Trial document





This trial has been registered retrospectively.
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  DRKS00014047

Trial Description

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Title

Mambo – Multimorbid People in Outpatient Care: Patient-Focused and demand based Healthcare Management.

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Trial Acronym

Mambo

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URL of the Trial

http://www.imvr.de/index.php?page=eMamBo

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Brief Summary in Lay Language

The aim of the project is the evaluation of the intervention. The intervention itself takes place at patients' direct living environment, by adding a monitoring and controlling assistant.

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Brief Summary in Scientific Language

An adequate and efficient treatment of patients who are in a complex, multimorbid situation requires a well-structured, informed and cross-indicated treatment. The MamBo care model therefore pursues a disease-spanning meta-strategy and establishes the necessary structures.
The intervention consists of the establishment of a care management. This will be established in the part of an already existing network of physicians. The care management is in charge of coordinating an additional specialist, the monitoring and controlling assistant (MoniKa). The MoniKas are working on a practice-overarching basis and taking over patient-oriented and coordinative tasks (e.g. house calls, patient training, coordination between general practitioners and specialists) that can be delegated by doctors. Furthermore, meetings on continuous improvement processes (CIP meetings) are held with the participating doctors on the initiative of the care management. In addition, a demand management (DM) is set up on the part of the health insurance company. Participating physicians and the care management can request anonymous data about the collective from the DM in order to identify patient-oriented needs.
The pilot project aims A) to improve the quality of care and the coordination of treatment of multimorbid patients in the Leverkusen region and B) to relief physicians in the patient care. The overarching objective of this study is to evaluate the care model MamBo according its implementation process and effectiveness. For this a formative and summative evaluation will be conducted. While the formative evaluation aims to identify beneficial and inhibiting factors of the implementation, the aim of the summative evaluation is to examine whether the care model is superior to regular care. Thus effectiveness and implementability as well as its sustainability will be examined.

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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

  •   DRKS00014047
  •   2019/06/28
  •   [---]*
  •   yes
  •   Approved
  •   17-327, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Multimorbidity
  •   Polypharmacy
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Interventions/Observational Groups

  •   Physicians who are part of the cooperating physicians network (RGL) will be enrolled in the project by the project-partners within this network. These doctors in turn enrol patients with at least three chronic diseases and who would like to participate in the project. They will be cared disease-spanning and, if necessary, receive the intervention by the MoniKa.
    The patients are continuously evaluated as part of the summative evaluation. With their consent, they receive a postal survey at two (t0&t1) measurement times.The t0 survey measures the status before the intervention or rather at their point of enrolment. The t1 survey measures the status after one year of intervention. In order to increase the pre-post comparison, patients enrolled from November 2019 will have a shortened intervention period of 6 months. The patient’s questionnaire partly consists standard scales: WHO 5-items Well-being Scale, Patient Assessment of Chronic Illness Care (PACIC) shortened form, Health Literacy-HLS-16 scale, Medication Adherence Rating Scale (MARS), Brief Social Support Scale (BS6)
    The participating physicians and practice staff will also be asked to take part in such a postal survey (t0&t1). Survyed are: expectations of the care model (t0) or rather the fulfilment of expectations (t1), practice characteristics (e.g. number of MFAs, joint practice/single practice), process data (e.g. work load, information procurement, patient safety)
    Physicians and the MoniKas will participate in focus groups and those responsible for the care and demand management are interviewed individually in order to identify inhibiting and promoting factors for the implementability of the structures.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   III
  •   [---]*
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Primary Outcome

The overall objective of this study is to evaluate the MamBo project in terms of implementation process and effectiveness. The goal of the formative evaluation is to identify the factors that support and inhibit the implementation.
The aim of the summative evaluation is to examine whether the care model is superior to regular care. Effectiveness and implementability are examined.

When and how: continuous postal surveys of patients, doctors and practice staff, annual focus groups with MoniKas and doctors and interviews with care management and demand management.

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Secondary Outcome

Relief for doctors and reduction of the costs of care for multimorbid patients (efficiency).

When and how:
(A)continuous postal survey of physicians

(B)Analysis of secondary health insurance data (claim data) at the end of the intervention: A cohort study will be conducted, in which multimorbid patients participating in MamBo as intervention group will be compared with multimorbid patients not participating in MamBo (control group). The comparison populations will be formed according to the Propensity Score Matching (PSM) method from data of the cooperating insurance company.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/03/30
  •   2615
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

at least 3 chronical conditions.

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Exclusion Criteria

less then 3 chronical conditions.
Excluding Cancer and psychical disorders.

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Addresses

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    • IMVR - Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät
    • Mr.  Prof. Dr.   Holger   Pfaff 
    • Eupener Strasse 129
    • 50933   Köln
    • Germany
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    • pronova BKK
    • Horst-Henning-Platz 1
    • 51373  Leverkusen
    • Germany
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    •   0214 322961000
    •   [---]*
    •   [---]*
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    • Regionales Gesundheitsnetz Leverkusen eG (RGL)
    • Bruchhauser Str. 30
    • 51381  Leverkusen
    • Germany
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    •   +49 2171 36368-0
    •   +49 2171 36368-19
    •   [---]*
    •   [---]*
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    • IMVR - Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft der
    • Mr.  M.Sc.  Ibrahim  Demirer 
    • Eupenerstr 129
    • 50933  Köln
    • Germany
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    • Regionales Gesundheitsnetz Leverkusen eG
    • Ms.  Nicole  Balke 
    • Bruchhauser Straße 30
    • 51381  Leverkusen
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Gutenbergstraße 13/ Postfach 120606
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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