دورية أكاديمية

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Moles RJ; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Perry L; School of Nursing and Midwifery, University of Technology Sydney Faculty of Health, Sydney, New South Wales, Australia., Naylor JM; Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Southwestern Clinical School, University of New South Wales, Sydney, New South Wales, Australia., Center J; Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia., Ebeling P; Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia., Duque G; Australian Institute for Musculoskeletal Science, The University of Melbourne, Melbourne, Victoria, Australia., Major G; Department of Rheumatology, Bone and Joint Centre, Royal Newcastle Centre, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.; School of Medicine and Public Health, The University of Newcastle Faculty of Health and Medicine, Callaghan, New South Wales, Australia., White C; Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.; Prince of Wales Hospital and Community Health Services, Randwick, New South Wales, Australia., Yates C; Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, Australia., Jennings M; Physiotherapy, Liverpool Hospital, Liverpool, New South Wales, Australia., Kotowicz M; Epi-Centre for Healthy Ageing, Deakin University - Geelong Campus at Waurn Ponds, Geelong, Victoria, Australia.; Barwon Health, Geelong, Victoria, Australia., Tran T; Bone Biology Division, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia., Bliuc D; Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia., Si L; The George Institute for Global Health, Newtown, New South Wales, Australia., Gibson K; Liverpool Hospital, Liverpool, New South Wales, Australia.; Ingham Institute, Liverpool, New South Wales, Australia., Basger BJ; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Bolton P; Public Health and Community Medicine, University of New South Wales, Randwick, New South Wales, Australia., Barnett S; GP Academic Unit, University of Wollongong, Wollongong, New South Wales, Australia., Hassett G; Ingham Institute, Liverpool, New South Wales, Australia.; Department of Rheumatology, Liverpool Hospital, Liverpool, New South Wales, Australia., Kelly A; Liverpool Hospital, Liverpool, New South Wales, Australia., Bazarnik B; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Ezz W; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Luckie K; Musculoskeletal Clinical Group, University of New South Wales, Sydney, New South Wales, Australia., Carter SR; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia stephen.carter@sydney.edu.au.
المصدر: BMJ open [BMJ Open] 2023 Aug 24; Vol. 13 (8), pp. e072050. Date of Electronic Publication: 2023 Aug 24.
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Accidental Falls*/prevention & control , Osteoporosis*/drug therapy, Humans ; Aged ; Medication Therapy Management ; Pharmacists ; Cholinergic Antagonists ; Hypnotics and Sedatives ; Primary Health Care ; Randomized Controlled Trials as Topic
مستخلص: 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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: CLINICAL PHARMACOLOGY; GERIATRIC MEDICINE; Musculoskeletal disorders
سلسلة جزيئية: ANZCTR ACTRN12622000261718
المشرفين على المادة: 0 (Cholinergic Antagonists)
0 (Hypnotics and Sedatives)
تواريخ الأحداث: Date Created: 20230824 Date Completed: 20230828 Latest Revision: 20230828
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC10450068
DOI: 10.1136/bmjopen-2023-072050
PMID: 37620274
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2023-072050