Cargando…

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

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 diagno...

Descripción completa

Detalles Bibliográficos
Autores principales: Geiger, Isabel, Kammerlander, Christian, Höfer, Christine, Volland, Ruth, Trinemeier, Jörg, Henschelchen, Martina, Friess, Thomas, Böcker, Wolfgang, Sundmacher, Leonie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801785/
https://www.ncbi.nlm.nih.gov/pubmed/33435869
http://dx.doi.org/10.1186/s12877-020-01966-1
_version_ 1783635650417786880
author Geiger, Isabel
Kammerlander, Christian
Höfer, Christine
Volland, Ruth
Trinemeier, Jörg
Henschelchen, Martina
Friess, Thomas
Böcker, Wolfgang
Sundmacher, Leonie
author_facet Geiger, Isabel
Kammerlander, Christian
Höfer, Christine
Volland, Ruth
Trinemeier, Jörg
Henschelchen, Martina
Friess, Thomas
Böcker, Wolfgang
Sundmacher, Leonie
author_sort Geiger, Isabel
collection PubMed
description 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
format Online
Article
Text
id pubmed-7801785
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-78017852021-01-12 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 Geiger, Isabel Kammerlander, Christian Höfer, Christine Volland, Ruth Trinemeier, Jörg Henschelchen, Martina Friess, Thomas Böcker, Wolfgang Sundmacher, Leonie BMC Geriatr Study Protocol 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 BioMed Central 2021-01-12 /pmc/articles/PMC7801785/ /pubmed/33435869 http://dx.doi.org/10.1186/s12877-020-01966-1 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Geiger, Isabel
Kammerlander, Christian
Höfer, Christine
Volland, Ruth
Trinemeier, Jörg
Henschelchen, Martina
Friess, Thomas
Böcker, Wolfgang
Sundmacher, Leonie
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801785/
https://www.ncbi.nlm.nih.gov/pubmed/33435869
http://dx.doi.org/10.1186/s12877-020-01966-1
work_keys_str_mv AT geigerisabel implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT kammerlanderchristian implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT hoferchristine implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT vollandruth implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT trinemeierjorg implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT henschelchenmartina implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT friessthomas implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT bockerwolfgang implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare
AT sundmacherleonie implementationofanintegratedcareprogrammetoavoidfragilityfracturesofthehipinolderadultsin18bavarianhospitalsstudyprotocolfortheclusterrandomisedcontrolledfractureliaisonserviceflscare