Evidence map›Paper›PMID 33435869›Full record

ArticleBMC geriatrics2021

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.

Isabel Geiger, Christian Kammerlander, Christine Höfer, Ruth Volland, Jörg Trinemeier, Martina Henschelchen, Thomas Friess, FLS-CARE study group, Wolfgang Böcker, Leonie Sundmacher

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC geriatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Isabel GeigerDepartment of Health Services Management at LMU (LMU-HSM), Munich, Germany. geiger@bwl.lmu.de.ORCID 0000-0002-2303-2190
Christian KammerlanderDepartment of General, Trauma and Reconstructive Surgery, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.
Christine HöferAUC - Academy for Trauma Surgery GmbH, Munich, Cologne, Germany.
Ruth VollandAUC - Academy for Trauma Surgery GmbH, Munich, Cologne, Germany.
Jörg TrinemeierPVM Versorgungsmanagement GmbH, Speyer, Germany.
Martina HenschelchenDepartment of Health Services Management at LMU (LMU-HSM), Munich, Germany.
Thomas FriessDepartment of Health Services Management at LMU (LMU-HSM), Munich, Germany.
FLS-CARE study group
Wolfgang BöckerDepartment of Health Services Management at LMU (LMU-HSM), Munich, Germany.
Leonie SundmacherChair of Health Economics, Technical University of Munich, Munich, Germany.

Funding

German Federal Joint Committee (GBA) 01NVF18012
6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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 registrationGerman Clinical Trial Register (DRKS) 00022237 , prospectively registered 2020-07-09.

Indexed as

Delivery of Health Care, IntegratedOsteoporotic FracturesActivities of Daily LivingAgedGermanyHospitalsHumansRandomized Controlled Trials as TopicSecondary PreventionFracture liaison serviceFragility fractureHip fractureIntegrated careOsteoporosisSecondary prevention

Identifiers

PMID33435869
PMCPMC7801785

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.