Antipsychotic Polypharmacy: Prevalence, Background and Consequences - Full Text View

Sponsors and Collaborators:	Glostrup University Hospital,Copenhagen National Board of Health, Denmark
Information provided by:	Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:	NCT00541398

Purpose

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.

Condition	Intervention
Schizophrenia	Behavioral: Implementation of guideline

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment
Official Title:	Antipsychotic Polypharmacy: Prevalence, Background and Consequences

Further study details as provided by Glostrup University Hospital,Copenhagen:

Primary Outcome Measures:

Prevalence of antipsychotic polypharmacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	222
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Behavioral: Implementation of guideline Outreach visits with interactive education for health staff
B: No Intervention

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541398

Locations

Denmark
CNSR
Glostrup, Denmark, 2600

Sponsors and Collaborators

Glostrup University Hospital,Copenhagen

National Board of Health, Denmark

Investigators

Study Director:

Birte Glenthøj, Professor

University of Copenhagen

More Information

Responsible Party:	Center for Neuropsychiatric Schizophrenia Research ( Professor Birte Glenthøj )
Study ID Numbers:	0-204-03-9-9
Study First Received:	October 9, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00541398
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital,Copenhagen:

Antipsychotic polypharmacy.
Schizophrenia.
Implementation of clinical guidelines.

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 14, 2009