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Trial registered on ANZCTR

Registration number

ACTRN12617001160325

Ethics application status

Approved

Date submitted

3/08/2017

Date registered

8/08/2017

Date last updated

21/06/2019

Date data sharing statement initially provided

21/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

SHaPED (Sydney Health Partners Emergency Department) trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute low back pain

Acute exacerbation of chronic low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

In the SHaPED trial, a retrospective baseline observation period of 12 months prior to implementation (from July 2017 to July 2018), where sites were unexposed to the intervention, will be used as the control. During this period, patients with low back pain would have received usual emergency department care according to local policy and guidelines. Outcome measures from the baseline control period will be extracted directly from participating emergency departments’ electronic record systems.

Control group

Historical

Outcomes

Primary outcome [1]

Proportion of patients with acute low back pain receiving any imaging at the emergency department (yes/no)

Timepoint [1]

at 5 (primary timepoint), 6 and 7 months after randomisation

Secondary outcome [1]

Proportion of patients receiving advanced imaging (CT or MRI = yes, x-ray or no imaging = no)

Timepoint [1]