About this trial
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.
Eligibility criteria
Qualifiers
Actively smoking
Prescribed ICS for >90 days
Prescribed a PPI for >90 days
Disqualifiers
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
Trial design
Treatments tested in this trial
- E-consult
Treatment groups
Sponsors and collaborators
Seattle Institute for Biomedical and Clinical Research
Lead sponsor
VA Puget Sound Health Care System
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
Boise VA Medical Center
Collaborator
West Haven VA Medical Center
Collaborator