Trial document




drksid header

  DRKS00015280

Trial Description

start of 1:1-Block title

Title

Evaluation Pediatric-Centered Integrated Care AOK Junior

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

Trial Acronym

EPIVA

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

URL of the Trial

https://innovationsfonds.g-ba.de/projekte/versorgungsforschung/epiva-evaluation-paediatriezentrierte-integrierte-versorgung-aok-junior.121

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

Brief Summary in Lay Language

The selective contract for the pediatric-centered integrated care ("AOK-Junior") complements the regular care coverage for insured persons up to the age of 18 with the three additional examinations U10, U11 and J2 and other benefit modules, such as: Ophthalmological screening, pulmonary and skin check-up or dental health. The pediatrician acts as a pilot and coordinates pediatric, general and specialist care. The focus of the selective contract is on prevention. Furthermore, the aim of this contract is not only to preserve the health of children and adolescents but also to prevent, recognize and treat illness in good time. The study examines whether the selective contract enables paediatricians to recognize childhood and adolescent illnesses. In addition, the satisfaction of program participants and healthcare providers is assessed. The study includes an analysis of factors that promote or hinder the implementation of the selective contract. EPIVA also considers the cost-effectiveness of the selective contract.
The results are used to derive recommendations for further development of the selective contract and to further improve the care of children and adolescents.

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

Brief Summary in Scientific Language

The AOK Junior care program currently involves around 560 pediatricians and around 63,000 children and adolescents. The evaluation examines the effectiveness of complex intervention at the levels of structural, process and outcome quality. The evaluation of cost-effectiveness is based on a health economic evaluation. In addition to the collection of qualitative and quantitative primary data from participating and non-participating children and adolescents as well as pediatricians, routine data are used. The evaluation of the structure and process quality is carried out by a cross-sectional design. The quality of the results is evaluated in longitudinal section design based on secondary data. The evaluation results suggest indications for further development of the health care program. Recommendations derived from the evaluation provide a basis for future decisions and investments in the areas of health promotion and prevention.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015280
  •   2019/03/18
  •   [---]*
  •   yes
  •   Approved
  •   8029_BO_K_2018, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   01VSF17004  (Innovationsausschuss beim G-BA)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Incidence of chronic diseases, health-related quality of life.
  •   Cost-effectiveness of the prevention measure.
  •   Barriers and potentials of the intervention as well as the satisfaction of the target group as well as the healthcare providers involved.
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The arm 1 consists of a sample of AOK-Junior participating children and adolescents (intervention group children and adolescents). The study examines whether "AOK-Junior" enables paediatricians to recognize childhood and adolescent illnesses.
  •   The arm 2 consists of a sample of children and adolescents not participating in the selective contract (children and adolescents control group).
  •   The arm 3 consists of a sample of AOK junior participating pediatricians (intervention group pediatricians).
  •   The arm 4 consists of a sample of pediatricians (control group pediatricians).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Health-related quality of life (KIDSCREEN).

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

Secondary Outcome

Incidence of chronic diseases. Cost-effectiveness of the prevention measure. Barriers and potentials of the intervention as well as the satisfaction of the target group as well as the healthcare providers involved.

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/03/25
  •   1532
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Children and adolescents residing in the federal states of Berlin, Brandenburg or Mecklenburg-Vorpommern. Paediatricians based in the federal states of Berlin, Brandenburg or Mecklenburg-Vorpommern.

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

Exclusion Criteria

None.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • AOK Nordost – Die Gesundheitskasse, Versorgungsmanagement
    • Mr.  Dr.  Sebastian  Liersch 
    • Wilhelmstr. 1
    • 10963  Berlin
    • 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
    • Medizinische Hochschule Hannover, Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung
    • Mr.  Prof. Dr.  Christian  Krauth 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • 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
    • AOK Nordost – Die Gesundheitskasse, Versorgungsmanagement
    • Mr.  Dr.  Sebastian  Liersch 
    • Wilhelmstr. 1
    • 10963  Berlin
    • 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
    • Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA) - Innovationsfonds -
    • Wegelystraße 8
    • 10623  Berlin
    • 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.