Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia

描述（申请人提供）：抗精神病药物依从性差可导致精神分裂症患者复发、再住院和预后不良。我们已经证明，在一项名为认知适应训练（CAT）的计划及其对应的PharmCAT（仅关注药物依从性）中使用环境支持（标志、警报、物品组织）可以提高依从性和结果。PharmCAT包括每周家访，以建立和维持绕过认知和情境问题的环境支持，并提示按处方服用药物。我们的目标是开发最具成本效益的方法来提高依从性。新技术，如Med-eMonitor（TM），一种专门的药丸容器（能够提示服用药物，当患者服用错误的药物或在错误的时间服用药物时警告患者，记录副作用投诉，并通过自动下载到安全网站及时提醒治疗人员未能按处方服用药物），是PharmCAT治疗中所做的电子模拟。使用更多依赖技术而较少依赖治疗人员上门访问的MM可能有助于为更广泛的患者提供环境支持。我们将150例服用非典型抗精神病药物的患者随机分配至3个治疗组之一，为期9个月：1）PharmCAT，2）Med-eMonitor（MM）或3）标准治疗（SO）。主要结局变量将包括抗精神病药物的依从性、合并用药的依从性和社区结局。混合模型的重复测量协方差分析将用于检查治疗期间结局变量的组间差异，治疗前评分用作协变量。我们假设，与标准治疗相比，几乎立即发现依从性问题的MM和提供高度个人接触的PharmCAT都将改善依从性和结局。在初步的方式，我们将比较患者的满意度和提供PharmCAT和MM治疗的直接成本。这项研究将导致干预措施的完善，以提高这一人群的依从性。如果没有适当的依从性，就无法实现有效药物治疗的最大益处。公共卫生影响包括有效的疾病管理，最大限度地提高长期结果，并控制精神分裂症的医疗保健费用。

DESCRIPTION (provided by applicant): Poor adherence to antipsychotic medication can lead to relapse, rehospitalization and poor outcomes for schizophrenia patients. We have demonstrated that the use of environmental supports (signs, alarms, organization of belongings) in a program known as Cognitive Adaptation Training (CAT) and its counterpart PharmCAT which focuses only on medication adherence improve adherence and outcomes. PharmCAT involves weekly home visits to establish and maintain environmental supports that bypass cognitive and situational problems and cue the taking of medication as prescribed. Our goal is to develop the most cost effective ways of improving adherence. New technologies such as the Med-eMonitor(tm) a specialized pill container (capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through automatic download to a secure website promptly alerting treatment staff of failures to take medication as prescribed) is an electronic analog to what is done in PharmCAT treatment. Using the MM which relies more on technology and less on in-home visits by treatment staff may help to make environmental supports available to a wider range of patients. We will randomly assign 150 patients taking atypical antipsychotics to one of 3 treatment groups for a period of 9 months: 1) PharmCAT, 2) Med-eMonitor (MM) or 3) standard treatment (SO). Primary outcome variables will include compliance to antipsychotic medication, compliance to concomitant medication, and community outcomes. Repeated Measures Analyses of Covariance for mixed models, will be utilized to examine group differences on the outcome variables during treatment with pretreatment scores used as covariates. We hypothesize that both MM which identifies adherence problems almost immediately and PharmCAT which provides a high degree of personal contact will improve adherence and outcomes in comparison to standard treatment. In a preliminary manner, we will compare patient satisfaction and the direct costs of delivering PharmCAT and MM treatment. This study will lead to the refinement of interventions targeting improved adherence in this population. Maximum benefits of effective medication cannot be achieved without appropriate adherence. The public health implications include effective disease management, maximizing long-term outcomes, and containing health care costs for schizophrenia.