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

Not Applicable

Recruiting

• Conditions: iberal prescribing of opioids by GP; Liberal prescribing of opioids by GP; Public Health - Health service research

• Registration Number: ACTRN12622001505796
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-02
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 410

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
•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative opioid dispensed to patient-participants that was prescribed by study GPs: Using Services Australia Pharmaceutical Benefits Scheme (PBS) data, we will determine the cumulative dose of opioid medicines dispensed for patient-participants (in morphine milligram equivalent dose) that were prescribed by study GPs in the intervention vs control groups.[1 year post-enrolment]