Trial document




This trial has been registered retrospectively.
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  DRKS00017548

Trial Description

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Title

Evaluation of the outpatient healthcare contract of the AOK for patients with orthopaedic diseases according to §73c SGB V in Baden-Wurttemberg

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Trial Acronym

EVAL FAV Ortho

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URL of the Trial

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Brief Summary in Lay Language

German health policy legislation (§73c SGB V) allow contracts between Statutory Health Insurances (SHI) and outpatient physicians (general practitioners and specialists) to enable special and innovative programs of healthcare. To optimize healthcare for patients with orthopaedic diseases, an applicable contract was concluded between the largest SHI in Baden-Wurttemberg (AOK Baden-Wurttemberg) and SHI-accredited orthopaedic surgeons. The contract entails different quality arrangements and incentives.
The aim of this scientific evaluation is to study the effects of this contract on healthcare quality and costs. It will compare patients participating in the program with patients treated in the regular healthcare setting.

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Brief Summary in Scientific Language

German health policy legislation (§73c SGB V) allow contracts between Social Health Insurances (SHI) and outpatient physicians (general practitioners and specialists) to enable special and innovative programs of healthcare. To optimize healthcare for patients with orthopaedic diseases, such a contract was concluded between the largest SHI in Baden-Wurttemberg (AOK Baden-Wurttemberg) and SHI-Accredited orthopaedic surgeons. The contract entails different quality arrangements and incentives.
For evaluation of the contract, a cohort of patients participating in the program (intervention group) will be compared to a cohort of patients in regular healthcare (control group). Healthcare within the program is conceptualized as a complex intervention* including aspects of managed and integrated care. Quality measures include specific requirements for participating orthopaedic surgeons, targeted improvement of evidence-based pharmacotherapy and treatment according to current practice guidelines. Furthermore interaction of primary care and specialist care is being optimized.
The study design is a retrospective analysis (descriptive and multivariate statistics) of insurance claims data of the AOK Baden-Wuerttemberg. Indicators for medical treatment quality and outcomes as well as health economic analysis will be conducted.
* The study is a retrospective evaluation of the program, no intervention within the study itself will be conducted.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017548
  •   2019/08/02
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  •   yes
  •   Approved
  •   338/18, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   nonspecific back pain, lower back pain, specific back pain, osteoporosis
  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Patients enrolled in the Orthopaedic HealthCare program:
    Routine data from AOK insurants with orthopaedic diseases in 2014 to 2017 enrolled in the Orthopaedic Healthcare Program is analyzed in regard to HealthCare Quality and Health economic aspects.
  •   Patients enrolled in regular healthcare
    Routine data from AOK insurants with orthopaedic diseases in 2014 to 2017 in regular healthcare is analyzed in regard to healthcare quality and health economic aspects.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Multiple indicators for medical care quality (claim of insurance services, pharmacotherapy, clinical outcomes), aspects of health economics. Outcome analysis for 2016 and 2017.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/12/10
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  •   Multicenter trial
  •   National
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Inclusion Criteria

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

The cohort enrolled in the programme is condsidered the "interventional group" and patients treated by regular GPs and Orthopaedic surgeons as control group. All patients were treated for orthopaedic diseases. The evaluation is based on retrospective routine data analysis of data from AOK insurants from 2014 to 2017.

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Exclusion Criteria

Interruption of enrollment in AOK or Orthopaedic contract insurance (except cases of death 2015-2017),
under-aged patients on Jan 1st 2015,
patients enrolled in another health care program,
zip code of patient or doctor not within Baden-Württemberg

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Addresses

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    • Institut für Allgemeinmedizin der Goethe-Universität Frankfurt
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Institut für Allgemeinmedizin Goethe-Universität Frankfurt am Main
    • Ms.  Dr. med.  Angelina  Müller 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Institut für Allgemeinmedizin der Goethe-Universität Frankfurt
    • Ms.  Dr. med.  Angelina  Müller 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/08/01
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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.