Trial document





This trial has been registered retrospectively.
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  DRKS00013489

Trial Description

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Title

Implementing Routinecare for Children and Adolescents with ADHD According to the Guidelines – Barriers and Effects

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Trial Acronym

IMLEIV

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URL of the Trial

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Brief Summary in Lay Language

The stepped study investigates the implementation of guideline-compliant treatment of children and adolescents with (risk of) ADHD, its barriers in clinical practice and the effects of workshops and provision of material in increasing guideline-compliance.
Information on guidelines as well as corresponding evidence based materials (questionnaires, psychoeducational scripts, documentation-aides) can be developed / provided.
1. First, guideline-compliance in routine care of children and adolescents with ADHD is to be recorded in provider’s self-assessment throughout Germany, as well as their attitudes to the valid guidelines and perceived barriers (interview).
2. Contents of the routine care of consecutively (within 3 months) included patients are documented over 6 months and changes are assessed pre and post this interval by parents, providers and the patients themselves via questionnaires.
3. After completion of the last measurement in patients of a provider training of guideline-compliant care of ADHD in children and adolescents is implemented and material is provided.
4. Contents of the routine care of additionally, consecutively (in a renewed period of 3 months) included patients are documented over 6 months and changes are assessed pre and post this interval by parents, providers and the patients themselves via questionnaires.
The study includes of all types of providers who deliver care to children and adolescents with (suspected) ADHD within the system of statutory health insurance in Germany. These included pediatricians and child and adolescent psychiatrists as well as psychotherapists for children and adolescents who work either in private practice or in institutions (social pediatric centres, outpatient units or clinics for child and adolescent psychiatry or schools for child and adolescent psychotherapy (BT).
The study includes patients aged 6 to 18 years with a first time (at least a suspected) diagnosis of ADHD by this provider within the 3 months inclusion interval. In those patients a mental disability or autism spectrum disorder can be excluded and no indication for a stationary treatment is present.
The study is intended to provide a general description of the guideline-compliance of the care of children and adolescents with ADHD and the barriers perceived by the reporting providers.in that process taking their attitudes into account. These findings are to be deepened by the description of the guideline-compliance within the care of specific patients. In addition, the aim is to assess the extent to which guidelines-compliance and changes during the process of care can be increased by training and provision of guideline-oriented material.
Differences between the general self-assessment of guideline-orientation and the one within specific care processes can be assumed as well as the achievement of an increase in these and the changes over the period of documentation by the implementation of Information and material described above.

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Brief Summary in Scientific Language

Main purpose
Investigating the implementation of guideline-oriented treatment of children and adolescents with (risk of) ADHD and its barriers in clinical practice.
Background
Various professional associations in Germany have published clinical guidelines for this group for which the transfer into overall S3 guidelines for 2018 is foreseen. However, the degree of implementation of these guidelines in practice has not been investigated. Furthermore, it is not known to what extent provision of information, training and guideline-oriented materials can increase implementation.
Method
Review of the guidelines implementation and methods of their increase in clinical practice in a nationwide survey taking into account all the occupational groups involved and as well as their organizational forms, both by means of systematic surveying and documentation of specific treatment pathways and their changes.
Sub-Study 1
1. Nationwide survey of a reasonable number of representatives of all types of providers assessing the extent of the guideline-orientation of their routine care of children and adolescents with ADHD as well as their attitudes to the valid guidelines and perceived barriers preventing their implementation.
Sub-Study 2
2. Documentation of the contents of routine care (over 6 months) of newly registered patients consecutively included within 3 months, and assessment of changes in the parent-, provider- and self-report via questionnaires pre and post the of the 6-month measurement interval.
3. Implementation of training for guideline-adherent care of children and adolescents with ADHD and provision of materials for its support.
4. Documentation of the contents of care (over 6 months) of newly registered patients consecutively included within 3 months, and Assessment of changes in the parent-, provider- and self-report report via questionnaires pre and post the of the 6-month measurement interval..
In-/ Exclusion-Criteria
Sub-Study 1: Providers (pediatricians, child- and adolescent psychiatrists and child- and adolescent Psychotherapists, social pediatric centers, outpatient units of clinics for child- and adolescent psychiatry, Outpatient units of (VT-) training institutes for child- and adolescent psychotherapy) who provide their services within the framework of the public health insurance-system (GKV) in Germany.
Sub-Study 2: Patients aged 6 to 18 years with by this provider get a first time (at least suspicioned) diagnosis of ADHD, in which a mental disability or autism spectrum disorder as well as an indication for stationary treatment can be excluded by clinical judgement of the provider.
Objectives
The study is intended to provide a general description of the amount of implementation of the guidelines for the care of children and adolescents with ADHD and the perceived barriers, taking into account the attitudes of the reporting providers. These findings are to be deepened by describing the guideline-adherence in the process of care of specific patients. In addition, the aim is to assess the extent to which guideline-adherence as well as the achievable changes, through further training and the provision of guideline-oriented material, can be further increased.
Hypotheses
Sub-Study 1
1. Based on self-report of the care providers, reliable dimensions of the guideline-adherence, the attitudes to guidelines and the perceived barriers in their implementation can be aggregated.
2. There are correlations between these dimensions.
3. There are correlations between guideline-adherence and variables related to sociodemographic information and professional experience of the health care providers and the patients they are treating.
4. The dimensions differ between different groups of health care providers.
Sub-Study 2
1. The guideline-adherence of the individual patient's care in clinical practice can be quantified based on the health care provider’s documentation for the various sections of the care process.
2. Significant changes occur over the documented period with regard to symptoms (ADHD, comorbidity), quality of life, functional impairment, parental self-efficacy etc.
3. There is a correlation between guideline-adherence and change in the time period covered by the documentation.
4. Support of the implementation of guidelines in clinical practice can lead to an increase in guideline-adherence of care as well as the achievable changes over time.

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Organizational Data

  •   DRKS00013489
  •   2018/09/10
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  •   yes
  •   Approved
  •   13-372, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1205-6338 
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Health Condition or Problem studied

  •   F90 -  Hyperkinetic disorders
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Interventions/Observational Groups

  •   The study should provide a general description of the guideline-compliance in routine care of children and adolescents with ADHD and the perceived barriers, taking into account the attitudes of reporting providers. Representatives of all types of providers delivering care to children and adolescents with (suspected) ADHD within the system of statutory health insurance in Germany are included: Pediatricians, child and adolescent psychiatrists, psychotherapists for children and adolescents working either in private practice or in institutions as social pediatric centres, outpatient units of clinics for child and adolescent psychiatry or schools for child and adolescent psychotherapy [BT]).
    In a first step, guideline-compliance in routine care of children and adolescents with ADHD is to be recorded in provider’s self-assessment throughout Germany, as well as their attitudes to the valid guidelines and perceived barriers (interview).
    In a second phase of the study, this knowledge will be intensified by describing the guideline orientation of the care of specific patients. Patients aged 6 to 18 years with a first time (at least a suspected) diagnosis of ADHD by this provider within the 3 months inclusion interval are included if a mental disability or autism spectrum disorder can be excluded and no indication for a stationary treatment is present.The content of the routine care of these patients is documented by the provider over a period of 6 months, and changes in the parents' and providers' self-reports are recorded via questionnaires at the beginning and at the end of the measurement interval.
    In addition, the aim is to assess the extent to which guideline-compliance and changes during the process of care can be increased by training and provision of guideline-oriented material. For this purpose, an analog survey section with patient inclusion as described above is performed following the training.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

guideline-adherence & change in ADHD symptoms

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Secondary Outcome

Quality of life, functional impairment, parental self-efficacy, cooperation, satisfaction with care

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/08/19
  •   520
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Sub-Study 1:
health care provider (Pediatricians, child- and adolescent psychiatrists or psychotherapists, social-pediatric centers, outpatient units of clinics for child- and adolsecent psychiatry, outpatient Units of (VT-) training institutes for child- and adolescent psychotherapy)
Sub-Study 2:
children and adolescents aged 6 to 18 years with (at last a suspicioned) ADHS-diagnosis

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Exclusion Criteria

Subs-Study 1: care provided outside the framework of the public health insurance-system (GKV) in Germany
Subs-Study 2: mental disability or autism spectrum disorder, indication for stationary treatment

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Addresses

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    • Uniklinik Köln, Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie (AKIP)
    • Mr.  Univ.-Prof. Dr.  Manfred  Döpfner 
    • Pohligstraße 9
    • 50969  Köln
    • Germany
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    • Uniklinik Köln, Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters,
    • Ms.  PD Dr.  Julia  Plück 
    • Pohligstraße 9
    • 50969  Köln
    • Germany
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    • Uniklinik Köln, Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters,
    • Ms.  PD Dr.  Julia  Plück 
    • Pohligstraße 9
    • 50969  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesgesundheitsminiterium
    • Friedrichstraße 108
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/31
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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.