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

为了解决阿片类药物危机，并获得 SAMHSA 州阿片类药物定向响应计划的资助 继佛蒙特州中心之后，加利福尼亚州的危机补助金药物辅助治疗扩展项目将紧随其后 和辐条模型，建立加州轴辐系统（CA H&SS），用于扩大产能 阿片类药物使用障碍 (OUD) 的药物辅助治疗 (MAT)，重点是原发性丁丙诺啡 护理设置。虽然佛蒙特州的中心辐射型阿片类药物治疗模式已显示出良好的影响， 通过让患者协作参与慢性病的治疗计划，可以改善患者的治疗结果 OUD 等条件。响应 RFA-DA-18-005（扩大药物辅助治疗 SAMHSA 阿片类药物 STR 拨款 (R21/R33) 背景下的阿片类药物使用障碍，该项目将开发 并测试名为“药物辅助治疗患者决策援助”(PtDAMAT) 的患者决策支持工具 用于 CA H&SS。 PtDA-MAT 旨在 (1) 提高患者知识和参与度 并随后提高治疗依从性和结果，(2) 支持临床医生告知和 在持续的护理过程中与 OUD 患者进行沟通。该项目将进行为期1年的R21 开发并试点测试 PtDA-MAT，以促进 CA H&SS 的共同决策，随后为期 3 年 R33 的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. 通过纳入患者决策辅助工具 (PtDA-MAT) 关于 MAT 的最佳可用科学证据以及患者和临床提供者的反馈 临床优先事项、感知效用和可接受性；目标 2. 在一个环境中对 PtDA-MAT 进行试点测试 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）和现场测试。 R33 研究的目的是通过进行阶梯楔形测试来测试 PtDA-MAT 的有效性 CA H&SS 中针对成人 OUD 的整群随机试验（按农村地区与非农村地区分层）。病人 结果将通过 (1) 个人评估（基线、3 个月和 6 个月）进行跟踪：药物使用、 用药过量、医疗保健利用以及 (2) 临床和管理记录（平均超过 24 个月）： 戒毒治疗状况和保留、身心健康诊断、逮捕、监禁、受控 物质使用和死亡率。将应用多层次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观和偏好 并将纳入科学证据，以增加患者对可能的药物风险的了解， 好处、替代方案及其相关结果。 PtDA-MAT 可能会促进基于证据的 决策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.