Award-winning Clinical Trial Reduces Opioid Use by Changing ED Practice

woman suffering from lower back pain

A clinical trial supported by Sydney Health Partners has won multiple awards for
significantly reducing the use of opioids to treat emergency department (ED) patients suffering acute back pain.

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The Sydney Health Partners Emergency Department (SHaPED) trial tested ways to implement evidence-based clinical guidelines that recommend patients receive non-opioid treatments in the first instance.

SHaPED won the Trial of the Year Award from the Australia and New Zealand Musculoskeletal Clinical Trials Network in 2022, the 2018 NPS MedicineWise Award for Excellence in eHealth Resources and the 2018 Lyn March Award for Excellence from the Agency for Clinical Innovation (ACI). It was also a finalist in the 2019 NSW Health Awards (Value Based Healthcare) and was highly commended at the 2019 Sydney Local Health District (SLHD) Quality Awards.

Trialed in four EDs at SLHD and Dubbo Health Service, SHaPED encouraged busy doctors and nurses to follow the clinical guidelines of the ACI. Co-led by Dr Gustavo Machado, Dr Danielle Coombs and Dr Bethan Richards from the Institute for Musculoskeletal Health (IMH), SHaPED showed that an implementation strategy combining clinician education, education resources, and audit and feedback avoided use of opioids in 12 per cent of patients who presented to an ED with back pain.

The treatment did not negatively affect the patients’ satisfaction with care, pain scores or the impact of the back pain on their physical ability.

IMH Director Professor Chris Maher AM said opioid use for musculoskeletal conditions should be minimised where possible.

While there is no evidence that opioids are an effective treatment for acute back pain, we have plenty of evidence about the harms caused by opioid use,” he said. “Most of the thousands of people who have died in the United States from prescription opioid consumption, started taking the drugs because they had back pain

IMH Director Professor Chris Maher AM

The SHaPED team received $90,000 of seed funding from Sydney Health Partners in 2016, $315,000 from the NHMRC in 2017, and $20,000 from NSW Health’s ACI in 2018.

The trial found that a key to changing the treatment approach of ED doctors and nurses was presenting data about the scale of the opioid problem.

“As a part of the trial, we accessed almost real-time data on the number of opioids used for back pain and presented it to the ED clinicians using data visualisation in the form of a dashboard,” said Professor Maher.

“When we showed them the data, they said, ‘oh no, that’s not us, that’s another hospital’.”

“So, the doctors and nurses, because they were very busy, didn’t realise the scale of the problem, but when it was presented to them, they wanted to be part of the solution.” The ACI model of care for acute back pain suggests that patients should not be prescribed strong and potentially harmful pain medications like opioids before safer alternatives are tried.

“ED clinicians should use non-pharmacological strategies such as heat wraps first, simple pharmacological strategies such as Non-Steroidal Anti-Inflammatory Drugs second, and only then in selected people might they have to prescribe an opioid in the lowest dose for the shortest period possible,” said Professor Maher.

A follow-up study showed that the effect of the SHaPED trial on the behaviour of ED doctors and nurses was sustained for up to 30 months after the implementation of the clinical guidelines. There was also a significant improvement in the clinicians’ knowledge and beliefs about back pain.

Back pain is one of the top 10 conditions seen in EDs, but most ED clinicians are not taught the best way to manage it

Dr Coombs

The SHaPED trial demonstrated it is possible to change clinical practice at scale and, by doing so, benefit many patients.

“We had four hospitals, 269 clinicians and 4,491 patients involved in the trial,” said Dr Coombs.

“It was also very much real world. Sometimes, for example, we had to reschedule the training as the ED was full of emergency cases and staff were literally run off their feet. If you can work in partnership with the staff to improve care in a less-than-ideal environment, then it is possible in other settings.”

“The SHaPED trial also demonstrated that if we can get researchers and clinicians working together and moving between the two worlds, we will get research into practice more quickly.”

Dr Machado said a major implementation lesson from the trial was the importance of gaining support from senior stakeholders.

“The key to this was getting the ED directors and senior consultants on board,” he said. “They are the ones who can spread the word and motivate the junior ED clinicians to follow the recommendations.

“At a trial site where we had great buy-in from the ED director and some of the senior consultants and nursing staff, we saw the greatest reduction in opioid use.”

In 2023, a team of clinician-researchers at Royal Brisbane and Women’s Hospital began trialing a local adaptation of the SHaPED intervention in their ED. Results from the trial are expected by the end of 2024.