NCT07507435

Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults

Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Seattle Institute for Biomedical and Clinical Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV
• Inhaled Corticosteroid
• Proton Pump Inhibitor
• Smoking Cessation
• Pneumonia

Interventions

Type	Name	Description
OTHER	E-consult	Pharmacist-driven e-consults to providers of people with HIV (PWH) to improve guideline-concordant care and decrease population risk of pneumonia in PWH

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-03-01
• Completion: 2029-09-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

3 sites across 1 country: United States