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: 10242705
• 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/10242705
• 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; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research Design; Research Methodology; Research Priority; Resources; Risk; Risk Factors; Risk Reduction; Services; Site; Testing; Time; Treatment Step; United States; Veterans; Veterans Health Administration; Viral; Work; antiretroviral therapy; atherosclerosis risk; base; blood treatment; budget impact; cardiovascular disorder prevention; cardiovascular disorder risk; care coordination; clinically significant; connected care; cost effectiveness; design; evidence base; experience; formative assessment; health care availability; health care service; health equity; high risk; hypertension control; implementation facilitation; improved; innovation; iterative design; medical specialties; medication compliance; member; nursing intervention; prevent; prevention evaluation; primary outcome; programs; recruit; remote delivery; screening; secondary outcome; support tools; telehealth; therapy design; tool; treatment arm; treatment as usual; uptake; virtual healthcare

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：退伍军人管理局是美国最大的艾滋病毒护理提供者。约 31,000 名感染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增加两倍 （ASCVD）与未感染的退伍军人相比。 HIV 治疗级联模型包括护理步骤；一次 人们获得缓解后，医疗服务提供者应重点预防 ASCVD。我们将扩大艾滋病毒治疗范围 级联并重点关注降低 HIV 感染者的 ASCVD 风险。感染艾滋病毒的退伍军人的认知度较低 ASCVD 风险和基于指南的 BP 治疗的采用率较低。 意义/影响：拟议的干预措施有可能减少该人群的 ASCVD 事件 超过四分之一并满足 VA 的战略重点：1) 提高服务的及时性； 2）焦点 更有效地利用资源并解决 HSR&D 研究重点：1) 以患者为中心的护理、护理 管理和健康促进； 2) 医疗保健服务； 3）老化； 4）虚拟护理。 创新：该研究具有创新性：级联模型。通过利用艾滋病毒治疗级联模型，我们将 创建一条降低 ASCVD 风险的途径，并将其纳入广泛的质量改进计划中。 利益相关者参与的设计过程。我们将采用利益相关者参与的研究方法来确保 干预满足患者和医疗保健提供者的需求。护士主导的多组成部分干预。 虽然我们干预措施的每个组成部分都有证据基础，但尚未一起进行测试 在艾滋病毒背景下。远程医疗。我们将使用 VA Video Connect (VVC) 来监测 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 关于降低艾滋病毒和心血管疾病风险的看法，为干预措施的调整提供信息。 目标 1b：根据关键利益相关者的意见，调整干预措施以适应 VA HIV 诊所的情况。 目标 2：评估护士干预措施改善退伍军人收缩压的 12 个月疗效 患有艾滋病毒。假设：我们假设我们的干预将导致具有临床意义的 6mmHg 与仅接受[强化教育+常规护理]的患者相比，12 个月内收缩压降低。目标 3： 对预防护士干预进行评估。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来评估降低 ASCVD 风险的干预措施。这 研究将在 3 个诊所针对 HIV + 退伍军人 (n = 300) 进行抑制性 ART 并确诊 SBP >140 mmHg，按临床地点分层，并按 1:1 随机分配至干预组与教育对照组。干预 将涉及 4 个基于证据的组成部分，这些组成部分基于我们之前的研究并针对感染艾滋病毒的退伍军人进行了调整：(1) 护士主导的护理协调，(2) 护士管理的药物治疗和依从性支持 (3) 家庭血压监测， (4) 管理 VA 视频连接 (VVC)。教育控制将得到加强教育和 平时的护理。主要结局：干预组与对照组 12 个月收缩压的差异。中学 结果：非 HDL 胆固醇 12 个月的差异。我们将使用混合方法设计来评估保真度， 递送/接收的剂量、范围、招募和干预背景。 实施/后续步骤：我们设计干预措施时考虑了下游实施。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 选择教育/经验水平与健康教练相匹配的护士的指南 在 VA 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 护理和艾滋病毒/艾滋病护理办公室有关实施计划。我们将传播临床计划， 包括脚本和所有干预流程的描述，以促进 VA 内的实施。