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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Public Health

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]

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]

Proportion of patients with LBP who are prescribed inappropriate medications (opioids/benzodiazepines)
Outcomes will be assessed by medical record review.

Timepoint [1]

Assessed every 2 weeks for 6 months pre- and post-implementation of the RIME intervention.

Secondary outcome [1]

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]