Antipsychotic Polypharmacy: Prevalence, Background and Consequences

• Sponsor: Glostrup University Hospital, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00541398
• Collaborator: National Board of Health, Denmark (Other)
• Enrollment: 222
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 10.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Implementation of guideline	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Antipsychotic Polypharmacy: Prevalence, Background and Consequences
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Behavioral: Implementation of guideline; Outreach visits with interactive education for health staff
No Intervention: B

Outcome Measures

Primary Outcome Measures

1. Prevalence of antipsychotic polypharmacy [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00541398
• Other Study ID Numbers: 0-204-03-9-9
• First Posted: Oct 10, 2007
• Last Update Posted: Nov 1, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Antipsychotic polypharmacy; Schizophrenia; Implementation of clinical guidelines
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Nov 1, 2009