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

Not yet recruiting at 2 trial locations
JR
Overseen ByJohn R Kundzins, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Seattle Institute for Biomedical and Clinical Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

KA

Kristina A. Crothers, MD

Principal Investigator

VA Puget Sound Health Care System

KM

Ken M Kunisaki, MD,MS

Principal Investigator

Boise VA Medical Center

OV

Orly Vardeny, PharmD

Principal Investigator

Minneapolis Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

1. Actively smoking
2. Prescribed ICS for \>90 days
3. Prescribed a PPI for \>90 days
See 1 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Proactive E-consultExperimental Treatment1 Intervention
Group II: No Intervention: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials
55
Recruited
13,700+

VA Puget Sound Health Care System

Collaborator

Trials
67
Recruited
225,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials
77
Recruited
355,000+

West Haven VA Medical Center

Collaborator

Trials
1
Recruited
640+

Boise VA Medical Center

Collaborator

Trials
1
Recruited
20+