Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: E-consult.
- Who it may be relevant to
- Registry conditions: HIV, Inhaled Corticosteroid, Proton Pump Inhibitor, Smoking Cessation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)
Overview
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.
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.
Interventions
- 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
Primary outcome measures
- Proportion of recommended medication changes enacted within 3 months [Time frame: Within 3 months]
Secondary outcome measures (6)
- Proportion of vaccine recommendations enacted. [Time frame: Within 3 months]
- Proportion of medication recommendations enacted or later rescinded. [Time frame: 12 months]
- Proportion of vaccine recommendations enacted. [Time frame: 12 months]
- Changes in smoking status. [Time frame: 12 months]
- Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events. [Time frame: 12 months]
- Changes in smoking cessation pharmacotherapy, inhaled corticosteroids, proton pump inhibitors made by providers that were not part of E- consult recommendations. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Boise VA Medical Center — Boise
- Minneapolis VA Health Care System — Minneapolis
- VA Puget Sound Health Care System — Seattle
Identifiers
NCT: NCT07507435 · 1R01HL179905-01