Antipsychotic Polypharmacy: Prevalence, Background and Consequences

NCT ID: NCT00541398

Last Updated: 2009-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Implementation of guideline

Intervention Type BEHAVIORAL

Outreach visits with interactive education for health staff

B

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Implementation of guideline

Outreach visits with interactive education for health staff

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Board of Health, Denmark

OTHER_GOV

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Center for Neuropsychiatric Schizophrenia Research

Principal Investigators

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Birte Glenthøj, Professor

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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CNSR

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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0-204-03-9-9

Identifier Type: -

Identifier Source: org_study_id

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