Safer medicines To reduce falls and refractures for OsteoPorosis (#STOP): a study protocol for a randomised controlled trial of medical specialist-initiated pharmacist-led medication management reviews in primary care

Rebekah Jane Moles, Lin Perry, Justine M. Naylor, Jacqueline Center, Peter Ebeling, Gustavo Duque, Gabor Major, Christopher White, Christopher Yates, Matthew Jennings, Mark Kotowicz, Thach Tran, Dana Bliuc, Lei Si, Kathryn Gibson, Benjamin Joseph Basger, Patrick Bolton, Stephen Barnett, Geraldine Hassett, Ayano KellyBarbara Bazarnik, Wafaa Ezz, Kate Luckie, Stephen Ross Carter

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Abstract

Introduction Minimal trauma fractures (MTFs) often occur in older patients with osteoporosis and may be precipitated by falls risk-increasing drugs. One category of falls risk-increasing drugs of concern are those with sedative/anticholinergic properties. Collaborative medication management services such as Australia's Home Medicine Review (HMR) can reduce patients' intake of sedative/anticholinergics and improve continuity of care. This paper describes a protocol for an randomised controlled trial to determine the efficacy of an HMR service for patients who have sustained MTF. Method and analysis Eligible participants are as follows: ≥65 years of age, using ≥5 medicines including at least one falls risk-increasing drug, who have sustained an MTF and under treatment in one of eight Osteoporosis Refracture Prevention clinics in Australia. Consenting participants will be randomised to control (standard care) or intervention groups. For the intervention group, medical specialists will refer to a pharmacist for HMR focused on reducing falls risk predominately through making recommendations to reduce falls risk medicines, and adherence to antiosteoporosis medicines. Twelve months from treatment allocation, comparisons between groups will be made. The main outcome measure is participants' cumulative exposure to sedative and anticholinergics, using the Drug Burden Index. Secondary outcomes include medication adherence, emergency department visits, hospitalisations, falls and mortality. Economic evaluation will compare the intervention strategy with standard care. Ethics and dissemination Approval was obtained via the New South Wales Research Ethics and Governance Information System (approval number: 2021/ETH12003) with site-specific approvals granted through Human Research Ethics Committees for each research site. Study outcomes will be published in peer-reviewed journals. It will provide robust insight into effectiveness of a pharmacist-based intervention on medicine-related falls risk for patients with osteoporosis. We anticipate that this study will take 2 years to fully accrue including follow-up. Trial registration number ACTRN12622000261718.
Original languageEnglish
Article numbere072050
Pages (from-to)1-10
Number of pages10
JournalBMJ Open
Volume13
Issue number8
DOIs
Publication statusPublished - 24 Aug 2023
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Clinical pharmacology
  • Geriatric medicine
  • Musculoskeletal disorders

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