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Набор скоро начнётся NCT07507435

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

Без фазы С лечением HIV Inhaled Corticosteroid Proton Pump Inhibitor Smoking Cessation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: E-consult.
Кому может быть актуально
Состояния в реестре: HIV, Inhaled Corticosteroid, Proton Pump Inhibitor, Smoking Cessation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

  • Proportion of recommended medication changes enacted within 3 months [Срок оценки: Within 3 months]
Вторичные конечные точки (6)
  • Proportion of vaccine recommendations enacted. [Срок оценки: Within 3 months]
  • Proportion of medication recommendations enacted or later rescinded. [Срок оценки: 12 months]
  • Proportion of vaccine recommendations enacted. [Срок оценки: 12 months]
  • Changes in smoking status. [Срок оценки: 12 months]
  • Events such as pneumonia, COPD exacerbation, gastrointestinal bleeding, hospitalization, and other adverse events. [Срок оценки: 12 months]
  • Changes in smoking cessation pharmacotherapy, inhaled corticosteroids, proton pump inhibitors made by providers that were not part of E- consult recommendations. [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 3 центра
  • Boise VA Medical Center — Boise
  • Minneapolis VA Health Care System — Minneapolis
  • VA Puget Sound Health Care System — Seattle

Идентификаторы

NCT: NCT07507435 · 1R01HL179905-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗