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AnteayerBMJ Open

SAGE (safer analgesia): a protocol for a pragmatic cluster randomised controlled trial to reduce the use of high-risk medicines in people with chronic back and/or neck pain

Por: Abdel Shaheed · C. · McLachlan · A. J. · Mathieson · S. · Ivers · R. · Clare · P. J. · Blyth · F. · Stanaway · F. · Degenhardt · L. · Gnjidic · D. · French · S. · Thompson · R. · Hilmer · S. · Pinheiro · M. · Machado · G. C. · Austin · T. · Gardner · T. · Sharma · S. · Bennett · A. · Boogs
Introduction

Chronic back and neck pain are commonly treated with opioid analgesics, gabapentinoids and benzodiazepines, despite their high-risk profile and potential limited efficacy. Deprescribing interventions (aimed at medicine reduction or cessation) have shown some effectiveness in reducing the use of these medications, but similar approaches tailored to individuals with complex chronic back and/or neck pain are lacking and urgently needed. This trial will evaluate the effect of the safer analgesia (SAGE) intervention (training of general practitioners (GPs) in deprescribing and support to deprescribe) on cessation and/or reduction of the target high-risk medicine (a benzodiazepine, gabapentinoid or opioid) for people with chronic back and/or neck pain.

Methods and analysis

SAGE is a pragmatic cluster randomised trial that will be conducted with at least 30 general practices in Australia randomly assigned in a 1:1 ratio to the SAGE intervention or no intervention (usual care control group). The SAGE intervention is a GP-facing intervention comprising (i) training for GPs in deprescribing and access to deprescribing resources and (ii) deprescribing support—to assist the deprescribing process for their patients, GPs can conduct a long GP consultation (20–40-min duration), refer to trained physiotherapists for the provision of psychologically informed physiotherapy sessions and provide alternate pain management options including heat wrap and diclofenac gel. A total of 320 adult patient-participants experiencing chronic back and/or neck pain (≥ 3 months duration) prescribed a target high-risk medicine (benzodiazepine, gabapentinoid or opioid) persistently for this pain will be recruited via participating general practices. The primary outcome is cessation of dispensation of the trial participant’s high-risk medicine (a benzodiazepine, gabapentinoid or opioid) prescribed by their trial GP. The primary time-point for the primary outcome will be 1-year post-enrolment with an observation window of the preceding 4 weeks. Secondary outcomes include self-reported outcomes such as pain, quality of life and adverse events. Analyses will follow an intention-to-treat approach with a nested economic evaluation and per-protocol analysis planned separately.

Ethics and dissemination

The study received approval from the University of Sydney Human Research Ethics Committee (2024/HE001706). The results will be disseminated via publication in a peer-reviewed scientific journal, presentation at conferences and media.

Trial registration number

ANZCTR: ACTRN12625000953437.

Effectiveness of a co-adapted virtual discharge education app on disease knowledge and health behaviours in patients following heart attack: a multicentre, randomised controlled trial protocol in Sydney, Australia

Por: Zhang · L. · Shi · W. · Zhao · E. · Hyun · K. K. · Zecchin · R. · Gao · Y. · Brunorio · L. · Stanaway · F. · Ellis · T. · Redfern · J. · Clark · R. · Du · H. · Gallagher · R.
Introduction

Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.

Methods and analysis

This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.

Ethics and dissemination

The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.

Trial registration number

ACTRN12624000408583.

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