A Study of Strategies to Improve Schizophrenia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 8
- 主要终点
- Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
时间窗: 6 months
次要结局
- Patient functional status ?Improvement in schizophrenia symptoms Service Use