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 Kelly; Barbara Bazarnik; Wafaa Ezz; Kate Luckie; Stephen Ross Carter

doi:10.1136/bmjopen-2023-072050

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

BMJ Open. 2023 Aug 24;13(8):e072050. doi: 10.1136/bmjopen-2023-072050.

Authors

Rebekah Jane Moles¹, Lin Perry², Justine M Naylor^{3

4}, Jacqueline Center⁵, Peter Ebeling⁶, Gustavo Duque⁷, Gabor Major^{8

9}, Christopher White^{10

11}, Christopher Yates¹², Matthew Jennings¹³, Mark Kotowicz^{14

15}, Thach Tran¹⁶, Dana Bliuc⁵, Lei Si¹⁷, Kathryn Gibson^{18

19}, Benjamin Joseph Basger¹, Patrick Bolton²⁰, Stephen Barnett²¹, Geraldine Hassett^{19

22}, Ayano Kelly¹⁸, Barbara Bazarnik¹, Wafaa Ezz¹, Kate Luckie²³, Stephen Ross Carter²⁴

Affiliations

¹ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
² School of Nursing and Midwifery, University of Technology Sydney Faculty of Health, Sydney, New South Wales, Australia.
³ Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.
⁴ Southwestern Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
⁵ Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.
⁶ Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.
⁷ Australian Institute for Musculoskeletal Science, The University of Melbourne, Melbourne, Victoria, Australia.
⁸ Department of Rheumatology, Bone and Joint Centre, Royal Newcastle Centre, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.
⁹ School of Medicine and Public Health, The University of Newcastle Faculty of Health and Medicine, Callaghan, New South Wales, Australia.
¹⁰ Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.
¹¹ Prince of Wales Hospital and Community Health Services, Randwick, New South Wales, Australia.
¹² Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.
¹³ Physiotherapy, Liverpool Hospital, Liverpool, New South Wales, Australia.
¹⁴ Epi-Centre for Healthy Ageing, Deakin University - Geelong Campus at Waurn Ponds, Geelong, Victoria, Australia.
¹⁵ Barwon Health, Geelong, Victoria, Australia.
¹⁶ Bone Biology Division, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.
¹⁷ The George Institute for Global Health, Newtown, New South Wales, Australia.
¹⁸ Liverpool Hospital, Liverpool, New South Wales, Australia.
¹⁹ Ingham Institute, Liverpool, New South Wales, Australia.
²⁰ Public Health and Community Medicine, University of New South Wales, Randwick, New South Wales, Australia.
²¹ GP Academic Unit, University of Wollongong, Wollongong, New South Wales, Australia.
²² Department of Rheumatology, Liverpool Hospital, Liverpool, New South Wales, Australia.
²³ Musculoskeletal Clinical Group, University of New South Wales, Sydney, New South Wales, Australia.
²⁴ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia [email protected].

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.

Keywords: CLINICAL PHARMACOLOGY; GERIATRIC MEDICINE; Musculoskeletal disorders.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Accidental Falls* / prevention & control
Aged
Cholinergic Antagonists
Humans
Hypnotics and Sedatives
Medication Therapy Management
Osteoporosis* / drug therapy
Pharmacists
Primary Health Care
Randomized Controlled Trials as Topic

Substances

Cholinergic Antagonists
Hypnotics and Sedatives

Associated data

ANZCTR/ACTRN12622000261718