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.

Moles, RJ; Perry, L; Naylor, JM; Center, J; Ebeling, P; Duque, G; Major, G; White, C; Yates, C; Jennings, M; Kotowicz, M; Tran, T; Bliuc, D; Si, L; Gibson, K; Basger, BJ; Bolton, P; Barnett, S; Hassett, G; Kelly, A; Bazarnik, B; Ezz, W; Luckie, K; Carter, SR

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.

Moles, RJ Perry, L

Naylor, JM Center, J Ebeling, P Duque, G Major, G White, C Yates, C Jennings, M Kotowicz, M Tran, T Bliuc, D Si, L Gibson, K Basger, BJ Bolton, P Barnett, S Hassett, G Kelly, A Bazarnik, B Ezz, W Luckie, K Carter, SR

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Publisher:: BMJ
Publication Type:: Journal Article
Citation:: BMJ Open, 2023, 13, (8), pp. e072050
Issue Date:: 2023-08-24

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Field	Value	Language
dc.contributor.author	Moles, RJ
dc.contributor.author	Perry, L https://orcid.org/0000-0002-8507-1283
dc.contributor.author	Naylor, JM
dc.contributor.author	Center, J
dc.contributor.author	Ebeling, P
dc.contributor.author	Duque, G
dc.contributor.author	Major, G
dc.contributor.author	White, C
dc.contributor.author	Yates, C
dc.contributor.author	Jennings, M
dc.contributor.author	Kotowicz, M
dc.contributor.author	Tran, T
dc.contributor.author	Bliuc, D
dc.contributor.author	Si, L
dc.contributor.author	Gibson, K
dc.contributor.author	Basger, BJ
dc.contributor.author	Bolton, P
dc.contributor.author	Barnett, S
dc.contributor.author	Hassett, G
dc.contributor.author	Kelly, A
dc.contributor.author	Bazarnik, B
dc.contributor.author	Ezz, W
dc.contributor.author	Luckie, K
dc.contributor.author	Carter, SR
dc.date.accessioned	2023-10-06T05:32:32Z
dc.date.available	2023-10-06T05:32:32Z
dc.date.issued	2023-08-24
dc.identifier.citation	BMJ Open, 2023, 13, (8), pp. e072050
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/172561
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2023-072050
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.classification	52 Psychology
dc.subject.mesh	Humans
dc.subject.mesh	Aged
dc.subject.mesh	Accidental Falls
dc.subject.mesh	Medication Therapy Management
dc.subject.mesh	Pharmacists
dc.subject.mesh	Osteoporosis
dc.subject.mesh	Cholinergic Antagonists
dc.subject.mesh	Hypnotics and Sedatives
dc.subject.mesh	Primary Health Care
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Osteoporosis
dc.subject.mesh	Cholinergic Antagonists
dc.subject.mesh	Hypnotics and Sedatives
dc.subject.mesh	Accidental Falls
dc.subject.mesh	Aged
dc.subject.mesh	Pharmacists
dc.subject.mesh	Primary Health Care
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Medication Therapy Management
dc.title	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.
dc.type	Journal Article
utslib.citation.volume	13
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Engineering and Information Technology
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Faculty of Engineering and Information Technology/School of Biomedical Engineering
utslib.copyright.status	open_access	*
dc.date.updated	2023-10-06T05:32:28Z
pubs.issue	8
pubs.publication-status	Published online
pubs.volume	13
utslib.citation.issue	8

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.

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http://hdl.handle.net/10453/172561