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Trial registered on ANZCTR


Registration number
ACTRN12623001000695
Ethics application status
Approved
Date submitted
2/08/2023
Date registered
13/09/2023
Date last updated
25/07/2024
Date data sharing statement initially provided
13/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of behavioural interventions on care for low back pain in the Emergency Department (NUDG-ED): a randomised trial.
Scientific title
The effect of behavioural ‘nudging’ interventions on low-value care for low back pain in the Emergency Department (NUDG-ED): a 2x2 factorial, before-after, cluster randomised trial.
Secondary ID [1] 308221 0
None
Universal Trial Number (UTN)
Trial acronym
NUDG-ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain
 327979 0
Condition category
Condition code
Musculoskeletal 325037 325037 0 0
Other muscular and skeletal disorders
Emergency medicine 327880 327880 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will randomly allocate the 8 hospitals (clusters) into one of four groups: i) no intervention; ii) patient nudges; iii) clinician nudges; iv) patient nudges and clinician nudges for six months after the control period.

Patient nudges: Making decision information salient
Patient nudges will include 6 digital posters displayed on 55-inch LCD screens located in the ED waiting room. The messaging on the posters focuses on the lack of benefits and potential harms of non-indicated imaging and opioids. Patients will also have access to a more detailed information leaflet on imaging and opioids for back pain. The information materials were designed specifically for this study and have been tested in our pilot studies before.

Clinician nudges: computer alerts
At ED sites randomised to receive clinician nudges, we will implement three computer alerts that are triggered only for patients who are flagged in the workflow as presenting with back pain. Alert #1 appears when a clinician attempts to order any lumbar imaging test for a person with back pain. The alert reminds clinicians that imaging is not recommended without features of serious pathology and provides them clear guidance on what pathologies would warrant imaging. Alert #2 appears when a clinician attempts to administer an opioid medicine for a person with back pain. Before proceeding with the administration, the alert reminds clinicians that opioids are not recommended for back pain and provides a list of suggested non-steroidal anti-inflammatory drugs (NSAIDs) medicines to choose from instead. Alert #3 appears when patients with back pain are being discharged. This alert reminds clinicians that take home opiods are not recommended for uncomplicated back pain. This alerts also provides evidence-based advice on non-opioid care for patients at home.

To measure fidelity of the intervention, we will engagement with computerised nudges including number of overrides. This will be measured using routine workflow data and assessing the number of computerised alerts shown vs number of computerised alerts overridden (i.e. the decision to prescribe opioids/imaging was unchanged). We will also measure clinicians' awareness and opinion of interventions via a survey in both intervention and control groups.
Intervention code [1] 324680 0
Behaviour
Comparator / control treatment
Standard care in the ED. Eg, regular hospital communication.
Control group
Active

Outcomes
Primary outcome [1] 332857 0
The proportion of encounters for back pain due to a musculoskeletal condition where a person received a non-indicated imaging test, an opioid at discharge, or both, in ED over a 9-month period. Clinician researchers will perform chart reviews every month using a standardised form for all participants who present with back pain and receive imaging to understand and code if it was non-indicated imaging (that is, imaging provided in the absence of clinical features of serious pathology). Opioids at discharge for patients with low back pain will be coded as low-value. Clinician researchers will screen discharge letters of all participants.
Timepoint [1] 332857 0
Over a 3 month baseline period and 6 month intervention period
Secondary outcome [1] 414879 0
Patient experience with emergency care (2-items related to ‘Overall Assessment of ED Experience’ and 2-items from ‘Medical Provider’ from 36-item Press Ganey ED Survey)
Timepoint [1] 414879 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [2] 422323 0
Pain intensity (Numeric Pain Rating Scale of 0 to 10)
Timepoint [2] 422323 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [3] 422324 0
Duration of current back pain (Orebro Musculoskeletal Pain Questionnaire)
Timepoint [3] 422324 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [4] 422325 0
Health related quality of life (EQ-5D-5L)
Timepoint [4] 422325 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [5] 422326 0
Reassurance (Generic reassurance subscale from consultation-based reassurance questionnaire)
Timepoint [5] 422326 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [6] 422327 0
Patient participation in decision-making (CollaboRATE Tool- 10-point scale)
Timepoint [6] 422327 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [7] 422328 0
Referrals to specialist (from patient reported survey)
Timepoint [7] 422328 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [8] 422329 0
Intention to seek second opinion (A question from national patient safety foundation, AMA)
Timepoint [8] 422329 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [9] 422330 0
Patient beliefs about imaging and opioids for low back pain (2 imaging questions from Jenkins et al 2015 and a new statement on the effectiveness of opioids)
Timepoint [9] 422330 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [10] 422331 0
Service outcomes (routinely collected eMR data)
i) proportion of patients admitted to hospital (excludes patients sent to ED short stay units)
Timepoint [10] 422331 0
Over a 3 month baseline period and 6 month intervention period
Secondary outcome [11] 422332 0
Fidelity measures:
i) Engagement with computerised nudges including number of overrides- measured using routine workflow data and assessing the number of computerised alerts shown vs number of computerised alerts overridden
Timepoint [11] 422332 0
Cumulative data will be assessed at the conclusion of the 6 month intervention period
Secondary outcome [12] 422333 0
Unintended consequences (assesed using routinely collected eMR data)
i) Proportion of patients re-presenting with low back pain to the index ED within 48 hours
Timepoint [12] 422333 0
Over a 3 month baseline period and 6 month intervention period
Secondary outcome [13] 422334 0
Experiences with interventions (semi-structured interviews with patients and clinicians)
Timepoint [13] 422334 0
One week after index ED visit in the 6 month after period
Secondary outcome [14] 425352 0
Disability measured using Henschke et al. 2008 adaptation of item 8 of the SF-36
Timepoint [14] 425352 0
One week after index ED visit in the three month before period and 6 month after period
Secondary outcome [15] 425380 0
Service outcomes (routinely collected eMR data)
ii) Proportion of patients who receive advanced imaging tests (CT/MRI= yes, X-ray/no imaging= no)
Timepoint [15] 425380 0
Over a 3 month baseline period and 6 month intervention period
Secondary outcome [16] 425381 0
Service outcomes (routinely collected eMR data)
iii) Time in ED (triage time to ED discharge or admission time, including the time in short stay units)
Timepoint [16] 425381 0
Over 3 month baseline and 6 months intervention period
Secondary outcome [17] 425382 0
Service outcomes (routinely collected eMR data)
iv) Hospital costs (including intervention costs, that is, LCD screens, installation costs, staff time, IT support costs), cost-effectiveness
Timepoint [17] 425382 0
Over a 3 month baseline and 6 month intervention period
Secondary outcome [18] 425383 0
Service outcomes (routinely collected eMR data)
v) Use of opioids in ED (eMeds)
Timepoint [18] 425383 0
Over a 3 month baseline and 6 month intervention period
Secondary outcome [19] 425384 0
Fidelity measures:
ii) Clinicians' awareness and opinion of interventions via a survey (designed for this study)
Timepoint [19] 425384 0
Cumulative data will be assessed at the conclusion of the 6 month intervention period
Secondary outcome [20] 425386 0
Fidelity measures:
iii) Patient engagement with the QR code, that is, number of accesses measured via website analytics will be used to assess fidelity
Timepoint [20] 425386 0
Cumulative data will be assessed at the conclusion of the 6 month intervention period
Secondary outcome [21] 425387 0
Unintended consequences (assesed using routinely collected eMR data)
ii) Proportion of patients with unintended 30-day re-presentation
Timepoint [21] 425387 0
Over a 3 month baseline and 6 month intervention period
Secondary outcome [22] 425388 0
Unintended consequences (assesed using routinely collected eMR data)
iii) Proportion of patients who are readmitted
Timepoint [22] 425388 0
Over a 3 month baseline and 6 month intervention period
Secondary outcome [23] 425389 0
Unintended consequences (assesed using routinely collected eMR data)
iv) Proportion of patients who left the ED without treatment
Timepoint [23] 425389 0
Over a 3 month baseline and 6 month intervention period
Secondary outcome [24] 425390 0
Unintended consequences (assesed using routinely collected eMR data)
v) Proportion of patients diagnosed with non-musculoskeletal pain who were administered an opioid
Timepoint [24] 425390 0
Over a 3 month baseline and 6 month intervention period

Eligibility
Key inclusion criteria
Clinician participants will be ED staff at study sites who are involved in the care of patients presenting to ED with a primary complaint of low back pain. This includes physicians (Junior Medical Officer, Registrar, Consultant), nurses, and physiotherapists).

Patient participants will be 18 years or older, presenting with low back pain and diagnosed with back pain due to a musculoskeletal condition.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients diagnosed with a non-musculoskeletal condition e.g. renal colic.
People who required a translator service, and those without mobile number recorded will be excluded from the patient survey.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed - Randomisation by computer-generated random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To create the randomisation list a trial statistician will use computer-generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
2x2 factorial, open label, before-after, cluster randomised controlled trial design. This involves randomising clusters–in our case eight hospital EDs–to one of four groups after a 3-month period where all sites are in the control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be blinded, by intention-to-treat and guided by a published statistical analysis plan. Analysis will be conducted by an independent biostatistician and checked for accuracy.

Primary analysis: to evaluate the effect of the intervention on the proportion of encounters for back pain due to a musculoskeletal condition where low-value care was provided, we will use a multi-level regression model, with a random effect for cluster and patient (assuming some patients may have several encounters during the study period), a fixed effect indicating the group assignment of each cluster and a fixed effect of time.

Secondary analysis: dichotomous outcomes will be compared between groups using generalised estimating equations (GEE) considering clustering effects. Continuous secondary outcomes will be analysed using the same GEE model with appropriate link function.

Cost-effectiveness analysis: cost- effectiveness analysis of the NUDG-ED interventions compared with current emergency care will be done from the health system perspective. For this, we will measure all costs related to the delivery of the intervention (that is, LCD screens, installation costs, staff time, printed resources, IT support). We will also calculate the costs of imaging and opioid use in control and intervention groups. We will present the incremental cost-effectiveness ratio (ICER) as the incremental cost per patient avoiding low-value care. We will also estimate the incremental cost per quality adjusted life year (QALY) gained, using utility weights from the EQ-5D-5L.

Process analysis: a mediation analysis will estimate the extent to which intervention effects (or lack of effects) can be explained by changes in 1) patient beliefs, 2) patient reassurance, 3) clinician engagement with computer alerts, 4) perceived helpfulness of the computer alerts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/10/2023
Actual
17/05/2024
Date of last participant enrolment
Anticipated
29/07/2024
Actual
Date of last data collection
Anticipated
26/08/2024
Actual
Sample size
Target
2416
Accrual to date
644
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23390 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 23391 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 23393 0
Westmead Hospital - Westmead
Recruitment hospital [4] 23395 0
Fairfield Hospital - Prairiewood
Recruitment hospital [5] 23396 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 23826 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [7] 23827 0
Blacktown Hospital - Blacktown
Recruitment hospital [8] 24306 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 38790 0
2170 - Liverpool
Recruitment postcode(s) [2] 38791 0
2560 - Campbelltown
Recruitment postcode(s) [3] 38793 0
2145 - Westmead
Recruitment postcode(s) [4] 38795 0
2176 - Prairiewood
Recruitment postcode(s) [5] 38796 0
2747 - Kingswood
Recruitment postcode(s) [6] 39281 0
2770 - Mount Druitt
Recruitment postcode(s) [7] 39282 0
2148 - Blacktown
Recruitment postcode(s) [8] 39858 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 312476 0
Government body
Name [1] 312476 0
Australian National Health and Medical Research Council
Country [1] 312476 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The Unversity of Sydney, Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 314060 0
None
Name [1] 314060 0
None
Address [1] 314060 0
N/A
Country [1] 314060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311819 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311819 0
Ethics committee country [1] 311819 0
Australia
Date submitted for ethics approval [1] 311819 0
31/03/2023
Approval date [1] 311819 0
11/05/2023
Ethics approval number [1] 311819 0
2023/ETH00472

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

Contacts
Principal investigator
Name 122478 0
Dr Adrian Traeger
Address 122478 0
The University of SydneyFaculty of Medicine and Health, Sydney School of Public Health, Institute for Musculoskeletal HealthLevel 10N, King George V Building, Royal Prince Alfred Hospital (C39) |PO Box M179, Missenden Road, Camperdown | NSW | 2050
Country 122478 0
Australia
Phone 122478 0
+61 286276231
Fax 122478 0
Email 122478 0
[email protected]
Contact person for public queries
Name 122479 0
Sweekriti Sharma
Address 122479 0
The University of SydneyFaculty of Medicine and Health, Sydney School of Public Health, Institute for Musculoskeletal HealthLevel 10N, King George V Building, Royal Prince Alfred Hospital (C39) |PO Box M179, Missenden Road, Camperdown | NSW | 2050
Country 122479 0
Australia
Phone 122479 0
+61 2 8627 6231
Fax 122479 0
Email 122479 0
[email protected]
Contact person for scientific queries
Name 122480 0
Sweekriti Sharma
Address 122480 0
The University of SydneyFaculty of Medicine and Health, Sydney School of Public Health, Institute for Musculoskeletal HealthLevel 10N, King George V Building, Royal Prince Alfred Hospital (C39) |PO Box M179, Missenden Road, Camperdown | NSW | 2050
Country 122480 0
Australia
Phone 122480 0
+61 2 8627 6231
Fax 122480 0
Email 122480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD plans not yet decided


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18840Study protocol    Study protocol will be available online once publi... [More Details]
18841Statistical analysis plan    Statistical analysis plan will be available once p... [More Details]
19161Ethical approval    384855-(Uploaded-12-05-2023-12-08-07)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.