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

检查抗精神病药物共同决策干预的有效性，以提高早期精神病患者的治疗参与度

• 批准号: 10510009
• 负责人: LISA B. DIXON
• 金额: $ 26.47万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10510009
• 关键词: Accreditation; Address; Adherence; Adopted; American Psychiatric Association; Antipsychotic Agents; Attitude; Behavior Therapy; Benefits and Risks; Caring; Chronic Disease; Clinic; Clinical; Clinical Trials; Communication; Communities; Coordinated Specialty Care; Data; Data Collection; Decision Aid; Decision Making; Deterioration; Development; Distal; Early Intervention; Early treatment; Effectiveness; Emergency department visit; Environment; Goals; Healthcare Systems; Hospitalization; Individual; Infrastructure; International; Intervention; Interview; Investigational Therapies; Knowledge; Learning; Medication Management; Modeling; Modernization; National Institute of Mental Health; New York; Outcome; Participant; Patients; Pennsylvania; Persons; Pharmaceutical Preparations; Pilot Projects; Practice Guidelines; Process; Protocols documentation; Provider; Psychiatric therapeutic procedure; Psychiatrist; Psychiatry; Psychoses; Quality of Care; Randomized; Recommendation; Recovery; Research; Research Design; Sample Size; Schizophrenia; Site; Standardization; Symptoms; Testing; Therapeutic; Time; Training; Trust; Uncertainty; United States National Institutes of Health; Visit; Work; arm; comparison intervention; early experience; early psychosis; effectiveness study; effectiveness testing; effectiveness trial; evidence base; expectation; first episode psychosis; health communication; high risk; improved; intervention program; patient-clinician communication; personalized medicine; pilot test; pilot trial; premature; programs; psychiatric symptom; public health priorities; relapse risk; shared decision making; side effect; treatment as usual; treatment guidelines; treatment program; usability

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.

项目概要 共享决策 (SDM) 是一个涉及患者和临床医生之间公开讨论的过程 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研究 美国精神病学协会治疗患有以下疾病的患者的实践指南 精神分裂症患者在做出抗精神病药物 (APM) 决策时认识到 SDM 的必要性，并且 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。的高比率 首次发作患者过早停止治疗和不一致使用 APM 精神病（FEP）患者复发和临床恶化的风险很高，因此 SDM 成为公共卫生优先事项。 NIMH 认为 SDM 是协调专业护理 (CSC) 治疗模式中的一个框架 FEP 改善护理和参与度。然而，迄今为止，使用建议之间存在差距 SDM 及其在精神病就诊中的实际应用。此外，针对 APM 决策的基于证据的 SDM 干预措施 精神病学尤其是早期精神病护理方面的研究还很缺乏，SDM的机制尚未明确。 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 干预措施，用于做出以下决策： FEP CSC 治疗模型中的 APM。我们将进一步发展现有的精神病 SDM 干预措施， 抗精神病药物决策辅助（APM-DA），是根据最高标准制定的 国际患者决策辅助标准 (IPDAS) 和质量标准。我们假设使用 APM-DA 对精神病就诊的干预重点是 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、计划参与、APM 的一致使用）和远端结果 （积极的康复态度，随着时间的推移，严重症状减轻，急诊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，我们将制定交付协议和培训材料以供使用 APM-DA 参与大型 CSC 项目 OnTrackNY 的精神病就诊。第 1 步涉及定性形成 研究制定方案和培训材料（25 次访谈），第 2 步涉及公开试点试验 方案和培训材料供 20 名患者参与者最终完善。在目标 2 中，我们将进行 在 6 个 CSC 诊所开展集群随机对照试验，共有 120 名患者参与者（每组 60 名），以测试潜在的机制/目标 以及 APM-DA 干预与常规治疗相比的影响。成功完成将导致 基于证据的 SDM 干预措施，旨在实现 NIMH 提高 APM 质量的战略目标 对精神病患者的管理。完成后，将进行更大规模的APM-DA临床试验 通过后续的 R01。