RecruitingACTRN12622001505796

Clinical Observation, Management, and Function Of low back pain Relief Therapies (COMFORT)

Clinical Observation, Management, and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised trial evaluating an intervention to support GPs provide opioid stewardship to their patients with low back pain.


Sponsor

The University of Sydney

Enrollment

410 participants

Start Date

Sep 5, 2023

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Back pain is one of the most common reasons Australians visit their GP, but opioid pain medicines — despite being frequently prescribed — often do not work well for long-term back pain and carry real risks of dependence, overdose, and other harms. The COMFORT study is testing whether a structured approach to reducing opioid prescribing for low back pain, led by GP practice education visits and supported with alternative tools like heat wraps and patient information about opioid risks, leads to fewer opioid prescriptions and better outcomes. GP practices will be randomly assigned to receive the full opioid stewardship intervention or to continue with usual care. Patients enrolled in the study will complete questionnaires at regular intervals tracking their pain levels, disability, mental health, quality of life, and any hospitalisations or adverse events related to their pain medicines. The study will follow participants for one year. You may be eligible if you are 18 or older, have low back pain, and have been prescribed an opioid medicine for your back pain by your GP within the past month. You need to hold an Australian Medicare card and be willing to complete questionnaires. You would not be eligible if you are already in the process of tapering your opioids, or if you are receiving treatment for active cancer or palliative care.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

NSW, Australia

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ACTRN12622001505796