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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

Organizational Data

DRKS-ID:
DRKS00022237
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-07-09
Last update in DRKS:
2022-02-07
Registration type:
Prospective

Acronym/abbreviation of the study

FLS Care

URL of the study

http://www.fls-care.de

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.

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.

Health condition or problem studied

ICD10:
M81.9 - Osteoporosis, unspecified
ICD10:
S72.0 - Fracture of neck of femur
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Intervention Group with implementation FLS Care
Arm 2:
Control group with common treatment and therapy

Endpoints

Primary outcome:
refracture rate in follow up of two years
Secondary outcome:
Number of falls, mortality, quality-adjusted life years, activities of daily living, mobility at follow up of two years

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Bayern

Recruitment period and number of participants

Planned study start date:
2020-10-01
Actual study start date:
2021-06-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1216
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
50 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Women> 50, men> 60, low-energy trauma, femoral neck fracture, insured patients with participating health insurance companies

Exclusion Criteria

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

Addresses

Primary Sponsor

Klinik für Allgemeine- Unfall und Wiederherstellungschirurgie
Univ.-Prof. Prof.Wolfgang Prof.Boecker
Marchioninistraße 15
81377 Muenchen
Germany
Telephone:
+49440073500
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemeine- Unfall und Wiederherstellungschirurgie
Univ.-Prof. Wolfgang Böcker
Marchioninistr. 15
81377 München
Germany
Telephone:
+49440073500
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/Klinik-fuer-Allgemeine-Unfall-und-Wiederherstellungschirurgie/de/index.html

Contact for Public Queries

Klinik für Allgemeine -Unfall und Wiederherstellungschirurgie
Dr. med. Martina Henschelchen
Marchioninistr. 15
81377 München
Germany
Telephone:
+49440073500
Fax:
No Entry
Contact per E-Mail
URL:
http://www.fls-care.de

Principal Investigator

Klinik für Allgemeine- Unfall und Wiederherstellungschirurgie
Univ.-Prof. Wolfgang Böcker
Marchioninistr. 15
81377 München
Germany
Telephone:
+49440073500
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/Klinik-fuer-Allgemeine-Unfall-und-Wiederherstellungschirurgie/de/index.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Gemeinsamer Bundesausschuss
Gutenbergstr. 13
10587 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-01-15
Ethics committee number:
19-2016
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-04-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry