Trial document




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  DRKS00022237

Trial Description

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Title

Implementation of an integrated care programme to avoid fragility fractures in older adults in 18 Bavarian hospitals - study protocol for the cluster-randomised controlled fracture liaison service FLS-CARE

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Trial Acronym

FLS Care

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URL of the Trial

http://www.fls-care.de

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Brief Summary in Lay Language

The aim of the project is to avoid osteoporosis-related secondary fractures by establishing an integrated care structure that ensures differentiated diagnosis and treatment of osteoporosis.

In the 'FLS-CARE' (Fracture Liaison Services) project, a network of doctors, nurses and physiotherapists ensures that the clarification and therapy of osteoporosis started in the hospital is continued in the outpatient structure. A nurse coordinates the transfer of the patients. A fall prevention program including home visits is also carried out for osteoporosis therapy. A cross-sector IT platform supports the project. A total of 1,200 patients after hip fracture are to be included at 18 centers in Bavaria. If successful, 'FLS-CARE' can reduce the frequency of subsequent fractures and falls and thus lead to lower mortality and a higher quality of life for the patient, as well as lower treatment costs.

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Brief Summary in Scientific Language

Background:
The economic and public health burden of fragility fractures of the hip in Germany are 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 program 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 unit of allocation. Sample size calculations resulted in a total number of 1,216 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, the 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 furthermore shed light on potential barriers in 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 and its influence on the intervention.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022237
  •   2020/07/09
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  •   yes
  •   Approved
  •   19-2016, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   M81.9 -  Osteoporosis, unspecified
  •   S72.0 -  Fracture of neck of femur
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Interventions/Observational Groups

  •   Intervention Group with implementation FLS Care
  •   Control group with common treatment and therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
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Primary Outcome

refracture rate in follow up of two years

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Secondary Outcome

Number of falls, mortality, quality-adjusted life years, activities of daily living, mobility at follow up of two years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2020/10/01
  •   1216
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

Women> 50, men> 60, low-energy trauma, femoral neck fracture, insured patients with participating health insurance companies

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Exclusion Criteria

Women <50, men <60, cancer diagnosis, pre-existing immobility, private patient, dialysis

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Addresses

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    • Klinik für Allgemeine- Unfall und Wiederherstellungschirurgie
    • Univ.-Prof.  Prof.Wolfgang  Prof.Boecker 
    • Marchioninistraße 15
    • 81377  Muenchen
    • Germany
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    • Klinik für Allgemeine- Unfall und Wiederherstellungschirurgie
    • Mr.  Univ.-Prof.  Wolfgang  Böcker 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik für Allgemeine -Unfall und Wiederherstellungschirurgie
    • Ms.  Dr. med.  Martina  Henschelchen 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Gutenbergstr. 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.