Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000953437
Ethics application status
Approved
Date submitted
1/08/2025
Date registered
1/09/2025
Date last updated
1/09/2025
Date data sharing statement initially provided
1/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Safer AnalGEsis (SAGE) Trial
Scientific title
SAGE: Safer AnalGEsia: A pragmatic cluster randomised controlled trial addressing the use of high-risk medicines in people with chronic back and/or neck pain
Secondary ID [1] 314359 0
Nil
Universal Trial Number (UTN)
Trial acronym
SAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic back pain 337351 0
Chronic neck pain 337352 0
Condition category
Condition code
Musculoskeletal 333738 333738 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SAGE intervention is a GP-facing intervention which involves
• Training for GPs in deprescribing skills including communication training (using the motivational interviewing approach) and access to evidence-based deprescribing resources such as tapering algorithms;
• To assist the deprescribing process for their patients, GPs can (at no cost to the patient) conduct a long GP consultation; refer to trained physiotherapists for the provision of evidence-based, psychologically-informed physiotherapy sessions; provide alternate pain management options for patients at no cost to them; and patient education if needed.

GP training
To support GPs in communicating medication-related harms with patient-participants and provide tapering strategies informed by the evidence, we will use a communication support bundle, which will be packaged and delivered during an out-reach visit to GP. The communication bundle comprises the NPS MedicineWise “Opioids: Communication Videos alongside an educational video developed by the research team featuring an experienced GP, which will be presented during the face-to-face training with the study GPs. Together, the videos discuss conversations between GPs and patients, and outlines 'motivational interviewing', the recommended evidence-based communication approach for these conversations, including its underlying ethos, four main principles (empathy, developing discrepancy, rolling with resistance, supporting self-efficacy) and five key skills (open ended questioning, affirmations, reflections, summarisations, elicit shared understanding). Whilst the NPS MedicineWise communication videos discuss tapering in the context of opioid medicines, the messages presented are applicable to other high-risk medicine classes, including benzodiazepines and gabapentinoids.

The training will be delivered to study GPs face-to-face (in extreme circumstances, the training may be delivered via video call, i.e. Zoom). During this training, GPs will also be given access to trusted, up-to-date deprescribing resources developed by our partners, e.g. “Medicines Conversation Guide” and Opioid Deprescribing Guideline to support safe tapering of the target medicine(s). GPs will also be given access to trusted tapering algorithms for opioids, gabapentinoids and benzodiazepines e.g. those developed by NPS MedicineWise, The National Health Service (NHS) and Royal Australian College of General Practitioners. The resources offer GPs guidance on safe dose reduction, tailoring the deprescribing plan to the patient-participant, monitoring for withdrawal symptoms, making dose adjustments, and supporting patient-participants to identify and report withdrawal symptoms.

Deprescribing support
Long GP Consultation: The multifaceted deprescribing intervention will involve a trial-funded “longer” GP consultation. This consultation aligns with standard GP consultation time of a Medicare “Level C” consult (which is at least 20-minutes to less than 40 minutes in duration). This consultation will be provided once and scheduled within 6 weeks of identifying regular patient use of the target medicine and receiving patient consent. The “longer” consultation is intended to support the effective management of chronic conditions and will facilitate a deep discussion about strategies to taper the high-risk medicine (informed by the resources developed by the team). GPs will be asked not to charge Medicare for the consultation in addition to the remuneration they will receive as part of their involvement on the trial.

Participant education
GPs in the intervention arm will be trained to offer education and psychologically-informed guidance on the target high-risk medicine(s). GPs will be asked to discuss with the patient-participant the use and tapering of the target high-risk medicine, using the guidance provided in the Medicines Conversation Guide, Opioid Deprescribing Guide and tapering guides, and provide education. The education, delivered verbally during consultations with study GPs and phsyiotherapists, combines evidence-based messages on judicious use, harms, and safe disposal of opioids with management strategies endorsed in international back and/or neck pain guidelines, e.g. advice to stay active and avoid bed rest. These strategies assist with pain relief and can speed recovery from back and/or neck pain. Patients will be encouraged to ask questions about pain, discuss a pain management plan, including a tapering plan, and set achievable goals around this.

Consumer Medicines Information leaflet provided by study team
Each patient-participant in the trial will be provided with a Consumer Medicines Information (CMI) leaflet for the target-high risk medicine currently being used for the chronic back and/or neck pain following the baseline contact. The appropriate CMI will be determined during the baseline contact between the researcher and the patient-participant and provided by the study team. Further, a letter accompanying the CMI leaflets will also be provided by the study team, advising patient-participants to discuss any queries or concerns regarding the CMI leaflets with their doctor or pharmacist.

Alternate pain management assistance
To further support the tapering process, the trial will provide heat wraps, topical diclofenac gel and referral for psychologically informed physiotherapy sessions.

GP training will include training in the study protocol and process (<60min) for all GPs and training associated with the intervention for those randomised to the intervention group (one ~60min session). This training will happen before they start recruiting patient participants. Training will be delivered by the study team (trained researchers with a background in public health, pharmacy etc) and preferentially conducted face-to-face to deliver all relevant materials which could be either one-on-one or in groups (group size will depend on the number of eligible GPs in the practice). GPs will continue to have access to all materials and ongoing support throughout the trial. GP can contact the study team for more information at any point during the trial. The total duration of the study period for each GP will be as long as their involvement in the recruitment of participants. The overall duration of site participation in the trial will be 5 years (subject to extension depending on recruitment rate).
Intervention code [1] 331037 0
Behaviour
Comparator / control treatment
Study GPs in the control arm will be asked to provide the usual care they provide to their patients. The usual care will be treatment that GPs usually provide to their patients with chronic back and/or neck pain and may involve advice, prescription of pain medications etc.

In addition to the intervention or control, all patient-participants will be provided with a Consumer Medicines Information (CMI) leaflet for the target high-risk medicine they are currently using for chronic back and/or neck pain and will be advised to discuss any queries or concerns regarding the CMI leaflet with their doctor or pharmacist. The relevant CMI(s) will be determined during the baseline contact between the researcher and the patient-participant and provided by the study team either electronically or by post.
Control group
Active

Outcomes
Primary outcome [1] 341426 0
The cessation of the same target high-risk medicine (a benzodiazepine, gabapentinoid or opioid) prescribed by study GPs for patients with chronic back and/or neck pain at 1 year follow-up compared with the usual care control group. Cessation is defined as the absence of dispensation of the same target high-risk medicine (that the participant was prescribed persistently by the study GP at study entry). This includes a lack of substitution with another medicine from the same high-risk medicine class.
Timepoint [1] 341426 0
In the 4 weeks prior to the 1 year follow up
Secondary outcome [1] 447458 0
Proportion of participants who completely ceased the target high-risk medicine. Complete cessation is defined as the absence of dispensation for the same target high-risk medicine (that the participant was prescribed persistently by the study GP at study entry) sustained for three consecutive months immediately prior to the 1 year follow up. This includes a lack of substitution with another medicine from the same high-risk medicine class.
Timepoint [1] 447458 0
In the three consecutive months immediately prior to the 1 year follow up. The proportion of participants will be evaluated at study completion
Secondary outcome [2] 447462 0
Proportion of participants who reduced their dose. Any reduction in the dose of the target medicine(s) based on strength and quantity dispensed compared to the medicines(s) dispensed at baseline.
Timepoint [2] 447462 0
In the 4 weeks prior to the 1 year follow up. The proportion of participants will be evaluated at study completion
Secondary outcome [3] 447463 0
Substitution to another high-risk medicine from a different drug class. Proportion of participants who substituted the target high-risk medicine to another medicine from a similarly high-risk drug class.
Timepoint [3] 447463 0
In the 4 weeks prior to the 1 year follow up. The proportion of participants will be evaluated at study completion
Secondary outcome [4] 447465 0
Adjuvant anti-depressants dispensed on the PBS determined using the Defined Daily Dose (DDD)/1000 population/day
Timepoint [4] 447465 0
Over 1 year post-enrolment
Secondary outcome [5] 447467 0
Adjuvant Non-steroidal anti-inflammatory drugs (NSAIDs) dispensed on the PBS determined using the Defined Daily Dose (DDD)/1000 population/day.
Timepoint [5] 447467 0
Over 1 year post-enrolment
Secondary outcome [6] 447468 0
Cumulative dose of opioids dispensed. Calculated as the cumulative oral morphine milligram equivalent (MME) dose dispensed using dispensed strength, quantity and type of opioids over this period.
Timepoint [6] 447468 0
Over 1 year post-enrolment
Secondary outcome [7] 447469 0
Cumulative dose of gabapentinoids dispensed, by dispensed strength and quantity.
Timepoint [7] 447469 0
Over 1 year post-enrolment
Secondary outcome [8] 447470 0
Cumulative dose of benzodiazepines dispensed, by dispensed strength and quantity.
Timepoint [8] 447470 0
Over 1 year post-enrolment
Secondary outcome [9] 447751 0
Defined Daily Dose (DDD)/1000 population/day of gabapentinoids dispensed
Timepoint [9] 447751 0
Over 1 year post-enrolment
Secondary outcome [10] 447752 0
Defined Daily Dose (DDD)/1000 population/day of benzodiazepines dispensed
Timepoint [10] 447752 0
Over 1 year post-enrolment
Secondary outcome [11] 447753 0
Healthcare use. We will monitor all subsidised services from health providers, including Home Medicines Review (HMR) by HMR accredited pharmacists (MBS item number 900) We will monitor emergency department (ED) presentations and hospitalisations through linked data.
Timepoint [11] 447753 0
Over 1 year post-enrolment
Secondary outcome [12] 447754 0
Total cost of MBS usage and PBS usage (cost will be summarised descriptively). This will be assessed as a composite outcome
Timepoint [12] 447754 0
Over 1 year post-enrolment
Secondary outcome [13] 447755 0
Total cost of MBS usage
Timepoint [13] 447755 0
Over 1 year post-enrolment
Secondary outcome [14] 447756 0
Total cost of PBS usage
Timepoint [14] 447756 0
Over 1 year post-enrolment
Secondary outcome [15] 447759 0
Number of medicine-related poisonings
Timepoint [15] 447759 0
Over 1 year post-enrolment
Secondary outcome [16] 447760 0
Number of medicine-related deaths
Timepoint [16] 447760 0
Over 1 year post-enrolment
Secondary outcome [17] 447761 0
Cumulative medication exposure
Timepoint [17] 447761 0
Over 1 year post-enrolment
Secondary outcome [18] 447763 0
Global rating of change
Timepoint [18] 447763 0
Baseline, Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [19] 447764 0
Proportion of patient-participants per study arm who experience any adverse event such as nausea and vomitting
Timepoint [19] 447764 0
Week 6, 12, 26 and 52 post-enrolment. The proportion of participants will be evaluated at study completion
Secondary outcome [20] 447766 0
Frequency and nature of any adverse event per study arm
Timepoint [20] 447766 0
Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [21] 447768 0
Proportion of patient-participants per study arm who experience any serious adverse event (those resulting in hospitalisation, prolongation of hospitalisation, permanent disability etc)
Timepoint [21] 447768 0
Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [22] 447769 0
Frequency and nature of any serious adverse event
Timepoint [22] 447769 0
Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [23] 447770 0
Cause of serious adverse event
Timepoint [23] 447770 0
Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [24] 447771 0
Patient self report- Quality of life
Timepoint [24] 447771 0
Baseline, week 6, 12, 26 and 52 post-enrolment
Secondary outcome [25] 447772 0
Over-the-counter (OTC) analgesics, for pain, as per the generic name, categorised by type using an inductive approach at the time of analysis.
Timepoint [25] 447772 0
Baseline, week 6, 12, 26 and 52 post-enrolment
Secondary outcome [26] 449559 0
Use of medicinal cannabis reported as proportions (n/N (%)).
Timepoint [26] 449559 0
Baseline, week 6, 12, 26 and 52 post-enrolment
Secondary outcome [27] 449560 0
Medication withdrawal
Timepoint [27] 449560 0
Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [28] 449561 0
Planned or unplanned back or neck surgeries. This will be assessed as a composite outcome
Timepoint [28] 449561 0
Baseline, Week 6, 12, 26 and 52 post-enrolment
Secondary outcome [29] 449562 0
Other interventions for back and/or neck pain
Timepoint [29] 449562 0
Baseline, week 6, 12, 26 and 52 post-enrolment
Secondary outcome [30] 449563 0
The proportion of participants who ended a course of the target high-risk medicine(s). The course of medicine will be considered to have ended after 7 continuous days of no high-risk medicine use
Timepoint [30] 449563 0
Within the first 6 weeks post-enrolment. The proportion of participants will be evaluated at study completion
Secondary outcome [31] 449564 0
Return of unused high-risk medicine
Timepoint [31] 449564 0
At 12 weeks and 1 year post-enrolment
Secondary outcome [32] 449565 0
Diary to document use of heat wraps (Intervention arm only)
Timepoint [32] 449565 0
At 12 weeks post-enrolment
Secondary outcome [33] 449570 0
GP Study Clinician Questionnaires- Change in practice behaviour and confidence related to opioid therapy for the treatment of chronic pain. This will be assessed as a composite outcome
Timepoint [33] 449570 0
Collected pre-training, post GP recruitment, and at 6 months post-enrolment
Secondary outcome [34] 449571 0
GP Study Clinician Questionnaires- Concerns about analgesic prescription
Timepoint [34] 449571 0
Collected pre-training, post GP recruitment, and at 6 months post-enrolment
Secondary outcome [35] 450208 0
Physiotherapist Study Clinician Questionnaire- Psychologically Informed Practice (PIP) questionnaire to measure 4 domains of practice, including Knowledge about (components of) PIP treatment; Confidence to implement (components of) PIP; Likelihood to incorporate PIP treatment; and current practice. This will be assessed as a composite outcome.
Timepoint [35] 450208 0
Collected at pre-training and upon completion of delivering the intervention to 10 participants (i.e. at the completion of the 10th participant’s final report), or at site close out if less than 10 participants
Secondary outcome [36] 450841 0
Diary to document use topical diclofenac gel (Intervention arm only)
Timepoint [36] 450841 0
At 12 weeks post-enrolment
Secondary outcome [37] 451395 0
Non-pharmacological interventions (Including professional services and self care) for pain
Timepoint [37] 451395 0
Baseline, week 6, 12, 26 and 52 post-enrolment

Eligibility
Key inclusion criteria
Patient-Participants
• Adults (18 years or over)
• Experiencing chronic back and/or neck pain (pain duration > 3 months) with or without radiation to the leg or arm.
• Using a target high-risk medicine persistently (at least 3 dispensations of the same high-risk medicine (a benzodiazepine, gabapentinoid or opioid) prescribed by the study GP within the last 4 months for chronic back and/or neck pain with at least one of those dispensations within the last month).
• Sufficient understanding of English or translation available (in Arabic, Mandarin or Italian).
• Holds a current Australian Medicare card number (for data linkage purposes) and allow access to their Medicare/Pharmaceutical Benefits Scheme (PBS) information.
• Willing to consider their GPs recommendations regarding how to safely reduce the use of high-risk medicines
• Willingness to provide informed consent to participate in the trial.

Study GPs
• Be registered and maintain currency during the trial with the Australian Health Practitioner Regulation Agency (AHPRA).
• Has no restrictions on prescribing drugs of dependence, including opioids.
• Holds adequate insurance (public and professional liability).
• Consults with patients with chronic back and/or neck pain (with or without radiation to the arm and leg).
• Willing to consider tapering of the target high-risk medicine(s) for patients with chronic back and/or neck pain.

General Practices
• Able to provide study GPs within the practice access to practice software or prescription monitoring information, such as SafeScript to screen for regular use of the target high-risk medicines.

Physiotherapists
• Be registered and maintain currency during the trial with the Australian Health Practitioner Regulation Agency (AHPRA).
• Currently practising or working as a physiotherapist with at least 5 years’ experience.
• Has access to the internet or telephone (to deliver the intervention remotely).
• Holds adequate insurance (public and professional liability).
• Willingness to commit to the trial-funded training modules and webinars (~20 hours total) to prepare them for delivering the psychologically informed intervention to patient participants in the intervention arm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient-Participants
• Currently on a tapering plan with the GP for the target high-risk medicine for chronic back and/or neck pain.
• Receiving active treatment for cancer or palliative care.

Study GPs
• Received an educational outreach visit on deprescribing of the target high-risk medicine(s) within the past six months.

Physiotherapists
• None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation (using REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined by a blinded statistician using randomisation software and include permuted blocks of size 2 and 4. Randomisation will be at the site (general practice) level and will be stratified by remoteness (e.g. urban and regional/remote/very remote), and socioeconomic status of the practice site (based on socio-economic indexes for areas [SEIFA]). Randomisation and allocation will not involve patient-participants. Physiotherapists will not be randomised as they are only involved in the intervention. We will use stratified randomisation, by SEIFA (area-level socioeconomic status) and remoteness. SEIFA will be split into tertiles (highest, middle, lowest) based on the 2021 index for relative advantage and disadvantage (IRSAD). Remoteness will be classified into two categories based on the Accessibility/Remoteness Index of Australia (ARIA+) classification and based on the Australian Statistical Geography Standard (ASGS): Urban (major cities), Regional/Remote/Very remote. There will thus be two strata variables, one with two levels and one with three levels, giving a total of six strata. Separate randomisation schedules will be generated for each of the six strata, using permuted blocks.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analyses will follow an intention-to-treat approach. Dichotomous variables will be reported as proportions, n/N (%). Continuous variables will be reported using point and variability estimates (e.g. means and standard deviations or median and interquartile ranges).

Primary analysis will be performed using a mixed effects regression to estimate risk difference and risk ratios using trial group and time as the main covariate, with an interaction between them to allow change over time to vary between groups. Secondary outcomes will be analysed using the same methodological approach. Outcomes will also be reported descriptively as appropriate, e.g. proportion of participants per group reporting adverse events.

Sensitivity analyses of the impact of missing data will be conducted using multiple imputation, and under a range of ‘missing not at random’ scenarios (e.g. assumed success, assumed failure, last value carried forward). Sensitivity analysis will also be carried out to account for any new indication for use of the target high-risk medicine which is unrelated to the index condition.

Subgroup analyses will be performed on primary and secondary outcomes per i) medicine class (opioid analgesics, benzodiazepines and gabapentinoids or combinations of these) and ii) pain condition (back or neck pain or both).

A per protocol analysis involving a comparison of treatment groups including participants who adhered to the study intervention will be performed.

Health Economic Analyses
A within trial cost-effectiveness and cost-utility analysis will be conducted from the health care system perspective. Intervention-related costs (i.e. outreach visits, heat wrap therapy, diclofenac gel, physiotherapy sessions, patient education and training, time and financial costs of posting the heat wraps) will be collected using staff wage rate, trial financial records and site monitoring data to determine the stock of heat wraps and Diclofenac gel at GP clinic and provided to patients via express post-delivery at 1 year. Healthcare costs will be incorporated in the analysis, using administratively linked MBS, PBS and emergency department presentation and hospital admission costs, and patient-reported diaries for over-the-counter medicines. The health outcome measure will use PROMIS to estimate quality-adjusted-life years. To calculate the incremental cost-effectiveness ratio (ICER), linear mixed models will be used to analyse both costs and outcomes. An additional analysis will be conducted to compare the total PBS cost of analgesic medicines dispensed among patient-participants randomised to the intervention versus control over a one year period using the dispensed price for maximum quantity. The full economic analyses will be detailed in the statistical analysis plan.

As ~70% of the population of Australia is in urban areas, we will aim to match recruiting is the same proportion, with 70% from urban strata and 30% from regional/remote/very remote strata. This gives a target sample size of n = 21 sites in each of the urban strata, and n = 9 sites in each of the three regional/remote/very remote strata. To reduce potential disparity in the number of practices assigned to the intervention or usual care control, while maintaining allocation concealment, we will use randomly varying blocks of size 2 and 4. To allow greater recruitment from some strata than others without exhausting the randomisation schedule, schedules of n = 40 will be generated for each stratum (that is, a maximum of n = 40 clusters can be randomised to any particular combination of SEIFA and remoteness).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2029
Actual
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318879 0
Government body
Name [1] 318879 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 318879 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321342 0
None
Name [1] 321342 0
Address [1] 321342 0
Country [1] 321342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317493 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317493 0
Ethics committee country [1] 317493 0
Australia
Date submitted for ethics approval [1] 317493 0
03/02/2025
Approval date [1] 317493 0
07/07/2025
Ethics approval number [1] 317493 0
2024/HE001706

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

Contacts
Principal investigator
Name 141230 0
A/Prof Christina Abdel Shaheed
Address 141230 0
Institute for Musculoskeletal Health Level 10, North King George V Building, Royal Prince Alfred Hospital (C39) Missenden Road Camperdown NSW 2050
Country 141230 0
Australia
Phone 141230 0
+61 2 8627 6236
Fax 141230 0
Email 141230 0
[email protected]
Contact person for public queries
Name 141231 0
Dr Sweekriti Sharma
Address 141231 0
Institute for Musculoskeletal Health Level 10, North King George V Building, Royal Prince Alfred Hospital (C39) Missenden Road Camperdown NSW 2050
Country 141231 0
Australia
Phone 141231 0
+61 2 8627 6263
Fax 141231 0
Email 141231 0
[email protected]
Contact person for scientific queries
Name 141232 0
A/Prof Christina Abdel Shaheed
Address 141232 0
Institute for Musculoskeletal Health Level 10, North King George V Building, Royal Prince Alfred Hospital (C39) Missenden Road Camperdown NSW 2050
Country 141232 0
Australia
Phone 141232 0
+61 8627 6236
Fax 141232 0
Email 141232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• To be determined by the Chief Investigator of the Study

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting the chief investigator of the study at [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.