Trial document




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  DRKS00015755

Trial Description

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Title

DanA

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Trial Acronym

Delirium-intervention in the acute-geriatric Setting. A non-pharmacological team-based Approach.
Measurement for the early prevention, recognition and treatment of sudden confusion of older inpatients.

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A sudden state of confusion ("delirium") is common to patients undergoing hospital treatment. This state of confusion often remains undetected and can also be associated with severe consequences for older people. Various measures are available to prevent or treat sudden confusion. However, most of these have not been specifically tailored to the specific needs of older people. In addition, the way in which these interventions are provided by a health care team (consisting of physicians, nurses, and therapists) has not yet been sufficiently investigated. Although the current study data demonstrates that the quality of interprofessional collaboration has a significant impact on treatment quality, this so-called "team-based approach" has not been widely used to prevent or to treat sudden confusion. Therefore, in the DanA study, the team-based approach will be transfered into clinical practice with the aim to prevent sudden confusional states of older people or in case of existing confusional states to influence a favorable course of treatment.

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Brief Summary in Scientific Language

Delirium is a common, severe and often undiscovered syndrome that may be associated with serious consequences for those patients that affected, especially the group of acute-geriatric patients. The currently available intervention programs have not yet been sufficiently evaluated for this clientele. In addition, the way in which delirium interventions are provided by health care professionals has not been sufficiently investigated. As a result, team-based approaches in the context of delirium prevention and management are still not well established in clinical practice and therefore insufficiently investigated. However, the current study data indicates in general that an intensivied interprofessional collaboration and communication between different health care professionals can enhance the effectiveness of health services and the quality of care. According to this, it is hypothesized that intensified interprofessional collaboration, based on the team-based approach of a regular and systematic exchange will also contribute to optimized delirium care. Therefore, in the DanA study, the team-based approach will be transfered into clinical practice with the aim to prevent delirium and to decline prävalence and incidence, and in case of unavoidable deliria to influence a favorable course of treatment.

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Organizational Data

  •   DRKS00015755
  •   2019/03/06
  •   [---]*
  •   yes
  •   Approved
  •   2018-636N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F05.0 -  Delirium not superimposed on dementia, so described
  •   F05.1 -  Delirium superimposed on dementia
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Interventions/Observational Groups

  •   Pre-intervention group (control group) = measurement of prevalence and incidence of delirium (without Intervention)
  •   Intervention group = Measurement of the effect of a systematic, daily, interprofessional exchange on the prevalence and incidence of delirium.
    Within the framework of this exchange, any changes and signs that may indicate a delirium are discussed and the consequences of action derived from them for the individual case are coordinated on an interprofessional basis.
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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
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Aim: Further development of interprofessional teamwork. T0= before the intervention phase (03(2019); T1= after the intervention phase 11/2019 using the Assessment of Interprofessional Team Collaboration Scale (AITCS-II).

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Secondary Outcome

Collection of primary endpoints of delirium-incidence and prevalence by secondary analysis of routine clinical data of each included patient treated in acute-geriatric ward in the pre-intervention phase (01.10.2018-28.02.2019) and in the intervention phase (01.06.2019-31.10.2019).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/04/01
  •   407
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients aged 65 and over (with and without cognitive impairments/dementia); patients with and without delirium at admission, non-ethyltoxic genesis; acute geriatric treatment.

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Exclusion Criteria

Patients with severely impaired communication skills; estimated hospital stay less than 48 hours.

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Addresses

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    • UMM MannheimMedizinische Klinik IISektion Altersmedizin/Geriatrisches Zentrum
    • Mr.  PD Dr. med.  Heinrich  Burkhardt 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Netzwerk Alternsforschung (NAR) der Universität Heidelberg
    • Ms.  Claudia  Eckstein 
    • Bergheimerstr. 20
    • 69115  Heidelberg
    • Germany
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    • Universitätsmedizin Mannheim, II. Medizinische Universitätsklinik, Sektion Altersmedizin
    • Mr.  PD Dr. med.  Heinrich  Burkhardt-Studienleitung 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim, II Medizinische Universitätsklinik, Sektion Altersmedizin,
    • Ms.  Claudia  Eckstein 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • UMM MannheimMedizinische Klinik IISektion Altersmedizin/Geriatrisches Zentrum
    • Mr.  PD Dr. med.  Heinrich  Burkhardt 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Netzwerk Alternsforschung (NAR) der Universität Heidelberg
    • Ms.  Claudia  Eckstein 
    • Bergheimerstr. 20
    • 69115  Heidelberg
    • Germany
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    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
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Status

  •   Recruiting ongoing
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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.