Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Implementation of guideline
Sponsored by

About this trial
This is an interventional health services research trial for Schizophrenia focused on measuring Antipsychotic polypharmacy, Schizophrenia, Implementation of clinical guidelines
Eligibility 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.
Sites / Locations
- CNSR
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Prevalence of antipsychotic polypharmacy
Secondary Outcome Measures
Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.
Full Information
NCT ID
NCT00541398
First Posted
October 9, 2007
Last Updated
October 30, 2009
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
National Board of Health, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00541398
Brief Title
Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Official Title
Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
National Board of Health, Denmark
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Antipsychotic polypharmacy, Schizophrenia, Implementation of clinical guidelines
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Implementation of guideline
Intervention Description
Outreach visits with interactive education for health staff
Primary Outcome Measure Information:
Title
Prevalence of antipsychotic polypharmacy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birte Glenthøj, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
CNSR
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Antipsychotic Polypharmacy: Prevalence, Background and Consequences
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