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

护士主导的干预措施，旨在扩大退伍军人艾滋病毒治疗级联以预防心血管疾病 (V-EXTRA-CVD)

• 批准号: 10064162
• 负责人: Hayden B Bosworth
• 金额: --
• 依托单位: DURHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10064162
• 关键词: AIDS/HIV problem; Achievement; Address; Adherence; Aging; Atherosclerosis; Blood Pressure; Caring; Chronic Disease; Clinic; Clinical; Complex; Computerized Medical Record; Diagnosis; Disease remission; Dose; Education; Electronic Health Record; Ensure; Evaluation; Event; Evidence based intervention; Foundations; Funding; Goals; Guidelines; HIV; Health; Health Personnel; Health Promotion; Health Services Accessibility; Healthcare; Home Blood Pressure Monitoring; Hyperlipidemia; Intervention; Interview; Methodology; Methods; Modeling; Monitor; Nurses; Pathway interactions; Patient-Centered Care; Patients; Perception; Pharmaceutical Preparations; Population; Practice Management; Prevention education; Prevention therapy; Primary Health Care; Process; Protocols documentation; Provider; Randomized; Randomized Clinical Trials; Research Design; Research Methodology; Research Priority; Resources; Risk; Risk Factors; Risk Reduction; Services; Site; Testing; Time; Treatment Step; United States; Veterans; Viral; Work; antiretroviral therapy; atherosclerosis risk; base; blood treatment; budget impact; cardiovascular disorder prevention; cardiovascular disorder risk; care coordination; clinically significant; cost effectiveness; design; effective intervention; evidence base; experience; formative assessment; health administration; health care availability; health care service; health equity; high risk; hypertension control; improved; innovation; iterative design; medical specialties; medication compliance; member; nursing intervention; prevent; prevention evaluation; primary outcome; programs; recruit; screening; secondary outcome; support tools; telehealth; therapy design; tool; treatment arm; treatment as usual; uptake; virtual

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.

背景：退伍军人事务部是美国最大的艾滋病毒护理提供者。约31,000名携带艾滋病毒的退伍军人 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进行比较。艾滋病毒治疗级联模式包括护理步骤；一旦 人们获得缓解，提供者应该把重点放在预防ASCVD上。我们将延长艾滋病毒的治疗时间 将重点放在降低艾滋病毒携带者的ASCVD风险上。携带艾滋病毒的退伍军人知晓率较低 ASCVD的风险和采用指南为基础的治疗BP的风险很低。 意义/影响：拟议的干预措施有可能减少这一人群中的ASCVD事件 超过四分之一并满足退伍军人管理局的战略优先事项：1)提高服务的及时性；2)专注 更高效的资源以及解决HSR和D研究的优先事项：1)以患者为中心的护理、护理 管理和健康促进；2)医疗保健；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式，我们将 为降低ASCVD风险创造一条途径，将其纳入广泛的质量改进计划。 利益相关者参与的设计流程。我们将采用利益相关者参与的研究方法，以确保 干预措施满足了患者和医疗保健提供者的需求。多组分护士主导干预。 虽然我们干预措施的每个组成部分都有证据基础，但它们并没有一起进行测试 在艾滋病毒的背景下。远程医疗。我们将使用VA Video Connect(VVC)来监控CVD风险因素。 具体目标：目标1a：对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看法，以告知干预适应。 目标1b：使干预措施适应退伍军人事务部艾滋病毒临床环境，并提供关键利益相关者的意见。 目的2：评估护士干预改善退伍军人收缩压的12个月效果 艾滋病毒携带者。假设：我们假设我们的干预将导致具有临床意义的6毫米汞柱 与那些只接受[强化教育+常规护理]的人相比，在12个月内降低了SBP。目标3： 对预防性护理干预进行评价。探索性目标：如果有效，[我们将进行 预算影响分析]，并模拟护士干预的10年成本效果。 方法：我们将与CARE团队和退伍军人进行定性访谈，以适应干预 一个迭代的设计过程。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。这个 将在3家诊所对HIV阳性退伍军人(n=300)进行关于确诊为SBP的抑制性ART的研究 &gt；140毫米汞柱，按临床地点分层，并随机1：1进行干预和教育控制。干预措施 将涉及4个基于我们先前研究的循证因素，适用于携带艾滋病毒的退伍军人：(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)家庭血压监测， 和(4)管理VA视频连接(VVC)。教育控制将接受强化教育和 照常照看。主要结果：干预组与对照组12个月收缩压的差异。次要的 结果：非高密度脂蛋白胆固醇的12个月差异。我们将使用混合方法设计来评估保真度， 提供/接收的剂量、覆盖范围、招募和干预的背景。 实施/下一步：我们针对下游实施设计了干预措施。这 包括：完全远程交付干预措施，以便利获取和广泛实施；以及 选择学历/经验水平与健康教练相匹配的护士的指导方针 在退伍军人事务部内提供干预措施。我们将与互联办公室的运营合作伙伴合作 关爱和艾滋病毒/艾滋病关爱办公室关于执行计划的建议。我们将传播一个临床项目， 包括脚本和所有干预过程的描述，以促进在退伍军人管理局内的实施。