Clinical Trial Details

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

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Trial Information

Broad Health Condition Musculoskeletal

Specific Health ConditionOther muscular and skeletal disorders

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Royal Prince Alfred Hospital - Camperdown
Concord Repatriation Hospital - Concord
Canterbury Hospital - Campsie
Dubbo Base Hospital - Dubbo


Postcode
2050 - Camperdown
2139 - Concord
2194 - Campsie
2830 - Dubbo

Anticipated date of first participant enrolment4/09/2017

Anticipated date of last participant enrolment4/09/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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).
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 age18 Years

GenderBoth 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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Sydney
Primary Sponsor Address: The University of Sydney NSW 2006
Primary Sponsor Country: Australia

Trial websitewww.shapedtrial.com

Trial IDACTRN12617001160325

Contact person for information and recruitmentDr
Gustavo Machado
School of Public Health, The University of Sydney Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
+61 2 8627 6243
+61 2 8627 6262
Further information icongustavo.machado@sydney.edu.au
Australia