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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date: Aug 2026 to Sep 2026
    • Secondary endpoints: details revised at 2 of 6 entries
    • Eligibility criteria shortened, about 4 words
  2. Notable Start date: May 2026 to Aug 2026v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07507435
Lead Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborators: VA Puget Sound Health Care System, Minneapolis Veterans Affairs Medical Center, Boise VA Medical Center, West Haven VA Medical Center
Conditions
(from sponsor)
HIV, Inhaled Corticosteroid, Proton Pump Inhibitor, Smoking Cessation, Pneumonia
Related terms Pneumonia, Smoking Cessation
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov