Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001536752
Ethics application status
Approved
Date submitted
22/11/2022
Date registered
13/12/2022
Date last updated
4/04/2024
Date data sharing statement initially provided
13/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Reinforcing Informed Medication prescription for low back pain in the Emergency department (RIME): a controlled interrupted time-series implementation study
Scientific title
Reducing Inappropriate Medications for low back pain in the Emergency department (RIME): a controlled interrupted time-series implementation study assessing use of an educational clinical decision-making tool for emergency department clinicians
Secondary ID [1] 308458 0
Nil Known
Universal Trial Number (UTN)
U1111-1285-2972
Trial acronym
RIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 328261 0
Condition category
Condition code
Musculoskeletal 325305 325305 0 0
Other muscular and skeletal disorders
Public Health 325380 325380 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The RIME study is a prospective, implementation, and evaluation research study, of controlled Interrupted Time Series design. This design is recommended by Cochrane EPOC as it permits evaluation of outcomes before and after the intervention implementation and compares the intervention site with a control site in order to detect potential confounding from simultaneous events. It is a stronger design than a pre/post evaluation in one Emergendy Department (ED) only and allows robust conclusions about change in outcomes OVER time in our Royal Brisbane Women's Hospital (RBWH) ED as well as COMPARED with a control site. The setting is two Metro North Health tertiary EDs: the RBWH ED (intervention site and the largest hospital in Queensland) and the Prince Charles Hospital (TPCH) ED (control site).
Implementation plan: The study comprises three phases:
Phase 1: Usual Care before the intervention (6 months) will comprise data collection during a usual care phase at both the intervention (RBWH) and control (TPCH) sites. Data will be extracted from routinely collected ED medical records on medication prescriptions (primary outcome) for a consecutive sample of patients presenting with LBP to the ED over a period of 6 months, and the secondary outcomes of patient admissions, provision of patient education, time to mobilisation, imaging requests, and hospital healthcare use.
Phase 2 (12 weeks): is the intervention implementation phase during which the multifaceted intervention will be introduced within the RBWH ED, and clinicians trained and supported to improve their practice. At the control site (TPCH) ED, clinicians will continue with usual care without any intervention.
The implementation of the RIME intervention will be underpinned by the Knowledge-to-Action framework (as per the SHaPED trial; ACTRN12617001160325), incorporating evidence-based implementation strategies specifically targeting the behaviour of ED clinicians at the RBWH. Our intervention components target the previously identified barriers of knowledge (through education and educational materials), skills (through education, time for simulated practice in education sessions), workflow uncertainty (through formal patient flow-charts in the ED), patients’ expectations (through patient focused educational material), treatment alternatives (recommended medications and non-pharmacological interventions, time in patient consultations in the ED (high quality patient educational material) and variation in practice (audit and feedback with individualised feedback at the level of each ED clinician). The COM-B behaviour change theoretical framework11 has been used to shape the implementation plans to support behaviour change in ED clinicians to enhance capability, opportunity, and motivation to improve clinical practice for LBP patients in the ED.
Specifically, the RIME intervention will comprise the following 6 components:
1. Educational Seminars: This will include structured Best Practice Updates from experienced ED clinicians (i.e. Emergency Physiotherapy Practitioners, Emergency Medical Consultants) that focus on knowledge and skills for assessing, managing, educating, and referring patients according to the Agency for Clinical Innovation (ACI) model of care for LBP. Additional training from study team experts in the management of low back pain and rehabilitation , will reinforce the significance of best practice management principles focusing on the importance of early mobilisation. These Best Practice sessions will be offered on numerous occasions throughout the 12-week intervention period in protected teaching time, either in teaching rooms or in the RBWH ED itself. All ED clinicians will be invited to participate and clinician participation in the education sessions will be tracked through a logbook, with reminders sent and personal communication from the study team and ED clinical leads where needed. It is envisaged that all clinicians will attend at least one such session of 30 minutes duration. Clinicians will be sent regular, weekly, email communications from the trial team, and staff room posters and flyers will be used to encourage participation and uptake of the advice.
2. Educational materials: Materials provided to ED clinicians will include a hard copy of the model of care document, a link to an already established and contemporary evidence-based website (https://mybackpain.org.au/), and the formalised clinical flow chart to support clinical decision-making such as the appropriate use of analgesic medicines. Posters highlighting key messages about benefits and harms of opioid medicines, lumbar imaging, and inpatient admission will be displayed throughout the ED. Anonymised patient cases from phase 1 will be discussed showing examples of poor practice and good practice. Patient educational materials (based on the ACI and mybackpain websites) and scripts to guide conversations with patients will be provided so that clinicians can use these to educate patients more easily. All this material will be developed by the trial team, drawing from a number of resources such as the SHaPED trial material, online material and own material.
3. Provision of alternative treatment options for LBP: Non-opioid pain medicines will be made more easily accessible to clinicians as an evidence-based alternative to opioid medicines or muscle relaxants. Heat wraps (used as a non-pharmacological modality for pain relief) will also be made available to clinicians with encouragement to use these as alternatives to inappropriate pharmacological treatments.
4. Fast-track referral to outpatient services: Clinicians will be educated on the referral pathways options available for follow-up physiotherapy management, when such referrals are warranted, and how to facilitate the referral process in collaboration with the patient. Referral pathways include private physiotherapy services within the primary care setting, public physiotherapy outpatient services, and advanced-practice musculoskeletal physiotherapy screening services (e.g. RBWH Spinal Physiotherapy Screening Clinic).
5. Audit and feedback: Clinicians will be provided with structured audit and feedback reports on department-level and individual clinician-level medication prescriptions, inpatient admission rates, time to mobilisation, provision of patient education, and lumbar spine imaging requests. Feedback will be offered by Senior ED clinicians at an ad-hoc basis. Data from phase 1 (actual ED practice data) will be analysed and key findings summarised at departmental level and clinician level (reports will compare each clinician’s practice patterns in phase 1, each clinician will be able to identify themselves in the reports but not other clinicians). Phase 1 data will be used to stimulate discussion about variation in practice in the management of LBP in the ED. During Phase 2, we will continue to extract routinely collected data on the primary and secondary outcomes, conduct audits and provide reports at department level and individual clinician level, anticipated to be monthly (4 weeks after the start of Phase 2, and at 8 weeks and 12 weeks).
6. Support from an ED ‘RIME Implementation Champion’: A key feature of our implementation is inclusion of a dedicated ‘Implementation Champion’ who will be an experienced ED clinician and have direct oversight and influence of the implementation on the ground within the ED. We have specifically targeted an experienced ED clinician (AI Heine) to undertake this role, as champions are considered vital to successful implementation and change in their own sphere of influence, particularly when intrinsically motivated and enthusiastic about the practices they promote. The RIME implementation champion will support reinforcement of implementation aims with staff, provide personal feedback sessions, and offer one-to-one or small group discussions with ED staff as needed.
Phase 3 Care after the intervention (6 months): the same data will again be extracted from the routinely collected data in the ED medical record, as per Phase 1. Clinicians will be able to continue to use the knowledge and materials introduced in phase 2. A new cohort comprising a consecutive sample of patients presenting with LBP to the ED over a period of 6 months will form the sample in phase 3. We will collect the same patient anonymised data from the medical records at both the intervention ED (RBWH) and control (TPCH).
Phase 3 will also include the nested process evaluation, comprising qualitative semi-structured interviews to gain a deeper understanding of ED clinician perspectives of the intervention and to understand how best to sustain the benefits of the intervention beyond the study.
None of this strategies and resources will become available to TPCH ED clinicians for the duration of the study, as TPCH ED is the control arm of this study.
Intervention code [1] 324902 0
Treatment: Other
Comparator / control treatment
The Prince Charles Hospital (TPCH) Emergency Department (ED) is going to serve as the control arm for this study. Patients presenting with acute low back pain in TPCH ED will receive usual care comprising of:
- Triage for the purpose of exclusion of red flags (serious pathology such as infection, fracture, malignancy, serious neurological deficits etc)
- provision of analgesia
- education and advice for self management of the condition
- referral to outpatient physiotherapy (if appropriate)
The RIME intervention will not be made available to TCPH ED clinicians for the duration of the study. Pending the outcome of the study, RIME materials will be rolled out on all EDs of the Metro North Hospital and Health Service (MN HHS) if appropriate.
Control group
Active

Outcomes
Primary outcome [1] 333172 0
Proportion of patients with LBP who are prescribed inappropriate medications (opioids/benzodiazepines)
Outcomes will be assessed by medical record review.
Timepoint [1] 333172 0
Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention.
Secondary outcome [1] 416048 0
Proportion of patients with LBP who are admitted to hospital, This information will be recorded by the treating clinician to the patient's medical record and data will be obtained through medical record review.
Timepoint [1] 416048 0
Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention
Secondary outcome [2] 416350 0
Received mobilisation (including time to mobilisation). This information will be recorded by the treating clinician to the patient's medical record and data will be obtained through medical record review.
Timepoint [2] 416350 0
Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention
Secondary outcome [3] 416351 0
advice/education received by the patient at the time of attendance of the ED with a diagnosis of low back pain. This information will be recorded by the treating clinician to the patient's medical record and data will be obtained through medical record review.
Timepoint [3] 416351 0
Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention
Secondary outcome [4] 416352 0
lumbar imaging prescribed and carried out to patients attending the emergency department with a diagnosis of low back pain. This information will be recorded by the treating clinician to the patient's medical record and data will be obtained through medical record review.
Timepoint [4] 416352 0
Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention
Secondary outcome [5] 416353 0
re-presentation to ED within 6 months. This information will be recorded by the treating clinician to the patient's medical record and data will be obtained through medical record review.
Timepoint [5] 416353 0
Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention

Eligibility
Key inclusion criteria
All patients over the age of 18 who present with a diagnosis of acute low back pain in the emergency departments of the Royal Brisbane Women's Hospital (RBWH) and The Prince Charles Hospital (TPCH).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are found to have severe neurological disorders, Cauda Equina Syndrome, infection, multi-trauma, fractures of the spine, malignancy, psychiatric disorders and mental health disorders.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
this is a two arm study, with the Royal Brisbane Women's Hospital Emergency department assigned to receive the RIME intervention whilst the Prince Charles Hospital emergency department is going to act as the control where they will not receive the RIME intervention for the duration of the study.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analyses: Segmented Regression and graphical display of the timeseries data will be used to evaluate the immediate (level) changes in the fortnightly rate of the primary and secondary outcomes, as well as changes in the trend (slope), for the intervention group using the approach proposed by Lopez et al. This first stage involves separate analysis of the intervention and control series. Where a change is observed in the control series, a single model that includes indicator variables for the intervention or control series as interaction terms will be considered, in addition to creating a new series of the ratio or difference between the intervention and control series at each time point for use in a segmented regression. A single-model approach tests the differential effects of the intervention (level or slope change) between the groups and highlights the presence of potential confounders. In addition to assessing for confounding, and considering whether a single-model is required, the autocorrelation between timepoints will be evaluated using the Durbin Watson statistic. Sensitivity analyses concerning the starting point of the ‘post-implementation’ period will be undertaken, based on the number and distribution of clinicians engaging in the intervention over the 12-week intervention period. Primary and secondary outcomes will also be collected during the intervention period and included in sensitivity analyses of the intervention effect. In addition to the segmented regression, descriptive statistics (mean [standard deviation], median [IQR], count [percentage]) will be used, as appropriate, to describe the cohort at both RBWH and TPCH EDs. Comparisons between the two cohorts will be explored using t-tests, Mann-Whitney U tests and chi-squared tests, depending on the format and normality of the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
1/03/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
2000
Accrual to date
1501
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23613 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 23614 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 39032 0
4029 - Herston
Recruitment postcode(s) [2] 39033 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 312701 0
Charities/Societies/Foundations
Name [1] 312701 0
HCF Research Foundation
Country [1] 312701 0
Australia
Primary sponsor type
Government body
Name
Metro North Health and Hospital Service
Address
Level 14, Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 314319 0
None
Name [1] 314319 0
Address [1] 314319 0
Country [1] 314319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312001 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 312001 0
Ethics committee country [1] 312001 0
Australia
Date submitted for ethics approval [1] 312001 0
01/09/2022
Approval date [1] 312001 0
26/09/2022
Ethics approval number [1] 312001 0
87995; HREC/2022/MNHA/87995

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

Contacts
Principal investigator
Name 123130 0
A/Prof Shaun O'Leary
Address 123130 0
Physiotherapy Department, Level 2
Royal Brisbane Women's Hospital
Butterfield Street
Herston 4029
Queensland
Country 123130 0
Australia
Phone 123130 0
+61 7 336 52209
Fax 123130 0
Email 123130 0
s.oleary@uq.edu.au
Contact person for public queries
Name 123131 0
Panos Barlas
Address 123131 0
Jamieson Trauma Institute
Block 7, Level 13
Royal Brisbane Women's Hospital
Butterfield Street,
Herston 4029
Queensland
Country 123131 0
Australia
Phone 123131 0
+61455022424
Fax 123131 0
Email 123131 0
panos.barlas@health.qld.gov.au
Contact person for scientific queries
Name 123132 0
Shaun O'Leary
Address 123132 0
Physiotherapy Department, Level 2
Royal Brisbane Women's Hospital
Butterfield Street
Herston 4029
Queensland
Country 123132 0
Australia
Phone 123132 0
+61 7 336 52209
Fax 123132 0
Email 123132 0
s.oleary@uq.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17674Study protocol    385018-(Uploaded-22-11-2022-15-59-00)-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.