Trial document



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  DRKS00014564

Trial Description

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Title

Case management after medical rehabilitation

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Trial Acronym

ORIENT

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URL of the Trial

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Brief Summary in Lay Language

Case management is an approach in order to ensure coordinated and collaborative support for people with comprehensive needs. The study accompanies the implementation of a case management for patients with mental disorders who completed a medical rehabilitation program. The case management approach aims at supporting the patients in returning to work. The study examines who is being reached by the case management approach, and which content is being delivered by the professionals and actually received by the patients. In addition, the study tests if case management clients experience better professional support, and if work participation of patients with a mental illness improves due to case management.

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Brief Summary in Scientific Language

Mental disorders affect work ability and work participation. In Germany, almost 74.000 people retired due to a mental illness in 2016. A common approach to support people with mental disorders in returning to work are multi-professional rehabilitation programs. These programs are mainly provided as inpatient programs. However, these programs seem to be insufficient to assure return to work in patients with more severe limitations and difficult environmental conditions.
Since February 1st 2017 the German Pension Insurance North is testing the implementation of a case management approach after participation in a rehabilitation program. We define case management as an approach in order to ensure coordinated and collaborative support for people with comprehensive needs.
The formative evaluation seeks to examine the implementation of the case management approach and to develop recommendations for the selection of participants and the proper implementation of case management.
The study is using a mixed-methods approach. Data collection is realized through standardized questionnaires and qualitative interviews with case managers, patients and other professionals.
The primary outcome is the perceived professional support for returning to work after the rehabilitation. To achieve an unbiased estimation of the treatment effect, we will compare participants of the case management with similar persons who did not receive a case management (propensity score matching).

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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

  •   DRKS00014564
  •   2018/04/25
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  •   yes
  •   Approved
  •   18-035, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1211-7104 
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Health Condition or Problem studied

  •   F00-F99 -  Mental and behavioural disorders
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Interventions/Observational Groups

  •   People in study arm 1 (intervention) will be accompanied by a case manager who supports returning to work after the patients completed their rehabilitation program. The first encounter takes place within the rehabilitation clinic. The first appointment is shortly after the client is being discharged from the rehabilitation clinic. In most cases this meeting takes place at the clients’ home. At the beginning of the case management the case manager and the client discuss and develop the goals for the case management process. The case manager collects and documents the relevant deficiencies and resources for achieving these goals. The intervention is restricted to 12 weeks and a maximum of 15 hours for face-to-face meetings, telephone contact with the client as well as contacts with third parties with a personal or work related background. The case management can be extended but this needs a request by the case manager.
  •   People in study arm 2 (control condition) will receive no further support after medical rehabilitation.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the assessment of the perceived professional support for returning to work after the rehabilitation. The scale developed for this study includes 6 items (e.g. “I had a specific contact person, who provided support for my return to work.”, I had the feeling, that I wasn’t left to my own devises after the rehabilitation.”). The response format is a five-point scale (0 = „completely disagree“, 1 = “slightly disagree”, 2 = “somewhat agree”, 3 = “mostly agree”, 4 = “completely agree”) The total score ranges from 0 to 24 points.

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Secondary Outcome

The following secondary outcomes will be assessed by questionnaire at the end of rehabilitation and 6-month follow-up: self-rated work ability (Work Ability Score; 0 to 10 points), self-rated prognosis of employability (3-item scale; 0 to 3 points), Index to measure restrictions of participation (0 to 90 points), work self-efficacy (0 to 30 points), return to work at follow-up (“have you been working continuously within the last 4 weeks – without any sick leave?”)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/07
  •   384
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

We include patients who participated in a medical rehabilitation program which was approved by the German Pension Insurance North due to a mental disorder.

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Exclusion Criteria

We excluded patients with a granted vocational rehabilitation measure, patients with a general working capacity of less than three hours a day, patients who applied for or already receive a regular pension, and who receive a payment that is regularly paid until the commencement of a retirement pension (e.g. occupational pension)

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Addresses

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    • Deutsche Rentenversicherung Nord
    • Ms.  Dr.  Nathalie  Glaser-Möller 
    • Ziegelstraße 150
    • 23556  Lübeck
    • Germany
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    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
    • Ms.  Stella  Lemke 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Nord
    • Ziegelstraße 150
    • 23556  Lübeck
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/11/25
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Trial Publications, Results and other Documents

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