A nurse-led intervention to extend the Veteran HIV treatment cascade for cardiovascular disease prevention (V-EXTRA-CVD)

背景：弗吉尼亚州是美国最大的艾滋病毒护理提供者。31，000名艾滋病毒感染者 使用更多的医疗保健，患动脉粥样硬化性心血管疾病的风险高达2倍 （ASCVD）与未感染的退伍军人相比。艾滋病毒治疗级联模式包括护理步骤;一旦 如果人们获得缓解，提供者应专注于预防ASCVD。我们将扩大艾滋病治疗 级联并重点降低艾滋病毒感染者中的ASCVD风险。感染艾滋病毒的退伍军人 ASCVD的风险和接受基于指南的BP治疗的风险较低。 意义/影响：拟定的干预措施有可能减少该人群中的ASCVD事件 超过四分之一，并满足VA的战略优先事项：1）提高服务的及时性; 2）重点 更有效地利用资源，并解决HSR&D研究的优先事项：1）以患者为中心的护理， 管理和健康促进; 2）医疗保健获取; 3）老龄化; 4）虚拟护理。 创新：本研究具有创新性：级联模型。通过利用艾滋病毒治疗级联模型，我们将 为ASCVD风险降低创造一条途径，将其加入到广泛的质量改进计划中。 利益相关者参与的设计过程。我们将采用企业主参与的研究方法，以确保 干预措施满足了患者和医疗保健提供者的需求。多组分护士主导的干预。 虽然我们的干预措施的每一个组成部分都有证据基础，但它们没有一起进行测试 in an HIV艾滋病context上下文.远程保健。我们将使用VA视频连接（VVC）来监测CVD风险因素。 具体目标：目标1a：与退伍军人和医疗保健提供者进行定性访谈，以确定 关于艾滋病毒和心血管疾病风险降低的认识，为干预措施的适应提供信息。 目标1b：在关键利益相关者的投入下，使干预措施适应VA HIV诊所的环境。 目的2：评价护士干预改善退伍军人收缩压的12个月疗效 感染了艾滋病毒假设：我们假设我们的干预将导致临床显著的6 mmHg 与仅接受[强化教育+常规护理]的患者相比，SBP在12个月内降低。目标3： 对预防护理干预进行评价。探索目标：如果有效，[我们将进行 预算影响分析]并模拟护士干预的10年成本效益。 方法：我们将与护理团队和退伍军人进行定性访谈，以调整干预措施， 迭代设计过程。然后，我们将进行随机对照试验，以评估降低ASCVD风险的干预措施。的 将在3家诊所对确诊SBP的HIV阳性退伍军人（n=300）进行抑制性ART研究 >140 mmHg，按诊所地点分层，并以1：1的比例随机分为干预组和教育对照组。干预 将涉及4个基于证据的组成部分，基于我们以前的研究，并适应退伍军人与艾滋病毒：（1） 护士主导的护理协调，（2）护士管理的药物和依从性支持（3）家庭BP监测， （4）VA视频连接（VVC）。教育控制将得到加强教育， 常规护理主要结局：干预组与对照组12个月收缩压的差异。二次 结果：非HDL胆固醇的12个月差异。我们将使用混合方法设计来评估保真度， 递送/接收的剂量、覆盖范围、招募和干预背景。 实施/后续步骤：我们在设计干预措施时考虑到了下游实施。这 包括：完全远程提供干预措施，以促进访问和广泛实施，以及 指导选择具有与健康教练相匹配的教育/经验水平的护士 在VA中进行干预。我们将与互联办公室的运营合作伙伴合作， 护理和艾滋病毒/艾滋病护理办公室关于执行计划。我们会推广一个临床项目， 包括脚本和所有干预过程的描述，以促进VA内的实施。

Background: The VA is the largest provider of HIV care in the United States. The ~31,000 Veterans with HIV use significantly more healthcare and have up to 2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The HIV treatment cascade model includes care steps; once people obtain remission, providers should focus on preventing ASCVD. We will extend the HIV treatment cascade and focus on reducing ASCVD risk among people with HIV. Veterans with HIV have low perceived risk for ASCVD and uptake of guideline-based treatment for BP is low. Significance/Impact: The proposed intervention has the potential to reduce ASCVD events in this population by more than a quarter and meet VA strategic priorities of: 1) improve timeliness of services; 2) focus resources more efficiently as well as address HSR&D research priorities: 1) patient centered care, care management, and health promotion; 2) healthcare access; 3) aging; 4) virtual care. Innovation: The study is innovative: Cascade Model. By leveraging the HIV treatment cascade model, we will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. We will employ stakeholder-engaged research methods to ensure the intervention meets the needs of patients and healthcare providers. Multi-component nurse-led intervention. While each of the components of our intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. We will use VA Video Connect (VVC) to monitor CVD risk factors. Specific Aims: Aim 1a: Conduct qualitative interviews with Veterans and healthcare providers to ascertain perceptions regarding HIV and CVD risk reductions to inform intervention adaptation. Aim 1b: Adapt the intervention to the VA HIV clinic context with key stakeholder input. Aim 2: Evaluate the 12-month efficacy of a nurse intervention to improve systolic blood pressure in Veterans with HIV. Hypothesis: We hypothesize that our intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving [enhanced education + usual care] only. Aim 3: Conduct an evaluation of the prevention nurse intervention. Exploratory aim: If effective, [we will conduct a budget impact analysis] and simulate 10-year cost-effectiveness of the nurse intervention. Methodology: We will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. We will then conduct a RCT to evaluate an intervention to reduce ASCVD risk. The study will be conducted in 3 clinics among HIV+ veterans (n=300) on suppressive ART with confirmed SBP >140 mmHg, stratified by clinic site and randomized 1:1 to intervention vs. education control. The intervention will involve 4 evidence-based components based on our prior studies and adapted to veterans with HIV: (1) nurse-led care coordination, (2) nurse-managed medication and adherence support (3) home BP monitoring, and (4) administered VA Video Connect (VVC). The education control will receive enhanced education and usual care. Primary outcome: difference in 12-month systolic BP in the intervention arm vs control. Secondary outcome: 12-month difference in non-HDL cholesterol. We will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention. Implementation/Next Steps: We designed the intervention with downstream implementation in view. This includes: a fully remote delivery of the intervention to facilitate access and widespread implementation, and guidance for selection of nurses with education / experience levels that match those of health coaches delivering interventions within the VA. We will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. We will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.