Examining the effectiveness of a shared decision making intervention for antipsychotic medications to improve engagement in treatment for people experiencing early psychosis

项目摘要 共享决策(SDM)是一个在患者和临床医生之间进行公开讨论的过程 改善治疗参与度和护理质量的目标。累积的研究以及最近的 美国精神病学协会版治疗精神分裂症患者的实践指南 精神分裂症患者在决定是否服用抗精神病药物(APM)时认识到SDM的必要性 确定精神科护理中缺乏SDM是导致APM使用不一致的一个因素。高比率的 首发患者中过早停止治疗和不一致使用APM 精神病(FEP)是复发和临床恶化的高危人群，他们将SDM作为公共卫生优先事项。 NIMH认为SDM是协调专科护理(CSC)治疗模式的框架 FEP以改善护理和参与度。然而，到目前为止，关于使用 SDM及其在精神科就诊中的实际使用。此外，APM决策的循证SDM干预 在精神病学中，特别是在早期精神病中，缺乏对SDM的护理，SDM的机制尚不明确。 为了填补这些空白，我们的项目提供了第一个基于证据的SDM干预，用于做出以下决策 在FEP CSC治疗模型中的APM。我们将进一步发展我们现有的SDM精神病干预措施， 抗精神病药物辅助用药(APM-DA)是根据最高标准开发的 国际患者决策辅助标准(IPDAS)和质量标准。我们假设使用 针对FEP的APM管理的精神科就诊中的APM-DA干预将改善SDM目标 (信任临床医生，积极参与APM决策，APM和FEP知识)，这将产生 改善SDM近端(SDM水平、计划参与度、持续使用APM)和远端结果 (积极的康复态度，随着时间的推移症状不那么严重，急诊室就诊和住院次数减少)。这位飞行员 有效性试验有两个目的。在目标1中，我们将制定一项交付协议和培训材料，以供使用 大型CSC项目OnTrackNY中的APM-DA精神科就诊。第一步涉及到质化的形成性 研究以制定方案和培训材料(25次访谈)，步骤2涉及公开试点试验 与20名患者一起进行最终完善的方案和培训材料。在目标2中，我们将进行 在6个CSC诊所聚集120名患者(每组60人)进行随机对照试验，以测试潜在的机制/靶点 与常规治疗相比，APM-DA干预的影响。成功完成后将导致 循证SDM干预，解决NIMH提高APM质量的战略目标 精神病患者的管理。完成后，将进行更大规模的APM-DA临床试验 通过随后的R01。

Project Summary Shared decision making (SDM) is a process that involves open discussion between patient and clinician with the goal of improving treatment engagement and quality of care. Cumulative research as well as the recent edition of the American Psychiatric Association Practice Guideline for the Treatment of Patients with Schizophrenia recognize the need for SDM when making decisions about antipsychotic medication (APM) and identify the lack of SDM in psychiatric care as a factor contributing to inconsistent APM use. The high rates of premature treatment discontinuation and inconsistent use of APM among individuals with first episode psychosis (FEP), who are at high risk for relapse and clinical deterioration, make SDM a public health priority. SDM is considered by the NIMH to be a framework within a coordinated specialty care (CSC) treatment model for FEP to improve care and engagement. Yet, to date, there is a gap between recommendations for using SDM and its actual use in psychiatric visits. In addition, evidence-based SDM interventions for APM decisions in psychiatry, especially in early psychosis care, are lacking, and the mechanism of SDM is yet to be defined. To fill these gaps, our project provides the first evidence-based SDM intervention for making decisions about APM within a FEP CSC treatment model. We will further develop our existing SDM intervention for psychosis, the Antipsychotic Medication Decision Aid (APM-DA), which was developed according to the highest International Patient Decision Aid Standards (IPDAS) and quality criteria. We hypothesize that the use of the APM-DA intervention in psychiatric visits focused on APM management for FEP will improve SDM targets (trust in the clinician, active participation in APM decisions, knowledge of APM and FEP), which will produce improved SDM proximal (level of SDM, program engagement, consistent use of APM) and distal outcomes (positive recovery attitudes, less severe symptoms over time, fewer ED visits and hospitalizations). This pilot effectiveness trial has two aims. In Aim 1, we will develop a delivery protocol and training materials for using the APM-DA in psychiatric visits in a large CSC program, OnTrackNY. Step 1 involves a qualitative formative study to develop the protocol and training materials (25 interviews), and Step 2 involves an open pilot trial of the protocol and training materials for final refinement with 20 patient participants. In Aim 2, we will conduct a cluster RCT at 6 CSC clinics with 120 patient participants (60 in each arm) to test potential mechanism/targets and impact of the APM-DA intervention compared with treatment as usual. Successful completion will result in an evidence-based SDM intervention that addresses an NIMH strategic goal to improve the quality of APM management for individuals with psychosis. Upon completion, a larger APM-DA clinical trial will be conducted via a subsequent R01.