency departments.

SPEED-ED Patient Information Sheet

The project will involve four essential work packages:

• Stakeholder engagement, evidence synthesis and iIMPROVE PSP pathway development. The team will co-design, evidence-based, tailored, consumer-focused PSP care pathways based on their previous research, evidence synthesis and guidelines, developed by and with consumers using established behaviour change and Learning Health System (LHS) frameworks to answer how to implement high-value care in complex systems.
• A stepped wedge cluster randomised trial to determine the implementation effectiveness of iIMPROVE PSP pathway at scale. Evaluation will use the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) framework.
• Economic Evaluation of iIMPROVE PSP pathway. A within-trial cost-effectiveness analysis will provide a compelling case for scale-up and economic modelling for longer-term benefits.
• The roadmap for national scale-up will include a survey, implementation toolkits and National Clinical Care Standard co-designed with stakeholders including the Australian Commission for Safety and Quality in Healthcare. This will build legacy implementation research capacity in emergency and respiratory care and drive future collaborative research.

“This is an elegantly simple problem; we should be treating the vast majority of patients with primary spontaneous pneumothorax (PSP) with a watchful waiting approach and therefore avoid unnecessary, painful and costly interventions,” Professor Egerton-Warburton said. “High-level evidence clearly demonstrates that this approach is safe and will reduce iatrogenic harm, hospital admissions, recurrence, surgery and days off work. It will deliver high-value care that is better for consumers and the health system.”

Having two spontaneous pneumothoraxes, the project’s consumer lead investigator Ethan has personally experienced the pain of the typical treatment for PSP.  His experience will offer the research team insight into the unnecessary harm that patients can experience when old, outdated guidelines are followed when providing care.

Ethan said that the chest-tube treatment he received caused more pain and discomfort than the collapsed lung itself. “I feel like the pain and scarring I experienced was due to a lack of evidence-informed practice,” he said. “I’m grateful that I have the opportunity to contribute to this research project, and that my experience can be used to improve care across Australia. I’m hopeful that through this research, people will receive more effective care for PSP, without unnecessary pain.”

We propose to conduct a multi-centre blinded cluster cross over randomised clinical trial (RCT) of plasmalyte (PL), a balanced salt solution versus normal saline (NS) in patients admitted to an Intensive Care Unit (ICU) with diabetic ketoacidosis (DKA), a life-threatening complication of diabetes mellitus. DKA results in elevated acid levels in the blood leading to severe dehydration and electrolyte imbalance.

ICU admission rates for patients with DKA in Australia has risen annually. In 2019 and 2020, there were 2751 and 2812 admissions to ICUs respectively. Almost all patients present through the Emergency Departments and in regional hospitals, they are often admitted to the ICU.

NS is often used as the first line fluid for dehydration, but NS use frequently results in persistent acidosis. We have shown in a pilot trial, conducted in 7 Queensland regional Emergency departments and ICUs, that the use of a balanced salt solution such as PL resulted in a more rapid resolution of acidosis with trends to shorter length of ICU and hospital stay as compared to NS. The efficacy of PL in DKA needs evaluation in a large clinical trial.

We plan to study 480 patients from Australia of whom a third will be expected to be enrolled in Queensland. Patients will be randomised to receive either NS or PL and the primary end point is hospital length of stay. This proposed trial will answer a fundamental clinical question and will inform policy and practice in Australia and New Zealand and around the world.