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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]

None

Universal Trial Number (UTN)

Trial acronym

NUDG-ED

Linked study record

Health condition

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

low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Emergency medicine

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]

Behaviour

Comparator / control treatment

Standard care in the ED. Eg, regular hospital communication.

Control group

Active

Outcomes

Primary outcome [1]

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]

Over a 3 month baseline period and 6 month intervention period

Secondary outcome [1]

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]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [2]

Pain intensity (Numeric Pain Rating Scale of 0 to 10)

Timepoint [2]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [3]

Duration of current back pain (Orebro Musculoskeletal Pain Questionnaire)

Timepoint [3]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [4]

Health related quality of life (EQ-5D-5L)

Timepoint [4]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [5]

Reassurance (Generic reassurance subscale from consultation-based reassurance questionnaire)

Timepoint [5]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [6]

Patient participation in decision-making (CollaboRATE Tool- 10-point scale)

Timepoint [6]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [7]

Referrals to specialist (from patient reported survey)

Timepoint [7]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [8]

Intention to seek second opinion (A question from national patient safety foundation, AMA)

Timepoint [8]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [9]

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]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [10]

Service outcomes (routinely collected eMR data)
i) proportion of patients admitted to hospital (excludes patients sent to ED short stay units)

Timepoint [10]

Over a 3 month baseline period and 6 month intervention period

Secondary outcome [11]

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]

Cumulative data will be assessed at the conclusion of the 6 month intervention period

Secondary outcome [12]

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]

Over a 3 month baseline period and 6 month intervention period

Secondary outcome [13]

Experiences with interventions (semi-structured interviews with patients and clinicians)

Timepoint [13]

One week after index ED visit in the 6 month after period

Secondary outcome [14]

Disability measured using Henschke et al. 2008 adaptation of item 8 of the SF-36

Timepoint [14]

One week after index ED visit in the three month before period and 6 month after period

Secondary outcome [15]

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]

Over a 3 month baseline period and 6 month intervention period

Secondary outcome [16]

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]

Over 3 month baseline and 6 months intervention period

Secondary outcome [17]

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]

Over a 3 month baseline and 6 month intervention period

Secondary outcome [18]

Service outcomes (routinely collected eMR data)
v) Use of opioids in ED (eMeds)

Timepoint [18]

Over a 3 month baseline and 6 month intervention period

Secondary outcome [19]

Fidelity measures:
ii) Clinicians' awareness and opinion of interventions via a survey (designed for this study)

Timepoint [19]

Cumulative data will be assessed at the conclusion of the 6 month intervention period

Secondary outcome [20]

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]

Cumulative data will be assessed at the conclusion of the 6 month intervention period

Secondary outcome [21]

Unintended consequences (assesed using routinely collected eMR data)
ii) Proportion of patients with unintended 30-day re-presentation

Timepoint [21]

Over a 3 month baseline and 6 month intervention period

Secondary outcome [22]

Unintended consequences (assesed using routinely collected eMR data)
iii) Proportion of patients who are readmitted

Timepoint [22]

Over a 3 month baseline and 6 month intervention period

Secondary outcome [23]

Unintended consequences (assesed using routinely collected eMR data)
iv) Proportion of patients who left the ED without treatment

Timepoint [23]

Over a 3 month baseline and 6 month intervention period

Secondary outcome [24]

Unintended consequences (assesed using routinely collected eMR data)
v) Proportion of patients diagnosed with non-musculoskeletal pain who were administered an opioid

Timepoint [24]

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]

Liverpool Hospital - Liverpool

Recruitment hospital [2]

Campbelltown Hospital - Campbelltown

Recruitment hospital [3]

Westmead Hospital - Westmead

Recruitment hospital [4]

Fairfield Hospital - Prairiewood

Recruitment hospital [5]

Nepean Hospital - Kingswood

Recruitment hospital [6]

Mount Druitt Hospital - Mount Druitt

Recruitment hospital [7]

Blacktown Hospital - Blacktown

Recruitment hospital [8]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment postcode(s) [1]

2170 - Liverpool

Recruitment postcode(s) [2]

2560 - Campbelltown

Recruitment postcode(s) [3]

2145 - Westmead

Recruitment postcode(s) [4]

2176 - Prairiewood

Recruitment postcode(s) [5]

2747 - Kingswood

Recruitment postcode(s) [6]

2770 - Mount Druitt

Recruitment postcode(s) [7]

2148 - Blacktown

Recruitment postcode(s) [8]

2200 - Bankstown

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The Unversity of Sydney, Camperdown, NSW, 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

South Western Sydney Local Health District (SWSLHD)Locked Bag 7279 Eastern Campus Liverpool BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2023

Approval date [1]

11/05/2023

Ethics approval number [1]

2023/ETH00472

Summary

Brief summary

NUDG-ED is a randomised trial that will investigate behavioural strategies to reduce the use of low-value care for low back pain in emergency department (ED). We will recruit ED clinicians who manage back pain, and patients 18 years or over presenting to ED with back pain with a musculoskeletal condition. We will randomly allocate hospital sites to receive i) waiting room messaging for patients on best care for back pain, ii) computer prompts reminding clinicians of the indications for imaging and opioids, iii) both interventions, or iv) no intervention. The primary outcome will be the proportion of low back pain encounters where a person received low-value diagnostic imaging or an opioid prescription at discharge from ED.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Adrian Traeger

Address

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

Australia

Phone

+61 286276231

Fax

[email protected]

Contact person for public queries

Name

Sweekriti Sharma

Address

Country

Australia

Phone

+61 2 8627 6231

Fax

[email protected]

Contact person for scientific queries

Name

Sweekriti Sharma

Address

Country

Australia

Phone

+61 2 8627 6231

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD plans not yet decided

What supporting documents are/will be available?

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

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically