Antipsychotic Polypharmacy: Prevalence, Background and Consequences

This study has been completed.
Sponsor:
Collaborator:
National Board of Health, Denmark
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00541398
First received: October 9, 2007
Last updated: October 30, 2009
Last verified: October 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Antipsychotic Polypharmacy: Prevalence, Background and Consequences

Resource links provided by NLM:


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
Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Behavioral: Implementation of guideline
Outreach visits with interactive education for health staff
No Intervention: B

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Professor Birte Glenthøj, Center for Neuropsychiatric Schizophrenia Research
ClinicalTrials.gov Identifier: NCT00541398     History of Changes
Other Study ID Numbers: 0-204-03-9-9
Study First Received: October 9, 2007
Last Updated: October 30, 2009
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Antipsychotic polypharmacy
Schizophrenia
Implementation of clinical guidelines

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014