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

背景资料。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致死原因。随着高效的直接演技的到来 抗病毒药物，丙型肝炎病毒的治疗现在对绝大多数患者是治愈的。退伍军人事务部是最大的 它是世界上最大的丙型肝炎病毒治疗提供者，并加大了识别和治疗丙型肝炎病毒的力度。饮酒是不健康的 对丙型肝炎患者来说非常危险，并影响丙型肝炎治疗的依从性和结果。尽管存在风险 与此相关的是，许多丙型肝炎患者饮酒水平不健康。虽然饮酒以前是一种 治疗禁忌症，退伍军人管理局指南现在建议考虑对所有 丙型肝炎病毒，包括那些不健康饮酒的人，为重点关注以下问题的联合干预创造了一个绝佳机会 解决丙型肝炎治疗期间不健康的酒精使用问题。丙型肝炎病毒治疗-通常通过多次就诊进行- 可能会为提供循证酒精相关干预措施提供有时间限制的机会，但由于 先前的禁忌症，丙型肝炎治疗环境中的临床医生可能没有准备好提供基于证据的 与酒精有关的护理。实践便利化是一种有效的多层次实施战略，有望 促进提供与酒精有关的护理，并最终改善酒精使用和丙型肝炎结局 丙型肝炎病毒感染者和不健康的饮酒者。 目标。拟议的研究--由一个独特的实施科学和丙型肝炎病毒专家团队进行 以及与酒精相关的护理--将利用实践便利化来增加提供与酒精相关的循证证据 在丙型肝炎治疗环境中进行护理，并改善退伍军人的酒精使用和丙型肝炎治疗结果 丙型肝炎病毒和不健康的酒精使用。 方法：研究方法。该研究将以实施研究综合框架(CFIR)为指导 模特。在目标1中，我们将使用具有关键临床和患者利益相关者的半结构定性面谈 以及快速分析方法，以量身定做练习促进干预。在目标2和目标3中，我们将传播 对美国西部的4家退伍军人管理局诊所进行量身定制的干预，然后应用混合型III实施/ 评估量身定制实践促进干预对实施影响的有效性设计 (主要)和临床有效性(次要)结果。五项执行成果(可接受性、 酒精相关护理的可行性、采用率、渗透率和保真度)和三个临床结果(酒精使用、 丙型肝炎病毒治疗的完成性和持续的病毒学应答)将使用混合方法进行评估。这个 主要实施结果(渗透率)和临床结果将使用中断的 时间序列设计，其中实施干预是以阶梯式楔形方式和诊所展开的 充当自己的控件(开机自检前)。诊所接受干预的顺序将是随机的。 冲击力。这项研究与退伍军人管理局专注于心理和行为的交叉研究重点一致 健康、医疗保健可获得性、实施科学和健康差距以及退伍军人管理局致力于 为不健康的酒精使用提供以患者为中心的护理。如果有效，执行干预可以是 在退伍军人事务部丙型肝炎治疗环境中推广，这可以改善 患有丙型肝炎和不健康饮酒的退伍军人，可能会优化退伍军人管理局对丙型肝炎的大笔投资回报 通过减少停止治疗和提高治愈率来进行治疗。此外，干预将会 帮助退伍军人事务部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 即使治疗丙型肝炎的需求减少，也要饮酒。

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.