Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults
NCT07507435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2026-04-02
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
VA Puget Sound Health Care System
collaborator FED -
Minneapolis Veterans Affairs Medical Center
collaborator FED -
Boise VA Medical Center
collaborator FED -
West Haven VA Medical Center
collaborator UNKNOWN -
Seattle Institute for Biomedical and Clinical Research
lead OTHER
Principal Investigators
-
Kristina A. Crothers, MD · VA Puget Sound Health Care System
-
Ken M Kunisaki, MD,MS · Boise VA Medical Center
-
Orly Vardeny, PharmD · Minneapolis Veterans Affairs Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2029-03-31
- Completion
- 2029-09-30
Countries
- United States
Study Locations
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