Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder

解决阿片类药物危机，并在SAMHSA国家的资助下，有针对性地应对阿片类药物 危机赠款，加利福尼亚州的药物辅助治疗扩展项目将紧随佛蒙特州的Hub 和辐条模式，以建立加利福尼亚中心和辐条系统(CA H&SS)，用于 阿片类药物使用障碍的药物辅助治疗(MAT)，重点是丁丙诺啡在初级 护理设置。虽然佛蒙特州的中心和辐射型阿片类药物治疗模式显示出良好的效果， 通过让患者共同参与治疗计划，可以改善患者的预后 诸如OUD之类的条件。响应RFA-DA-18-005(扩大药物辅助治疗 阿片类药物使用障碍在SAMHSA阿片类药物STR赠款的背景下，该项目将制定 并测试称为药物辅助治疗患者决策辅助工具(PtDAMAT)的患者决策支持工具 用于CA H&SS。PtDA-MAT旨在(1)提高患者的知识和参与度 并随后改善治疗依从性和结果，以及(2)支持临床医生告知和 通过一连串的护理，与患者进行沟通。该项目将进行1年的R21 开发和试行PtDA-MAT以促进CA H&SS的共享决策，为期3年 在随机对照试验中评估PtDA-MAT的有效性。 R21研究的目标是：目标1.通过结合以下内容开发患者决策辅助工具(PtDA-MAT 关于MAT的最佳可用科学证据以及来自患者和临床提供者的反馈 临床优先事项、感知的效用和可接受性；目标2.在 由专家小组指导并涉及关键利益相关者(例如，患者、医生、 政策制定者)和实地测试。 R33研究的目的是通过进行阶梯形楔形来测试PtDA-MAT的有效性 在CA H&SS(按农村和非农村地区分层)中对患有OUD的成年人进行的整群随机试验。有耐心的 结果将通过(1)个人评估(基线、3个月和6个月)来跟踪：药物使用， 服药过量、医疗保健利用，以及(2)临床和行政记录(平均24个月)： 药物治疗状况和保留、身心健康诊断、逮捕、监禁、管制 物质使用和死亡率。将应用多水平模型来检验干预效果，控制 可能的时间趋势。 我们提出的以患者为中心的决策工具考虑了患者的价值和偏好 并将纳入科学证据，以增加患者对可能的用药风险的了解， 利益、替代方案及其相关结果。PtDA-MAT可能会促进基于证据的 并促进以患者为中心的护理，从而改善OUD患者的MAT结果。

To address the opioid crisis, and with funding from SAMHSA State Targeted Response to the Opioid Crisis Grants, California’s Medication Assisted Treatment Expansion Project will follow after Vermont’s Hub and Spoke model to establish a California Hub and Spoke system (CA H&SS) for capacity expansion in medication-assisted treatment (MAT) for opioid use disorder (OUD), with a focus on buprenorphine in primary care settings. While Vermont’s Hub and Spoke opioid treatment model has demonstrated favorable impacts, patient outcomes can be improved by engaging patients collaboratively in treatment planning for chronic conditions such as OUD. In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDAMAT) for use in the CA H&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial. The aims of the R21 study are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing. The aim of the R33 study is to test the effectiveness of PtDA-MAT by conducting a stepped-wedge cluster-randomized trial in CA H&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over an average of 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends. The patient-centered decision tool we have proposed takes account of patient values and preferences and will incorporate scientific evidence to increase patients’ understanding of possible medication risks, benefits, alternatives, and their associated outcomes. The PtDA-MAT is likely to facilitate evidence-based decisions and promote patient-centered care, leading to improved outcomes for MAT for patients with OUD.