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

Part of paid clinical trials in Boise, Idaho.

Sponsor
Seattle Institute for Biomedical and Clinical Research
Study ID
NCT07507435
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Inhaled Corticosteroid
  • Pneumonia
  • Proton Pump Inhibitor
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E-consult — OTHER
    Pharmacist-driven e-consults to providers of people with HIV (PWH) to improve guideline-concordant care and decrease population risk of pneumonia in PWH

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: No Intervention: Usual care
    HIV+ Patients in this arm will receive usual care from their provider
  • Other: Proactive E-consult
    HIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments

Primary Outcome Measure

Proportion of recommended medication changes enacted within 3 months [ Time Frame: Within 3 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Boise VA Medical CenterBoiseIdaho83702-
Minneapolis VA Health Care SystemMinneapolisMinnesota55417-
VA Puget Sound Health Care SystemSeattleWashington98108-

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