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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] 292587 0
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 304257 0
Acute exacerbation of chronic low back pain 304258 0
Condition category
Condition code
Musculoskeletal 303608 303608 0 0
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] 298793 0
Behaviour
Intervention code [2] 298810 0
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] 302961 0
Proportion of patients with acute low back pain receiving any imaging at the emergency department (yes/no)
Timepoint [1] 302961 0
at 5 (primary timepoint), 6 and 7 months after randomisation
Secondary outcome [1] 337568 0
Proportion of patients receiving advanced imaging (CT or MRI = yes, x-ray or no imaging = no)
Timepoint [1] 337568 0
at 5, 6 and 7 months after randomisation
Secondary outcome [2] 337569 0
Proportion of patients receiving prescription or administered analgesic medications (topical, oral, injection):
- Simple analgesics (e.g., paracetamol)
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Muscle relaxants
- Weak opioids
- Strong opioids
- Neuropathic pain medicines
- Other
Timepoint [2] 337569 0
at 5, 6 and 7 months after randomisation
Secondary outcome [3] 337570 0
Time in emergency department (triage time to discharge or admission time)
Timepoint [3] 337570 0
at 5, 6 and 7 months after randomisation
Secondary outcome [4] 337571 0
Proportion of patients admitted to:
- Emergency medical unit
- Rheumatology department
Timepoint [4] 337571 0
at 5, 6 and 7 months after randomisation
Secondary outcome [5] 337572 0
Proportion of patients referred to surgical specialist (referral for a post-discharge surgical consultation by the emergency department)
Timepoint [5] 337572 0
at 5, 6 and 7 months after randomisation
Secondary outcome [6] 337573 0
Proportion of patients re-presenting to the emergency department within 28 days
Timepoint [6] 337573 0
at 5, 6 and 7 months after randomisation
Secondary outcome [7] 337574 0
Proportion of patients re-admitted to hospital within 48 hours
Timepoint [7] 337574 0
at 5, 6 and 7 months after randomisation
Secondary outcome [8] 337575 0
Total health system costs (including intervention costs and health service utilisation costs)
Timepoint [8] 337575 0
at 5, 6 and 7 months after randomisation
Secondary outcome [9] 349715 0
Pain intensity (Numeric Rating Scale, range 0-10)
Timepoint [9] 349715 0
at 1, 2 and 4 weeks after emergency department presentation.
Secondary outcome [10] 349716 0
Physical function (PROMIS Short Form - Physical Function 4a)
Timepoint [10] 349716 0
at 1, 2 and 4 weeks after emergency department presentation.
Secondary outcome [11] 349717 0
Quality of life (PROMIS Scale - Global Health item 1)
Timepoint [11] 349717 0
at 1, 2 and 4 weeks after emergency department presentation.
Secondary outcome [12] 349718 0
Patient experience with emergency service (item 31 of the Emergency Department Patient Experience of Care (EDPEC))
Timepoint [12] 349718 0
at 1, 2 and 4 weeks after emergency department presentation.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using computer-generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
SHaPED will use a stepped-wedge cluster randomised controlled trial design. In this study design, clusters are randomised to cross from the control period (i.e., unexposed to intervention) to the intervention period at regular intervals (‘steps’) until all clusters have crossed to the intervention under evaluation. This design is particularly suited to interventions aiming to improve healthcare systems as all groups eventually receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the effect size of 10% absolute reduction (from 30% to 20%) in imaging referrals, combined with an alpha of 0.05 and assuming an Intraclass Correlation Coefficient (ICC) of 0.1, a total number of 1,920 low back pain presentations (on average 480 per cluster) to emergency departments is needed for this stepped-wedge cluster trial with 80% power. A preliminary analysis revealed that there were over 2,500 low back pain presentations to the participating emergency departments in 2015-16, showing feasibility of this trial.

Data analysis will be performed according to an intention-to-treat analysis, i.e. clusters will be analysed according to their randomised crossover time irrespective of whether crossover was achieved at the desired time. Firstly, we will investigate temporal trends in healthcare outcomes across the 12-month baseline observation period. In the situation of an underlying temporal trend, we will only include data for the previous three months as the baseline observation period. In our primary analysis, the 4-week intervention period will be excluded, but a secondary exploratory analysis will be performed including the intervention period into the intervention group. For the primary outcome analysis, logistic regression models with a random effect for cluster, a fixed effect indicating the group assignment of each cluster at each step, and a fixed effect of time (each step) will be used. A detailed statistical analysis plan will be developed prior to unblinding. Data will be analysed using SAS version 9.1.3 (SAS Institute Inc., Cary, NC).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2017
Actual
2/07/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
28/02/2019
Date of last data collection
Anticipated
28/02/2019
Actual
28/02/2019
Sample size
Target
1920
Accrual to date
Final
4824
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8685 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 8686 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 8687 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 8688 0
Dubbo Base Hospital - Dubbo
Recruitment postcode(s) [1] 16796 0
2050 - Camperdown
Recruitment postcode(s) [2] 16797 0
2139 - Concord
Recruitment postcode(s) [3] 16798 0
2194 - Campsie
Recruitment postcode(s) [4] 16799 0
2830 - Dubbo

Funding & Sponsors
Funding source category [1] 297163 0
Government body
Name [1] 297163 0
Sydney Health Partners
Country [1] 297163 0
Australia
Funding source category [2] 300186 0
Government body
Name [2] 300186 0
Agency for Clinical Innovation
Country [2] 300186 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 296182 0
None
Name [1] 296182 0
None
Address [1] 296182 0
None
Country [1] 296182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298330 0
Sydney Local Health District (RPAH zone)
Ethics committee address [1] 298330 0
Ethics committee country [1] 298330 0
Australia
Date submitted for ethics approval [1] 298330 0
27/03/2017
Approval date [1] 298330 0
04/04/2017
Ethics approval number [1] 298330 0
X17-0043

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76742 0
Prof Chris Maher
Address 76742 0
School of Public Health, The University of Sydney
Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 76742 0
Australia
Phone 76742 0
+61 2 8627 6263
Fax 76742 0
+61 2 8627 6262
Email 76742 0
christopher.maher@sydney.edu.au
Contact person for public queries
Name 76743 0
Gustavo Machado
Address 76743 0
School of Public Health, The University of Sydney
Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 76743 0
Australia
Phone 76743 0
+61 2 8627 6243
Fax 76743 0
+61 2 8627 6262
Email 76743 0
gustavo.machado@sydney.edu.au
Contact person for scientific queries
Name 76744 0
Rachelle Buchbinder
Address 76744 0
Monash Department of Clinical Epidemiology, Cabrini Hospital
183 Wattletree Rd, Malvern VIC 3144
Country 76744 0
Australia
Phone 76744 0
+61 3 9509 4445
Fax 76744 0
Email 76744 0
rachelle.buchbinder@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDesign and rationale for an implementation trial to improve care for low back pain in emergency departments.2018https://dx.doi.org/10.1136/bmjebm-2018-111070.67
EmbaseContinued opioid use following an emergency department presentation for low back pain.2022https://dx.doi.org/10.1111/1742-6723.13979
N.B. These documents automatically identified may not have been verified by the study sponsor.