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
Gustavo Duque,
Lei Si,
Peter Ebeling,
Gabor Major,
Thach Tran,
Justine M Naylor,
Kathryn Gibson,
Matthew Jennings,
Ayano Kelly,
Geraldine Hassett,
Christopher White,
Rebekah Jane Moles,
Patrick Bolton,
Wafaa Ezz,
Lin Perry,
Benjamin Joseph Basger,
Stephen Barnett,
Dana Bliuc,
Christopher Yates,
Jacqueline Center,
Mark Kotowicz,
Barbara Bazarnik,
Kate Luckie,
Stephen Ross Carter
Affiliations
Gustavo Duque
2 Australian Institute for Musculoskeletal Science (AIMSS), St Albans, Victoria, Australia
Lei Si
Western Sydney University, Penrith South, New South Wales, Australia
Peter Ebeling
Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia
Gabor Major
Department of Rheumatology, Bone and Joint Centre, Royal Newcastle Centre, John Hunter Hospital, Newcastle, New South Wales, Australia
Thach Tran
1 Global and Women’s Health, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Justine M Naylor
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia
Kathryn Gibson
Ingham Research Institute, Sydney, Australia
Matthew Jennings
Physiotherapy, Liverpool Hospital, Liverpool, New South Wales, Australia
Ayano Kelly
College of Health and Medicine, Australian National University Medical School, Canberra, Australian Capital Territory, Australia
Geraldine Hassett
Ingham Institute, Liverpool, New South Wales, Australia
Christopher White
Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia
Rebekah Jane Moles
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Patrick Bolton
Public Health and Community Medicine, University of New South Wales, Randwick, New South Wales, Australia
Wafaa Ezz
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Lin Perry
School of Public Health, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia
Benjamin Joseph Basger
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Stephen Barnett
Graduate School of Medicine, University of Wollongong, Wollongong, New South Wales, Australia
Dana Bliuc
Department of Osteoporosis and Bone Biology, Garvan Institute of Medical Research, Sydney, New South Wales, Australia
Christopher Yates
senior lecturer in mathematical biology
Jacqueline Center
Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia
Mark Kotowicz
Epi-Centre for Healthy Ageing, Deakin University - Geelong Campus at Waurn Ponds, Geelong, Victoria, Australia
Barbara Bazarnik
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Kate Luckie
Musculoskeletal Clinical Group, University of New South Wales, Sydney, New South Wales, Australia
Stephen Ross Carter
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
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.
