Evaluating Practice Facilitation to Optimize Alcohol-Related Care and HCV Treatment Outcomes in HCV Treatment Settings

背景丙型肝炎病毒（HCV）是美国最常见的慢性病毒感染之一， 超过了所有其他传染病的死亡原因。随着高效的直接作用的 抗病毒药物，HCV的治疗现在对绝大多数患者是治愈性的。VA是最大的 该公司是世界上最大的HCV护理提供者，并加大了识别和治疗HCV的力度。不健康的酒精使用 对HCV患者非常危险，并影响HCV治疗依从性和结果。尽管存在风险 与此相关，许多HCV患者在不健康的水平上饮酒。虽然酒精使用以前是一个 治疗禁忌症，VA指南现在建议考虑治疗所有患者， 丙型肝炎病毒，包括那些不健康的酒精使用，创造了一个主要的机会，共同干预的重点是 在HCV治疗期间使用不健康的酒精。HCV治疗-通常在多次访视中进行- 可能为提供基于证据的酒精相关干预措施提供时间有限的机会，但是，由于 以前的禁忌症，临床医生在HCV治疗环境可能没有准备好提供基于证据的 酒精相关的护理实践促进是一种有效的多层次实施策略， 促进提供酒精相关的护理，并最终改善酒精使用和HCV的结果， HCV和不健康饮酒的患者。 Objective.拟议的研究-由一个独特的专家团队在实施科学和丙型肝炎病毒进行 和酒精相关的护理-将使用实践促进，以增加提供基于证据的酒精相关的 HCV治疗环境中的护理，并改善退伍军人中的酒精使用和HCV治疗结果， HCV和不健康的酒精使用 方法.这项研究将以实施研究综合框架为指导 模型在目标1中，我们将使用半结构化的定性访谈者与关键的临床和患者利益相关者 和快速分析方法，以定制实践促进干预。在目标2和3中，我们将传播 在美国西部的4个VA诊所进行量身定制的干预，然后应用混合III型实施/ 有效性设计，以评估有针对性的做法促进干预措施对实施的影响 （主要）和临床有效性（次要）结局。五项执行成果（可接受性， 酒精相关护理的可行性、采用、渗透和忠诚度）和三个临床结果（酒精使用， HCV治疗完成和持续病毒学应答）将使用混合方法进行评价。的 主要实施结局（渗透率）和临床结局，将使用中断的 时间序列设计，其中实施干预以阶梯式楔形方式推出， 作为其自身的对照（前后）。诊所接受干预的顺序将是随机的。 冲击这项研究与VA的跨领域研究优先事项保持一致，重点是精神和行为 健康，医疗保健服务，实施科学和健康差距，并与VA的承诺， 为不健康的酒精使用提供以病人为中心的护理。如果有效，执行干预措施可以 在整个VA HCV治疗环境中进行扩展，这可以改善脆弱人群的健康状况， 患有HCV和不健康酒精的退伍军人使用，并可能优化VA在HCV方面的大量投资回报 通过减少治疗中断和提高治愈率来治疗。此外，干预将 帮助VA肝脏诊所的临床医生为受以下因素影响的慢性肝病患者提供酒精相关护理： 即使对HCV治疗的需求减少，酒精的使用也会减少。

Background. Hepatitis C virus (HCV) is among the most common chronic viral infections in the U.S. and has surpassed all other infectious diseases as a cause of death. With the arrival of highly efficacious directly-acting anti-viral agents, treatment for HCV is now curative for the vast majority of patients. The VA is the largest provider of HCV care in the world and has scaled up efforts to identify and treat HCV. Unhealthy alcohol use is very risky for patients with HCV and influences HCV treatment adherence and outcomes. Despite the risks associated, many patients with HCV drink alcohol at unhealthy levels. While alcohol use was previously a contraindication to treatment, VA guidelines now recommend consideration of treatment for all patients with HCV, including those with unhealthy alcohol use, creating a prime opportunity for co-interventions focused on addressing unhealthy alcohol use during HCV treatment. HCV treatment-typically delivered over multiple visits- may provide time-limited opportunities for delivery of evidence-based alcohol-related interventions, but, due to previous contraindications, clinicians in HCV treatment settings are likely unprepared to offer evidence-based alcohol-related care. Practice facilitation is an effective multilevel implementation strategy that has promise for facilitating provision of alcohol-related care and ultimately improving alcohol use and HCV outcomes among patients with HCV and unhealthy alcohol use. Objective. The proposed study—conducted by a unique team of experts in implementation science and HCV and alcohol-related care—will use practice facilitation to increase provision of evidence-based alcohol-related care in HCV treatment settings and improve alcohol use and HCV treatment outcomes among Veterans with HCV and unhealthy alcohol use. Methods. The study will be guided by the Consolidated Framework for Implementation Research (CFIR) model. In Aim 1, we will use semi-structured qualitative interviewers with key clinical and patient stakeholders and rapid analytic methods to tailor the practice facilitation intervention. In Aims 2 and 3 we will disseminate the tailored intervention to 4 VA clinics in the western U.S. and then apply a Hybrid Type III implementation/ effectiveness design to evaluate the influence of the tailored practice facilitation intervention on implementation (primary) and clinical effectiveness (secondary) outcomes. Five implementation outcomes (acceptability, feasibility, adoption, penetration, and fidelity of alcohol-related care) and three clinical outcomes (alcohol use, HCV treatment completion, and sustained virologic response) will be evaluated using mixed methods. The primary implementation outcome (penetration) and clinical outcomes, will be evaluated using an interrupted time series design in which the implementation intervention is rolled-out in a stepped wedge fashion and clinics serve as their own controls (pre-post). Order in which the clinics receive the intervention will be randomized. Impact. The study is aligned with VA’s cross-cutting research priorities focused on mental and behavioral health, healthcare access, implementation science, and health disparities and with VA’s commitment to providing patient-centered care for unhealthy alcohol use. If effective, the implementation intervention could be scaled throughout VA HCV treatment settings, which could improve health among the vulnerable population of Veterans with HCV and unhealthy alcohol use and may optimize return on VA’s large investment in HCV treatment via reductions in treatment discontinuation and increased cure rates. Moreover, the intervention will help clinicians in VA liver clinics offer alcohol-related care to patients with chronic liver conditions influenced by alcohol use even as the demand for HCV treatment decreases.