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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeattle Institute for Biomedical and Clinical Research

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

480 Participants
are divided into 2 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