Trial document




drksid header

  DRKS00004589

Trial Description

start of 1:1-Block title

Title

Health Services Research in care of very-low-birth-weight-infants in NICUs – The impact of human and organizational factors on performance.

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

Trial Acronym

HSR-NICU

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

URL of the Trial

http://www.hsr-nicu.de

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

Brief Summary in Lay Language

The possibilities in care of premature infants have been fast-paced the last years. In our research project we examine how premature care can further be improved throughout germany. Therefore, we analyze the relationship between the medical care itself, aspects of medical ethics and economic key figures. The following data is collected at more than 60 neonatal intensive care units throughout germany: medical data of premature babies, parents perspective, the way of thinking of physicians and nurses and organizational and cost data of the hospital.

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

Brief Summary in Scientific Language

Premature birth is the major cause of perinatal acquired disabilities and mortality. The care of very premature infants with a birth weight less than 1,500g is shaped by several factors. Since February 2012 the HSR-NICU project in the field of health services research in care of very low birth weight infants is funded by the Federal Ministry of Education and Research (BMBF). The project aims to analyze the question how and to what extent outcomes of premature births less than 1,500g will be influenced by human and organizational factors.
A pilot study with five german neonatal intensive care units showed that workload, staff attitudes and structural features are influencing the quality of premature care.
In the current multicenter study with over 60 NICUs relationships between working conditions, staff and parent satisfaction, economic and medical factors, goals and organisational procedures are analysed in an interdisciplinary cooperation between medicine, ethics, business administration and sociology.
The methods for data collection are staff and parent questionnaires, medical outcome data as well as general information of participating centres as e.g. processes, costs, structures, capacity, case severity and occupancy.
Results of the interdisciplinary and innovative research project are expected to contribute to the organizational structuring of NICUs and to the design of care structures and processes in the field of Neonatology. Aim is the development and implementation of measures of quality management and improvement in the area of neonatal care.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004589
  •   2013/05/15
  •   [---]*
  •   yes
  •   Approved
  •   12-228, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   P07 -  Disorders related to short gestation and low birth weight, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   1) Survey of medical quality indicators of included preterms by three-sided questionnaire about treatment and clinical course parameters after discharge from hospital
    2) parent questionnaires during the hospital stay and 12 month after discharge
    3) One-time staff questionnaires for medical and nursing staff
    4) survey of general structure information with a questionnaire for the head of neonatology and the responsible controller
    5) survey of staff deployment with a shift schedule booklet for nursing staff for a time period of 6 months
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Survey and analysis of medical quality indicators of included preterms by three-sided questionnaire about treatment and clinical course parameters after discharge from hospital; questionnaire is filled in by the study-responsible physician; only routine data ist collected



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

Secondary Outcome

One-time staff questionnaires for medical and nursing staff; parent questionnaires during the hospital stay and 12 month after discharge; daily staff fluctuation with a shift schedule booklet for the nursing staff during a time period of 6 month

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

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/05/01
  •   1775
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Newborns <1500g or outborns <1500g if transferral into Nicu takes place within the first 24 hours; birth between 01.05. and 31.10.2013; intensive primary care after birth/treatment in NICU in survey period; one parent speaks german or an interpreter is available;

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

Exclusion Criteria

see inclusion criteria

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität zu Köln
    • Mr.  Prof. Dr.  Ludwig  Kuntz 
    • Albertus-Magnus Platz
    • 50923  Köln
    • 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
    • Universität zu Köln
    • Mr.  Prof.  Ludwig  Kuntz 
    • Albertus-Magnus Platz
    • 50923  Köln
    • 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
    • Universität zu Köln
    • Mr.  Prof.  Ludwig  Kuntz 
    • Albertus-Magnus Platz
    • 50923  Köln
    • 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
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  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 complete, follow-up complete
  •   2015/12/31
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.