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

NCT07507435 | Not Yet Recruiting DMC

• 1 other identifier: 1R01HL179905-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 3

Brief 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

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

Keywords

Pharmacist; E-consult; HIV

Outcome Measures

Primary Outcomes (1)

• Proportion of recommended medication changes enacted within 3 months

  Numerator = Number of recommended medication changes ordered (by provider) and filled (by patient). Denominator = Number of medication changes recommended by pharmacist E-consult. Outcomes extracted by data query from VA Electronic Health Record (EHR) pharmacy data.

  Within 3 months

Secondary Outcomes (6)

• Proportion of vaccine recommendations enacted.

  Within 3 months

• Proportion of medication recommendations enacted or later rescinded.

  12 months

• Proportion of vaccine recommendations enacted.

  12 months

• Changes in smoking status.

  12 months

• Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events.

  12 months

Study Arms (2)

No Intervention: Usual care

NO INTERVENTION

HIV+ Patients in this arm will receive usual care from their provider

Proactive E-consult

OTHER

HIV+ patients randomized into in this arm will have proactive E-consults with pharmacist recommendations sent to enrolled providers prior to appointments

Other: E-consult

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

Proactive E-consult

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PWH on ART for 6 months, receiving care at the VA, and one or more of the following:
• Actively smoking
• Prescribed ICS for \>90 days
• Prescribed a PPI for \>90 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• VA Puget Sound Health Care System: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• Boise VA Medical Center: collaborator
• West Haven VA Medical Center: collaborator

Study Sites (3)

Boise VA Medical Center

Boise, Idaho, 83702, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Pneumonia

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kristina A. Crothers, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

• Ken M Kunisaki, MD,MS

  Boise VA Medical Center

  PRINCIPAL INVESTIGATOR

• Orly Vardeny, PharmD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John R Kundzins, BS

CONTACT

206-277-1182; OPTIMIZEStudyTeam@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)