Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 试验地点
- 3
- 主要终点
- Proportion of recommended medication changes enacted within 3 months
研究概览
简要总结
People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality. Several modifiable factors increase this risk, including active smoking, inadequate receipt of respiratory vaccinations, and inappropriate or prolonged use of inhaled corticosteroids (ICS) or proton-pump inhibitors (PPIs).
OPTIMIZE Lung-HIV is a multicenter, patient-level randomized controlled hybrid Type 1 effectiveness-implementation trial evaluating whether a proactive, pharmacist-led E-consult intervention can improve evidence-based pulmonary pharmacotherapy for PWH. Pharmacists will review electronic health records, generate tailored recommendations, and pre-enter orders related to smoking cessation pharmacotherapy, vaccinations, and deprescribing of ICS or PPIs. Providers may enact or modify recommendations as clinically appropriate.
The trial will assess the proportion of recommendations enacted within 3 months (primary outcome) and at 12 months (maintenance) and will use mixed methods guided by CFIR and RE-AIM to evaluate adoption, feasibility, acceptability, and implementation barriers and facilitators.
详细描述
Despite reductions in opportunistic infections, PWH remain at significantly higher risk for community-acquired pneumonia than people without HIV, with increased susceptibility to pneumococcal disease, influenza hospitalization, and COVID-19-related complications. Pneumonia in PWH leads to substantial short- and long-term consequences, including respiratory failure, cardiovascular events, cognitive decline, and worsening of chronic lung disease. Several pneumonia risk factors are common yet modifiable, including cigarette smoking, inappropriate ICS and PPI use, and missed respiratory vaccinations.
Proactive E-consults have proven effective in improving COPD care for PWH in prior work by our group (ACHIEVE). OPTIMIZE adapts this approach by shifting E-consult delivery from pulmonologists to clinical pharmacists, who are already integrated into primary and specialty care workflows within the Veterans Health Administration. Pharmacists will use a structured review process to identify opportunities for smoking cessation pharmacotherapy, deprescribing of ICS or PPIs, and respiratory vaccination updates. Recommendations will be communicated through a BLUF-formatted E-consult with pre-entered orders to reduce provider burden while preserving provider autonomy.
The trial uses a randomized design in which completed pharmacist reviews are allocated 1:1 to intervention or usual care. Providers in the intervention arm receive the E-consult before the patient visit; those in the usual care arm do not. Outcome assessors will be blinded.
In addition to measuring clinical effectiveness, the study will conduct interviews and surveys with HIV providers, implementation stakeholders, and patients to understand determinants of successful implementation and potential for wider dissemination. Findings will inform scalability of pharmacist-led proactive E-consults across the VHA and other learning health systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PWH with an active prescription of ART any time in past 6 months and <200 copies/mL within past 12 months, actively receiving care at the VA, and one of the following:
- •Actively smoking
- •Prescribed ICS for >90 days
- •Prescribed a PPI for >90 days
排除标准
- •Enrolled in palliative care or hospice
- •If a non-VA provider is the main primary care or HIV provider
- •Are currently participating in a separate ongoing interventional clinical trial
研究组 & 干预措施
No Intervention: Usual care
HIV+ Patients in this arm will receive usual care from their provider
Proactive E-consult
HIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments
干预措施: E-consult (Other)
结局指标
主要结局
Proportion of recommended medication changes enacted within 3 months
时间窗: Within 3 months
Numerator = Number of recommended medication changes ordered (by provider) and filled (by patient). Denominator = Number of medication changes recommended by pharmacist E-consult. Outcomes extracted by data query from VA Electronic Health Record (EHR) pharmacy data.
次要结局
- Proportion of vaccine recommendations enacted.(Within 3 months)
- Proportion of medication recommendations enacted or later rescinded.(12 months)
- Proportion of vaccine recommendations enacted.(12 months)
- Changes in smoking status.(12 months)
- Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events.(12 months)
- Changes in smoking cessation pharmacotherapy, inhaled corticosteroids, proton pump inhibitors made by providers that were not part of E- consult recommendations.(12 months)