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）是一个过程，涉及患者和临床医生之间的公开讨论， 提高治疗参与度和护理质量的目标。累积的研究以及最近的 美国精神病学协会治疗精神分裂症患者的实践指南 精神分裂症患者在决定服用抗精神病药物（APM）时认识到需要SDM， 确定精神病护理中缺乏SDM是导致APM使用不一致的一个因素。率高 在首次发作的个体中提前停止治疗和不一致地使用APM 精神病（FEP）复发和临床恶化的高风险人群使SDM成为公共卫生优先事项。 SDM被NIMH认为是协调专科护理（CSC）治疗模式的框架 以改善护理和参与。然而，到目前为止，使用建议之间存在差距 SDM及其在精神科就诊中的实际使用。此外，可持续发展机制对APM决策的循证干预 在精神病学中，特别是在早期精神病护理中，缺乏，并且SDM的机制尚未被定义。 为了填补这些空白，我们的项目提供了第一个以证据为基础的SDM干预， FEP CSC治疗模型中的APM。我们将进一步发展我们现有的SDM干预精神病， 抗精神病药物决策援助（APM-DA），这是根据最高的开发 国际患者决策辅助标准（IPDAS）和质量标准。我们假设使用 在精神科就诊中进行APM-DA干预，重点关注FEP的APM管理，将改善SDM目标 （信任临床医生，积极参与APM决策，了解APM和FEP），这将产生 改善SDM近端（SDM水平、项目参与、APM的一致使用）和远端结局 （积极的恢复态度，随着时间的推移症状不太严重，艾德就诊和住院次数减少）。这一试点 有效性试验有两个目的。在目标1中，我们将制定一个交付协议和培训材料， APM-DA在大型CSC项目OnTrackNY的精神科就诊中。第一步是一个定性的形成 第二步是进行一项公开的试点试验， 方案和培训材料，以供20名患者参与者最终完善。在目标2中，我们将进行 在6家CSC诊所进行随机对照试验，120名患者参与（每组60名），以测试潜在机制/靶点 与常规治疗相比，APM-DA干预的影响。成功完成将导致 基于证据的SDM干预，解决NIMH的战略目标，以提高APM的质量 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 通过后续的R 01。

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.