Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003351

Trial Description

start of 1:1-Block title

Title

Assertive Outreach for people with schizophrenia

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

Trial Acronym

[---]*

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

The German mental health system often lacks possibilities to provide an integrated and intensified outpatient care for people with severe mental illness. Assertive Outreach (AO), an approach for an intensive, community-based health care delivery, could help to overcome some of the deficits.
A model of AO treatment in which office based psychiatrists collaborate with ambulatory nursing services to provide a complex model of intensive homecare is currently being implemented in rural areas of Lower Saxony, Germany. The study aims to investigate the effectiveness and efficiency of this model for adult patients suffering from schizophrenia.
The main hypothesis is that schizophrenic patients receiving AO use significantly fewer days of hospital treatment than patients receiving treatment as usual. Further hypotheses concern the psychopathology, the level of functioning, the patient satisfaction with care and the health care costs.
Using a controlled “quasi”-randomised design the outcomes of patients receiving AO (intervention) are compared to those receiving treatment as usual (control). The controls are patients not eligible for AO because this treatment model is not reimbursed by their health insurance (“quasi”-randomisation).
Patients are recruited by the treating psychiatrists from May 2011 to March 2012. The observation period for each patient spans over 12 months with assessments every 3 months for health care utilisation parameters and every 6 months for all other parameters.
The findings from the study, independent on whether they support or reject the hypotheses, will be of great help for the further development of integration in mental health care in Germany.

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

Brief Summary in Scientific Language

The German mental health system often lacks possibilities to provide an integrated and intensified outpatient care for people with severe mental illness. Assertive Outreach (AO), an approach for an intensive, community-based health care delivery, could help to overcome some of the deficits.
A model of AO treatment in which office based psychiatrists collaborate with ambulatory nursing services to provide a complex model of intensive homecare is currently being implemented in rural areas of Lower Saxony, Germany. The study aims to investigate the effectiveness and efficiency of this model for adult patients suffering from schizophrenia (ICD 10: F20).
The main hypothesis is that schizophrenic patients receiving AO use significantly fewer days of hospital treatment than patients receiving treatment as usual. Further hypotheses concern the psychopathology, the level of functioning, the patient satisfaction with care and the health care costs.
Using a controlled “quasi”-randomised design the outcomes of patients receiving AO (intervention) are compared to those receiving treatment as usual (control). The controls are patients not eligible for AO because this treatment model is not reimbursed by their health insurance (“quasi”-randomisation).
Patients are recruited by the treating psychiatrists from May 2011 to March 2012. The observation period for each patient spans over 12 months with assessments every 3 months for health care utilisation parameters and every 6 months for all other parameters.
The findings from the study, independent on whether they support or reject the hypotheses, will be of great help for the further development of integration in mental health care in Germany.

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

Organizational Data

  •   DRKS00003351
  •   2011/11/29
  •   [---]*
  •   yes
  •   Approved
  •   Bo/03/2011, Ethikkommission bei der Ärztekammer Niedersachsen
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

  •   F20 -  Schizophrenia
  •   [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Assertive Outreach with a close collaboration between the psychiatrist and the mental health nurse (intervention)
  •   standard care (control)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Number of days spent in inpatient psychiatric care (measured with the Client Socio-demografic and Service Receipt Inventory CSSRI)

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

Secondary Outcome

Psychosocial functioning (patient: WHO-Disability Assessment Scale II 12-Item, physician: Global Assessment of Functioning (GAF))
Psychopathology (patient: 2 items from the Alcohol Use and Drug Use Scale, physician: Brief Psychiatric Rating Scale)
Life satisfaction (single item measure)
Patient satisfaction with care (Patient Assessment of Chronic Care (PACIC short version))
Direct and indirect costs (CSSRI)

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/05/03
  •   536
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

We include patients with a diagnosed schizophrenia (ICD-10: F20) and moderate or severe impairments in the level of functioning rated by the physician using the global assessment of functiong scale (GAF ≤ 60).

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

Exclusion Criteria

- medium or severe cognitive impairments or organic mental disorder
- insufficient language ability
- no capacity to give informed consent to the study participation
- patients who refuse assertive outreach

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

Addresses

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
    • Europäischer Fonds für regionale Entwicklung
    • Friedrichswall 1
    • 30159  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Land Niedersachsen
    • Friedrichswall 1
    • 30159  Hannover
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/09/05
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.