A Study of Strategies to Improve Schizophrenia Treatment
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: Team-Based Quality Improvement Intervention (Behavioral); Opinion Leader Intervention (Behavioral); Team Based Quality Improvement (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Richard R. Owen, MD, Principal Investigator, Affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Summary
The goal of this project is to translate research findings about key aspects of
antipsychotic treatment into routine care through a multi-component intervention, focusing
on improving two aspects of medication management that are directly linked to patient
outcomes: 1) monitoring for potentially serious metabolic side effects of newer
antipsychotic medication, and 2) increasing the appropriate use of clozapine for
treatment-refractory patients.
Clinical Details
Official title: A Study of Strategies to Improve Schizophrenia Treatment
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
Secondary outcome: Patient functional status ?Improvement in schizophrenia symptoms Service Use
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Veterans Health Care System of the Ozarks, Fayetteville, AR, Fayetteville, Arkansas 72703, United States
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR, No. Little Rock, Arkansas 72114-1706, United States
Dayton VA Medical Center, Dayton, OH, Dayton, Ohio 45428, United States
Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas 77030, United States
Additional Information
Starting date: June 2005
Last updated: April 6, 2015
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