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Implementation of a model of care for acute low back pain in emergency departments

Implementation of an evidence-based model of care for acute low back pain in emergency departments: a stepped wedge cluster randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001160325
Acronym
SHaPED (Sydney Health Partners Emergency Department) trial
Enrollment
4824
Registered
2017-08-08
Start date
2018-07-02
Completion date
2019-02-28
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main evidence-practice gaps in emergency departments for patients presenting with acute low back pain include overuse of imaging, liberal use of opioids, and inappropriate admission to hospital. These practices are wasteful of scarce health resources and lead to worse patient outcomes. The Sydney Health Partners Emergency Department (SHaPED) trial will address these problems by improving clinical pathways through implementation of the ACI model of care for acute low back pain. The ACI model of care promotes best practice and collaboration across the care continuum. The SHaPED trial uses routinely collected measures of healthcare to judge success of the implementation of the model of care. We will use these same measures to monitor whether the improved outcomes are sustained at the SHaPED trial sites and also at other sites when we scale up the project. The SHaPED trial will implement the ACI model of care for acute low back pain at three urban and one rural emergency department in NSW: Royal Prince Alfred Hospital, Concord Repatriation General Hospital, Canterbury Hospital, and Dubbo Base Hospital. After a retrospective control period of 12 months, where the emergency departments are not exposed to the intervention, each emergency department will randomly and sequentially crossover from control to intervention periods, until all emergency departments are exposed to the intervention. This study design, known as a stepped wedge cluster randomised controlled trial, is particularly suited for the evaluation of policy interventions and healthcare service delivery. Participants are emergency department clinicians (such as medical doctors, nurses, and physiotherapists). The 4-week initial intervention period, targeting emergency clinicians, comprises of printed and electronic educational materials, weekly educational meetings, and an audit and feedback approach focussed on the outcomes of the study. Outcomes are routinely collected measures of imaging referrals (primary outcome), opioid prescription, and inpatient admission. Data will be extracted directly from participating hospitals’ electronic record systems, such as the Sydney Local Health District Targeted Activity and Reporting System (STARS).

Interventions

The Agency for Clinical Innovation (ACI) has recently launched a model of care for acute low back pain that could be applied in both primary care and emergency department settings. The ACI model of care was developed in collaboration with policy makers, clinicians, consumers and researchers, and distils the high quality evidence in this area to formulate key messages for practice. Briefly, the model provides different care pathways according to a classification based on a diagnostic triage (non-

The Agency for Clinical Innovation (ACI) has recently launched a model of care for acute low back pain that could be applied in both primary care and emergency department settings. The ACI model of care was developed in collaboration with policy makers, clinicians, consumers and researchers, and distils the high quality evidence in this area to formulate key messages for practice. Briefly, the model provides different care pathways according to a classification based on a diagnostic triage (non-specific low back pain, low back pain with leg pain, suspected serious spinal conditions). Then, risk stratification is used to guide the amount and type of treatment provided; including personalised evidence-based health education and treatment. Lastly, follow-up reviews are scheduled to monitor individuals’ progress. The ACI model of care can be accessed at: https://www.aci.health.nsw.gov.au/resources/musculoskeletal/management-of-people-with-acute-low-back-pain/albp-model. A framework has been proposed to facilitate the implementation of research evidence into clinical practice, known as The Knowledge-to-Action Process. This framework links the various types of research enquiry with the key steps in the research translation cycle. The process consists of the knowledge creation cycle and the action cycle, and involves end users of research (e.g., policymakers, clinicians and patients) to facilitate engagement with the implementation strategy. We will use this framework to develop a tailored intervention strategy to implement the ACI model of care at the participating emergency departments. Engagement of local opinion leaders that are respected and influential at each site is an important element in promoting and maintaining local interest in the implementation process. Thus, implementation will begin with visits to each participating emergency department to establish collaborations and approvals, and to further assess organisational issues and potential barriers to the implementation program, such as intake and flow of patients with low back pain, assessment of current practices, acceptability of new model, and specific roles of emergency clinicians. We will map existing models of care at each emergency department that are used to guide management of patients presenting with acute low back pain. Then, we will work with local clinical staff to incorporate important features of existing models to the recommendations and principles outlined in the ACI model of care. A multi-faceted intervention package will be used to implement the ACI model of care at the emergency departments. Briefly, the initial 4-week intervention will consist of printed and electronic educational materials, educational seminars and educational outreach, website support, posters, and an audit and feedback approach. Clinician participants will receive a copy of the model and other printed educational materials, as well as access to additional online support tools. Experienced clinicians, research staff, and local opinion leaders will deliver the interactive educational seminars and educational outreach. An audit and feedback approach focussed on the outcomes of the study will also be used to enhance our implementation program. The implementation intervention will be tailored for each site by adapting knowledge resources (e.g., printed decision aids, patient resources) to the local context and by working with local opinion leaders (e.g., directors of emergency department) to address potential barriers to implementing the ACI model of care. These instructions, measures, and training materials will be hosted online during the implementation phase on the University of Sydney website. Due to the nature of the intervention, it will not be possible to blind clinician participants to the intervention. Details of the implementation intervention: 1) Provide emergency clinician information package: - Deliver printed copies of the ACI Model of care (full version and executive summary) to clinician participants. - Create a list of “red flags” to screen for serious pathologies from the ACI Model of care and deliver a printed version to clinician participants. - Create posters outlining the ‘10 principles’ of the ACI model of care, as well as the clinical pathways and place them at key locations of each participating emergency department. - Inform clinician participants about and provide them access to online videos and other electronic educational materials to recommend patients with acute low back pain at discharge. 2) Provide patient information package: - Encourage clinician participants to provide a printed copy of the ACI Consumer Information document to patients with acute low back pain during emergency department visit. - Where the majority of the patient population do not speak English, encourage clinician participants to provide a copy of the Emergency Care Institute (ECI) Patient Factsheet for acute low back pain (available in six languages). - Create posters outlining four myths of acute low back pain management and placed them at the reception area of each emergency department. 3) Deliver emergency clinician education: - Educational seminars will be delivered by an experienced clinician (Dr Chris Needs) at week 1 of the intervention period. Booster sessions in the first week will also be conducted by local investigators (e.g., directors of emergency department, clinical educators) as required, as well as in weeks 2-4. - The educational sessions will be conducted primarily during the existing regular clinical staff meetings, but additional sessions will be scheduled to reach all clinician participants. The format of the seminars consists of a mini-lecture and interactive group discussions and will last for 20-40 minutes. - During the educational seminars, clinician participants will be trained on history taking and examination of patients with acute low back pain, on how to use SNOMED diagnosis codes, and will be encouraged to follow the recommendations in the ACI model of care to manage these patients, with focus on the outcomes of this study (i.e., imaging, opioids, and inpatient admission). - During weeks 1-4, individual meetings with clinician participants will be scheduled as required to cover the key messages and principles outlined in the ACI model of care. 3) Develop audit and feedback focussed on study outcomes: - Each emergency department and clinician participants will receive at the first educational seminar session emergency department level feedback on the 12-month retrospective data performance against the outcomes of this study (e.g., imaging, opioid prescribing, inpatient admission). - This audit and feedback approach will be repeated each month after the implementation of the model of care during the regular emergency staff meetings until the end of the 3-month follow-up period.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Clinician participants Clinician participants included in the SHaPED trial will be emergency clinical staff, such as physicians, nurses, and physiotherapists, who routinely manage patients presenting to emergency departments with a primary complaint of low back pain. Potential clinician participants will be invited by the Principal Investigator of each emergency department and will receive a Participant Information Statement. Research staff will verbally explain the information provided in this document to fully inform potential clinician participants of the risks and benefits of their participation. In addition, the research staff will be available to answer any questions to ensure that potential clinician participants fully understand the implications of their decision. A written Participant Consent Form will be obtained from all participating clinicians prior to randomisation. Patient participants We will use codes from the Systematised Nomenclature of Medicine - Clinical Terms - Australian version, Emergency Department Reference Set (SNOMED CT-AU [EDRS]) to identify low back pain presentations to the emergency departments. Presentations with codes related to low back pain with non-specific cause or those associated with neurological signs and symptoms (such as sciatica and lumbar spinal stenosis) will be included. All patients with low back pain with or without leg pain presenting to participating emergency departments will be referred to a brief self-reported online questionnaire to evaluate the effectiveness of the implementation of the ACI model of care on patient-reported outcomes.

Exclusion criteria

Representations to the emergency department within 48 hours or low back pain presentations related to serious spinal pathologies (such as lumbar fracture or cauda equina syndrome) will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026