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Tytuł:
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Implementation of an integrated care programme to avoid fragility fractures of the hip in older adults in 18 Bavarian hospitals - study protocol for the cluster-randomised controlled fracture liaison service FLS-CARE.
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Autorzy:
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Geiger I; Department of Health Services Management at LMU (LMU-HSM), Munich, Germany. .
Kammerlander C; Department of General, Trauma and Reconstructive Surgery, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.
Höfer C; AUC - Academy for Trauma Surgery GmbH, Munich, Cologne, Germany.
Volland R; AUC - Academy for Trauma Surgery GmbH, Munich, Cologne, Germany.
Trinemeier J; PVM Versorgungsmanagement GmbH, Speyer, Germany.
Henschelchen M; Department of Health Services Management at LMU (LMU-HSM), Munich, Germany.
Friess T; Department of Health Services Management at LMU (LMU-HSM), Munich, Germany.
Böcker W; Department of Health Services Management at LMU (LMU-HSM), Munich, Germany.
Sundmacher L; Chair of Health Economics, Technical University of Munich, Munich, Germany.
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Corporate Authors:
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FLS-CARE study group
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Źródło:
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BMC geriatrics [BMC Geriatr] 2021 Jan 12; Vol. 21 (1), pp. 43. Date of Electronic Publication: 2021 Jan 12.
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Typ publikacji:
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Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Original Publication: London : BioMed Central, [2001]-
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MeSH Terms:
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Delivery of Health Care, Integrated*
Osteoporotic Fractures*/epidemiology
Osteoporotic Fractures*/prevention & control
Activities of Daily Living ; Aged ; Germany/epidemiology ; Hospitals ; Humans ; Randomized Controlled Trials as Topic ; Secondary Prevention
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References:
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Osteoporos Int. 2016 Oct;27(10):2967-78. (PMID: 27172934)
Osteoporos Int. 2018 Jun;29(6):1227-1242. (PMID: 29460102)
BMJ. 2015 Mar 19;350:h1258. (PMID: 25791983)
BMC Musculoskelet Disord. 2014 Jun 26;15:219. (PMID: 24965132)
Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7. (PMID: 15365697)
Eur J Trauma Emerg Surg. 2016 Oct;42(5):559-564. (PMID: 27458065)
Osteoporos Int. 2015 Nov;26(11):2579-85. (PMID: 26048675)
Pharmacoeconomics. 2018 Jun;36(6):663-674. (PMID: 29460066)
BMC Med Res Methodol. 2011 Jun 30;11:102. (PMID: 21718530)
Osteoporos Int. 2017 Mar;28(3):775-780. (PMID: 28028554)
J Clin Epidemiol. 2014 May;67(5):527-37. (PMID: 24698296)
Dtsch Arztebl Int. 2013 Jan;110(4):52-7. (PMID: 23413388)
Osteoporos Int. 2004 Mar;15(3):175-9. (PMID: 14691617)
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Grant Information:
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01NVF18012 International German Federal Joint Committee (GBA)
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Contributed Indexing:
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Investigator: U Andrae; C Stäudel; HJ Andress; T Liese; M Behnke; M Stojanovic; U Brunner; S Schreiber; G Gradl; B Fürst; S Grote; C Schmid; S Grüninger; S Wicklein; T Lewens; K Gelse; T Löffler; M Bendiks; RH Meffert; B Schmitz; C Neuerburg; M Odenwald; M Thoma; P Schmitz; R Kretschmer; R Schupfner; E Pfeifer; I Solovyov; C Linder; U Stumpf; J Werther; A Fenwick; C Zeckey; J Ditto
Keywords: Fracture liaison service; Fragility fracture; Hip fracture; Integrated care; Osteoporosis; Secondary prevention
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Entry Date(s):
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Date Created: 20210113 Date Completed: 20210115 Latest Revision: 20220531
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Update Code:
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20240105
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PubMed Central ID:
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PMC7801785
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DOI:
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10.1186/s12877-020-01966-1
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PMID:
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33435869
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Background: The economic and public health burden of fragility fractures of the hip in Germany is high. The likelihood of requiring long-term care and the risk of suffering from a secondary fracture increases substantially after sustaining an initial fracture. Neither appropriate confirmatory diagnostics of the suspected underlying osteoporosis nor therapy, which are well-recognised approaches to reduce the burden of fragility fractures, are routinely initiated in the German healthcare system. Therefore, the aim of the study FLS-CARE is to evaluate whether a coordinated care programme can close the prevention gap for patients suffering from a fragility hip fracture through the implementation of systematic diagnostics, a falls prevention programme and guideline-adherent interventions based on the Fracture Liaison Services model.
Methods: The study is set up as a non-blinded, cluster-randomised, controlled trial with unequal cluster sizes. Allocation to intervention group (FLS-CARE) and control group (usual care) follows an allocation ratio of 1:1 using trauma centres as the unit of allocation. Sample size calculations resulted in a total of 1216 patients (608 patients per group distributed over 9 clusters) needed for the analysis. After informed consent, all participants are assessed directly at discharge, after 3 months, 12 months and 24 months. The primary outcome measure of the study is the secondary fracture rate 24 months after initial hip fracture. Secondary outcomes include differences in the number of falls, mortality, quality-adjusted life years, activities of daily living and mobility.
Discussion: This study is the first to assess the effectiveness and cost-effectiveness/utility of FLS implementation in Germany. Findings of the process evaluation will also shed light on potential barriers to the implementation of FLS in the context of the German healthcare system. Challenges for the study include the successful integration of the outpatient sector as well as the future course of the coronavirus pandemic in 2020 and its influence on the intervention.
Trial Registration: German Clinical Trial Register (DRKS) 00022237 , prospectively registered 2020-07-09.
