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

为了解决阿片类药物危机，并与SAMHSA国家有针对性地应对阿片类药物的资金 危机赠款，加州的药物辅助治疗扩展项目将遵循佛蒙特州的枢纽 和辐射模式，建立加州中心辐射系统（CA H&SS），用于在 阿片类药物使用障碍（OUD）的药物辅助治疗（MAT），重点是初级治疗中的丁丙诺啡 护理机构。虽然佛蒙特州的中心和辐条阿片类药物治疗模式已经证明了有利的影响， 通过让患者参与慢性疾病的治疗计划， 条件，如。针对RFA-DA-18-005（扩大药物辅助治疗， SAMHSA阿片类药物STR赠款背景下的阿片类药物使用障碍，R21/R33），该项目将开发 并测试一种名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 与他们的OUD患者进行沿着连续护理的沟通。该项目将进行1年的R21 开发和试点测试PtDA-MAT，以促进CA H&SS的共同决策，随后3年 的R33，以评估PtDA-MAT在随机对照试验中的有效性。 R21研究的目标是：目标1。开发患者决策辅助工具（PtDA-MAT）， 关于MAT的现有最佳科学证据以及来自患者和临床提供者的反馈， 临床优先级、感知效用和可接受性;目标2。进行PtDA-MAT的试点测试， 由专家小组指导并涉及关键利益攸关方（例如，病人，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楔试验来测试PtDA-MAT的有效性 CA H&SS（按农村与非农村地区分层）成人OUD的随机分组试验。患者 将通过（1）个人评估（基线、3个月和6个月）跟踪结局：药物使用， 用药过量、医疗保健利用和（2）临床和管理记录（平均24个月）： 药物治疗状态和保留，身体和精神健康诊断，逮捕，监禁，控制 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到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， 利益、替代方案及其相关结果。PtDA-MAT可能有助于循证医学 决策和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.