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.
Actively smoking
Prescribed ICS for >90 days
Prescribed a PPI for >90 days
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
Parallel
E-consult
Other interventionPharmacist-driven e-consults to providers of people with HIV (PWH) to improve guideline-concordant care and decrease population risk of pneumonia in PWH
Proportion of recommended medication changes enacted 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.
Proportion of vaccine recommendations enacted.
Numerator = Number of recommended vaccines received by the patient Denominator = Number of vaccines recommended by pharmacist E-consult. Outcomes extracted by VA EHR data and confirmed by chart review.
Proportion of medication recommendations enacted or later rescinded.
Same methods as primary outcome. Will assess later enactment of initial recommendations not completed within first 3 months of E-consult and resumption of initially deprescribed medications.
Proportion of vaccine recommendations enacted.
Same methods as within 3 months.
Changes in smoking status.
VA EHR health factors data with chart review confirmation as needed.
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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
This trial is not recruiting at the moment. You can still explore other options:
