None listed
Conditions
Brief summary
This study evaluates the effect of an educational outreach visit promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids on general practitioner prescribing of opioids dispensed to their patient-participants with low back pain over 1 year from index visit. We hypothesise the intervention will reduce opioid medicines dispensed, harms (adverse events, poisonings, hospitalisations) and result in no worse clinical outcomes such as pain, disability, mental health, and quality of life, and be cost-effective. Methods: At least 40 General Practices will be recruited and randomly assigned to receive training in the opioid stewardship intervention or assigned to the usual care they provide (no outreach visit). Patient-participants will be provided with a Consumer Medicines Information leaflet for the opioid medicine(s) prescribed at the enrolment visit either electronically or via post. This will be determined during the baseline follow-up between the researcher and the patient-participant and provided by the study team
Interventions
GPs will receive a baseline educational outreach visit of 0.5-1 hour duration and will also be given resources to implement the opioid stewardship intervention. The support material comprises patient education material “5 questions to ask about using opioids for back pain and osteoarthritis” (designed specifically for the trial) and heat wraps for pain relief (staged supply of up to 12 weeks).
Patient participants will continue to be followed up until 1 year post enrolment.
The topics covered
GPs will receive a baseline educational outreach visit of 0.5-1 hour duration and will also be given resources to implement the opioid stewardship intervention. The support material comprises patient education material “5 questions to ask about using opioids for back pain and osteoarthritis” (designed specifically for the trial) and heat wraps for pain relief (staged supply of up to 12 weeks). Patient participants will continue to be followed up until 1 year post enrolment. The topics covered during the education visit are: Judicious prescribing of opioids and potential harms of opioid use Pharmacological and non-pharmacological interventions that can be used as alternatives to opioids for back pain. These topics will be communicated using a 10-minute video designed specifically for the trial and also direct discussion between the GP and trial staff member. Every six months (until the recruitment target for each practice is met), researchers will schedule site visits involving a refresher training video summarising key messages on opioid stewardship and best practice management of back pain. Live online visits will be permitted in exceptional circumstances where face-to-face visits are not possible. Patient-participants will be provided with a Consumer Medicines Information (CMI) leaflet for the opioid medicine(s) prescribed at the enrolment visit either electronically or via post and will be advised to discuss any queries or concerns regarding the CMI leaflet with their doctor or pharmacist. This will be determined during the baseline follow-up between the researcher and the patient-participant and provided by the study team. The CMI leaflet is a readily available resource and can be accessed via the following link- "https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/consumer-medicines-information-cmi". GPs will additionally be given access to the publicly available NPS opioid tapering algorithm. The heat wraps are single use products intended to provide pain relief for people with low back pain. Patient-participants will be advised on the correct and safe use of heat wraps by the study GPs and study team. Patient-participants will be advised to wear these for 6-8 hours during the day and to have a 1-day break after 3 consecutive days of use. Patients may choose to use, or not use the heat wraps. A heat wrap diary will be used to document use. Note: The study will also schedule monthly follow-up calls with the study GPs to discuss trial progress, as well as 3 monthly site visits until the study achieves its recruitment target. The site visits will involve the review of trial documents and provide study support. Where required, GPs will be provided an additional supply of study materials (e.g., heat wraps, screening forms, etc). Live online visits will be permitted in exceptional circumstances where face-to-face visits are not possible.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusions • Patient-participants greater than or equal to 18 years • Low back pain of any duration at the time of presentation • Has been prescribed an opioid analgesic for their low back pain by the participating GP within the past month • Sufficient understanding of English to complete questionnaires, or translation available. • Holds an Australian Medicare card number (for data linkage purposes). • Willingness to give written informed consent. GP Inclusions: * Consults with patients who have LBP • Has no prescribing restrictions, that is, eligible to prescribe an opioid analgesic (including schedule 8 opioid analgesics). * Consent to researchers gaining access to their prescribing data General Practice Inclusions * Has at least one practicing GP registered with the Australian Health Practitioner Regulation Agency.
Exclusion criteria
Patient Exclusions: • Be engaged in an opioid tapering regimen at the time of enrolment into the study i.e. have already begun to reduce their opioid medicine within the past month • Be actively treated for cancer, or receiving palliative treatment General Practice Exclusions: • Participating GP at that practice have received an education visit by any organisation on judicious opioid prescribing in the previous 12 months
Outcome results
None listed