Trial document




drksid header

  DRKS00006337

Trial Description

start of 1:1-Block title

Title

Optimization of work-related medical rehabilitation-processes and identification of indicators of good practice.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

OptiPro

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In order to improve the quality and needs of rehabilitative care, the German Pension Insurance performs for people with specific work-related problems work-related medical rehabilitation (WMR), which is well-established, broadly investigated and has an evidence of benefit. Especially work-related medical rehabilitation measures offer considerably improved reintegration and participation opportunities in working life for persons with chronic disease or disability. There are numerous examples of good practice that have been made accessible to interested members. However in the heterogeneous field of rehabilitation services well-functioning concepts are not easily transferable between institutions. Especially not in the context of the necessary resources allocative decisions for the WMR effort and the partly different structural conditions. The rehabilitation centers are encouraged to submit WMR concepts and implement them. The problem with this process is, if the know-how for the drafting and implementation is lacking to meet qualitative standards and needs to treat adequately.
At this point the project starts: an integrated orthopedic WMR concept is to be developed, in which the end of the WMR treatment process (access/screening, diagnosis, treatment, transition/aftercare) is controlled by clinical treatment paths. The aim is to investigate the efficacy of this manualized approach. It will provide important clues about quality and standardization indicators that can be applied to other conditions. This is done with the good practice approach which enables a pragmatic, practical and flexible quality indicators system, which in addition to the common indicators – structure, process and outcome – especially focuses on the concept and the implementation process. The objective is to generate recommendations for action and implementation aids that are available to other rehabilitation facilities afterwards. The OptiPro-concept makes a contribution to the needs-focussed extension and development of WMR for patients with specific work-related problems as well as to the development of process standardization and WMR quality assurance.
The study consists of two parts: The integrated clinical WMR concept with the clinical treatment paths will be developed by using a formative evaluation (part A). To verify the efficacy, a summative evaluation (Part B) is carried out. Outcomes are the functional cabability in occupation, the health state, the subjective prognosis for gainful employment, the work ability and the return to work. The research design is a sequential control group design with four measuring times (pre, post, follow-up after 3 and 6 months). First, the control group will be charged. After the concept development and implementation, the intervention group is investigated. The evaluation is performed by qualitative and quantitative research methods.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006337
  •   2014/08/01
  •   [---]*
  •   yes
  •   Approved
  •   2013-485-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M00-M99 -  Diseases of the musculoskeletal system and connective tissue
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Control group: The study participants receive the conventional medical rehabilitation (usual care).
  •   Intervention group: The study participants are treated after the implementation of the work-related medical rehabilitation. This process is developed by the rehab-team of both clinics.
    The work-related medical rehabilitation is a multimodal treatment program that combines physical and functional job training, social and psychological support measures and work-related consultations to achieve improved occupational capability and integration of patients.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The functional capability in occupation (measuring instrument: IRES-3; Bührlen et al. 2005)
Measuring time: 3 and 6 months after discharge

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Health state (measuring instrument: EQ-5D); subjective prognosis for gainful employment (measuring instrument: SPE-scale); work ability (measuring instrument: work ability index)
Measuring time: 3 and 6 months after discharge

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2014/08/05
  •   454
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Orthopaedic Patients of the medical centers "Salzetalklinik" and "Klinik am Lietholz" (both in Bad Salzuflen, Germany), specific work-related problems (screening instrument: SIMBO-C), informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

acute disease and follow-up rehabilitation, cognitive impairments, insufficient German knowledge, insufficient physical cabability or motivation, patient is retired (old-age pension or unlimited EU pension)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Verein zur Förderung der Rehabilitationsforschung e. V., Norderney
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Rehabilitationsforschung Norderney, Abteilung Bad Salzuflen
    • Mr.  Philipp  Preßmann 
    • Alte Vlothoer Straße 1
    • 32105  Bad Salzuflen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Rehabilitationsforschung Norderney, Abteilung Bad Salzuflen
    • Mr.  Philipp  Preßmann 
    • Alte Vlothoer Straße 1
    • 32105  Bad Salzuflen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Verein zur Förderung der Rehabilitationsforschung e. V., Norderney
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.