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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Pneumonia; HIV; Proton Pump Inhibitor; Inhaled Corticosteroid
• Intervention / Treatment: Other: E-consult

Detailed Description

Despite reductions in opportunistic infections, PWH remain at significantly higher risk for community-acquired pneumonia than people without HIV, with increased susceptibility to pneumococcal disease, influenza hospitalization, and COVID-19-related complications. Pneumonia in PWH leads to substantial short- and long-term consequences, including respiratory failure, cardiovascular events, cognitive decline, and worsening of chronic lung disease. Several pneumonia risk factors are common yet modifiable, including cigarette smoking, inappropriate ICS and PPI use, and missed respiratory vaccinations.

Proactive E-consults have proven effective in improving COPD care for PWH in prior work by our group (ACHIEVE). OPTIMIZE adapts this approach by shifting E-consult delivery from pulmonologists to clinical pharmacists, who are already integrated into primary and specialty care workflows within the Veterans Health Administration. Pharmacists will use a structured review process to identify opportunities for smoking cessation pharmacotherapy, deprescribing of ICS or PPIs, and respiratory vaccination updates. Recommendations will be communicated through a BLUF-formatted E-consult with pre-entered orders to reduce provider burden while preserving provider autonomy.

The trial uses a randomized design in which completed pharmacist reviews are allocated 1:1 to intervention or usual care. Providers in the intervention arm receive the E-consult before the patient visit; those in the usual care arm do not. Outcome assessors will be blinded.

In addition to measuring clinical effectiveness, the study will conduct interviews and surveys with HIV providers, implementation stakeholders, and patients to understand determinants of successful implementation and potential for wider dissemination. Findings will inform scalability of pharmacist-led proactive E-consults across the VHA and other learning health systems.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John R Kundzins, BS; Phone Number: 206-277-1182; Email: OPTIMIZEStudyTeam@va.gov

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83702
      • Boise VA Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PWH on ART for 6 months, receiving care at the VA, and one or more of the following:

  1. Actively smoking
  2. Prescribed ICS for >90 days

  3. Prescribed a PPI for >90 days

     Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of vaccine recommendations enacted.	Numerator = Number of recommended vaccines received by the patient Denominator = Number of vaccines recommended by pharmacist E-consult. Outcomes extracted by VA EHR data and confirmed by chart review.	Within 3 months
Proportion of medication recommendations enacted or later rescinded.	Same methods as primary outcome. Will assess later enactment of initial recommendations not completed within first 3 months of E-consult and resumption of initially deprescribed medications.	12 months
Proportion of vaccine recommendations enacted.	Same methods as within 3 months.	12 months
Changes in smoking status.	VA EHR health factors data with chart review confirmation as needed.	12 months
Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events.	VA EHR ICD codes, hospital discharge summaries, payment data (for non-VA hospitalizations) with chart review confirmation as needed.	12 months
Changes in smoking cessation pharmacotherapy, inhaled corticosteroids, proton pump inhibitors made by providers that were not part of E- consult recommendations.	VA EHR pharmacy data.	12 months

Collaborators and Investigators

• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: Minneapolis Veterans Affairs Medical Center; VA Puget Sound Health Care System; West Haven VA Medical Center; Boise VA Medical Center
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Pharmacist; E-consult
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Behavior; Health Behavior; Pneumonia; Smoking Cessation
• Other Study ID Numbers: 1R01HL179905-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No