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OpenTrials
Completed

NCT Number: NCT00541398

Antipsychotic Polypharmacy: Prevalence, Background and Consequences

The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNSR

Glostrup Municipality, 2600, Denmark

About this study

Several surveys have shown a high prevalence of antipsychotic polypharmacy (concomitant prescription of at least 2 different antipsychotics) among patients with schizophrenia even though international guidelines recommend monotherapy.

From register data areas with differences in the prevalence of antipsychotic polypharmacy will be identified. Two high prevalence areas will be randomized to either control or intervention area. In the intervention area an intensive educational intervention consisting of outreach visits with a multifaceted approach will be carried out with the duration of 1 year.

Differences in health staff related factors such as knowledge and attitude towards clinical guidelines will be assessed with a questionnaire before and after the intervention in the intervention area as well as in the low prevalence area at baseline.

Medical records data describing the use of antipsychotic polypharmacy will be collected. With register data health economic issues will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The intervention is not aimed directly to the patients but their health care providers.
  • Patients with schizophrenia (F2* diagnosis according to ICD-10) taking antipsychotic medication and their health care providers in the specified areas will enter the study:
  • The patients will enter with data from their medical record, register data and a few exploring interviews while the health staff will enter with their questionnaire data.

Treatment and study plan

Implementation of guideline

Behavioral

Outreach visits with interactive education for health staff

Primary outcomes

  1. Prevalence of antipsychotic polypharmacy

    Time frame: 1 year

Secondary outcomes

  1. Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • National Board of Health, Denmark

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 10, 2007
Registry last updated
Nov 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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