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; 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：VA是美国最大的艾滋病毒护理提供者。约有31,000名艾滋病毒的退伍军人 使用更多的医疗保健，并具有高达2倍的动脉粥样硬化心血管疾病的风险 （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，提供者应专注于预防ASCVD。我们将扩展艾滋病毒治疗 级联和专注于降低艾滋病毒患者的ASCVD风险。艾滋病毒的退伍军人感知得很低 ASCVD的风险和对BP的基于指南的治疗的风险很低。 意义/影响：拟议的干预措施有可能减少该人群中的ASCVD事件 超过四分之一，并符合VA战略重点：1）提高服务的及时性； 2）重点 资源效率更高，并解决HSR＆D研究的重点：1）以患者为中心的护理，护理 管理和健康促进； 2）医疗保健访问； 3）衰老； 4）虚拟护理。 创新：研究是创新的：级联模型。通过利用HIV治疗级联模型，我们将 创建一个降低ASCVD风险的途径，以添加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。多组成护士主导的干预。 尽管我们干预的每个组成部分都有证据基础，但尚未一起测试 在艾滋病毒的情况下。远程医疗。我们将使用VA视频连接（VVC）监视CVD风险因素。 具体目的：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CVD风险降低的看法，以告知干预适应。 AIM 1B：通过关键利益相关者的投入将干预措施调整到VA HIV诊所的环境中。 目标2：评估护士干预的12个月疗效以改善退伍军人的收缩压 与艾滋病毒。假设：我们假设我们的干预将导致临床上显着的6mmHg 与接受[增强的教育 +常规护理]相比，SBP在12个月内减少了12个月。目标3： 对预防护士干预进行评估。探索目的：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。 方法论：我们将与护理团队和退伍军人进行定性访谈，以适应干预措施 迭代设计过程。然后，我们将进行RCT评估干预措施以降低ASCVD风险。这 研究将在抑制ART的3个诊所（n = 300）中在3个诊所进行，并确认为SBP > 140 mmHg，由诊所地点分层，然后随机分配1：1，以进行干预与教育控制。干预 将根据我们先前的研究涉及4个基于证据的组件，并适用于艾滋病毒的退伍军人：（1） 由护士领导的护理协调，（2）护士管理的药物和依从性支持（3）家庭BP监控， （4）管理VA视频连接（VVC）。教育控制将得到增强的教育，并且 通常的护理。主要结果：干预组与控制中12个月收缩BP的差异。次要 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， 干预的剂量已交付/接收，覆盖，招聘和背景。 实施/下一步：我们设计了干预措施，并考虑到下游实现。这 包括：完全远程交付干预措施，以促进访问和广泛的实施，以及 选择具有与健康教练相匹配的教育 /经验水平的护士的指南 在VA内提供干预措施。我们将与Connected办公室的运营合作伙伴合作 有关实施计划的艾滋病毒/艾滋病护理的护理和办公室。我们将传播一个临床计划， 包括脚本和所有干预过程的描述，以促进VA内的实施。