Antipsychotic Polypharmacy: Prevalence, Background and Consequences

Schizophrenia Clinical Trial

Official title:

Antipsychotic Polypharmacy: Prevalence, Background and Consequences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541398
• Other study ID #: 0-204-03-9-9
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: October 30, 2009
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Implementation of guideline
Outreach visits with interactive education for health staff

Locations

Country	Name	City	State
Denmark	CNSR	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	National Board of Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of antipsychotic polypharmacy		1 year	No
Secondary	Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.		1 year	No