- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156637
A Study of Strategies to Improve Schizophrenia Treatment
Study Overview
Status
Conditions
Detailed Description
Background:
Antipsychotic medication is by far the most widely utilized treatment for schizophrenia in VA settings, and the VA has established guidelines for the appropriate use of these medications. The recent introduction of a new generation of antipsychotic medications has also offered great hope to persons with schizophrenia, but also may adversely affect health due to metabolic side effects. Improving all aspects of antipsychotic medication management is necessary to improve outcomes for persons with schizophrenia.
Objectives:
The goal of this project is to translate research findings about key aspects of antipsychotic treatment into routine care through a multi-component intervention. Mental Health QUERI's (MHQ) previous project for improving antipsychotic treatment demonstrated that a multi-component intervention improved use of guideline-recommended antipsychotic doses. This project will build on results and lessons learned from MHQ's previous translation project. The scope of translation will be expanded from an ongoing focus on reducing high antipsychotic doses to include two additional aspects of medication management that are directly linked to patient outcomes: 1) increasing monitoring for potentially serious side effects of newer antipsychotic medication, and 2) increasing the appropriate use of clozapine for treatment-refractory patients.
Methods:
The project is employing a multi-component intervention for improving antipsychotic prescribing while comparing the use of two different interpersonal marketing/influence strategies for translation. The primary objective is to compare the effectiveness of a team-based QI approach and a strategy using a clinical opinion leader augmented by an implementation coordinator to improve antipsychotic medication management. In addition, MHQ will determine the impact of a support and consultation program to promote clozapine prescribing. A total of ten VA Medical Centers from 4 different VA health care networks (VISNs) have been selected to participate on the basis of number of patients with schizophrenia, baseline performance on quality indicators, and organizational characteristics. Six of these sites will focus on side effect monitoring and antipsychotic dosing (two team-based QI, two clinical opinion leader, and two control), while two will receive the clozapine consultation program, with two matched control sites. Selected clinicians and staff (opinion leaders) will be identified and trained, and will implement the multi-component intervention consisting of educational materials and programs, information system tools, and performance monitoring and feedback. The intervention will take place for 6 months, and will be assessed with regard to improvement in side effect monitoring, high dose antipsychotic prescribing, and clozapine use. In addition, MHQ will assess impact of the intervention on patient outcomes at five of the sites.
Status:
In partnership with clinical stakeholders, the project team is implementing, adapting and evaluating an assortment of clinical tools and training materials designed to improve antipsychotic medication management. All, sites, except 1, have completed the intervention. All subject recruitment had been completed. The project team is also working with participating VAMC IT staff and Clinical Coordinators to fully automate the project's VISTA data extraction reoutines and performance monitoring reporting system for local implmentation and maintainence
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- Veterans Health Care System of the Ozarks, Fayetteville, AR
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No. Little Rock, Arkansas, United States, 72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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Ohio
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Dayton, Ohio, United States, 45428
- Dayton VA Medical Center, Dayton, OH
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Texas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
SITE: 300 or more patients with schizophrenia diagnosis Below national VA average on high antipsychotic dosing (dosing sites) or use of clozapine (clozapine sites)?Site leader buy-in
PATIENT: Clinical diagnosis of schizophrenia or schizoaffective disorder
18-65 years of age Had at least 1 inpatient stays or outpatient visits to facility in past year [Dosing Sites] Filled antipsychotic prescription at dose that exceeds guideline recommendations in past 3 months [Clozapine Sites] Scores positive on computer routine to identify potential candidates for a trial of clozapine
Exclusion Criteria:
SITE:No affiliation with an Institutional Review Board or Research and Development office for protocol review/approval PATIENT: No access to telephone Enrolled in a conflicting study
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
|
Intervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort
Intervention to increase appropriate use of clozapine through a team based quality intervention.
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Active Comparator: Arm 2
Dosing & Side Effect Monitoring
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Intervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
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Patient functional status ?Improvement in schizophrenia symptoms Service Use
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard R. Owen, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Publications and helpful links
General Publications
- Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 Jan;64(1):13-20. doi: 10.1176/appi.ps.201200142.
- Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNT 02-210
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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