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Набор скоро начнётся NCT07714239

Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure

Без фазы С лечением Heart Failure Heart Failure, Systolic

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: Pharmacist/Cardiologist Virtual Team Digital Consultation.
Кому может быть актуально
Состояния в реестре: Heart Failure, Heart Failure, Systolic. 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

Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF) (QUE 25-018)

Обзор

Many Veterans who are hospitalized with heart failure do not receive all the recommended heart medications at the right doses before they leave the hospital or in the weeks following discharge. This study tests whether a team of clinical pharmacists and cardiologists, working virtually, can improve heart failure medication prescribing for Veterans at VA medical centers. The pharmacist and cardiologist team reviews patient records and provides recommendations to the treating doctors and primary care providers caring for Veterans with heart failure. The goal is to increase use of guideline-recommended medications, which have been shown to improve survival, reduce hospitalizations, and improve quality of life.

Подробное описание

Heart failure with reduced ejection fraction (HFrEF) affects a large proportion of Veterans and isa leading cause of hospitalization and death. Clinical guidelines recommend four classes of medications (commonly called "quadruple therapy") that improve survival and reduce hospitalizations, yet 42% of Veterans hospitalized with heart failure do not receive all recommended medications at discharge.

This study implements a virtual pharmacist and cardiologist team (hub) that provides digital consultation to hospitalists and primary care providers (spoke) at VA medical centers regarding use of guideline-directed medical therapy (GDMT) during hospitalization and the post-discharge period. The pharmacist/cardiologist team identifies eligible Veterans using a VA hospital-specific dashboard, reviews electronic health records, and places digital consultation notes with individualized medication recommendations, safety surveillance information, and out-of-pocket medication cost data.

The intervention also incorporates identification of Veterans hospitalized in VA-paid community care settings. Veterans hospitalized with heart failure in community hospitals within the preceding 3 months are identified via VA-paid community care claims data, and actionable recommendations are provided through the VA electronic health record or by facsimile to community providers.

Six VA medical centers served by Clinical Resource Hubs in VISNs 4, 16, 17, 19, and 23 are participating. Sites are randomized to one of three implementation waves in a cluster-randomized stepped-wedge design, with implementation occurring every 6 months at two sites per wave. This design allows estimation of intervention effects using both within- and between-site comparisons while controlling for secular trends. A difference-in-differences analytic approach with covariate-constrained randomization is used to estimate causal effects.

The primary effectiveness outcome is change in GDMT optimization score from admission to 14 days after discharge. Secondary effectiveness/safety outcomes include mortality, heart failure readmission, and medication-related adverse events at 90 days. Implementation outcomes are assessed using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and include fidelity to identification of at-risk Veterans, provision of recommendations,, outpatient follow-up rates, and barriers and facilitators to implementation Additional outcomes derived from the RE-AIM framework will also be captured.

Вмешательства

  • Поведенческое Pharmacist/Cardiologist Virtual Team Digital Consultation
    A centralized pharmacist and cardiologist virtual team (hub) provides protocol-based digital consultation notes to inpatient and outpatient providers(spoke) regarding initiation and intensification of guideline-directed medical therapy (GDMT) for heart failure during hospitalization and the post-discharge transitional care period. Eligible Veterans are identified via VA dashboards and community care claims data. Recommendations cover quadruple therapy (beta blockers, ACEI/ARB/ARNI, MRA, SGLT2i)

Первичные конечные точки

  • Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score [Срок оценки: From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)]
Вторичные конечные точки (6)
  • Change in NIH Heart Failure Collaboratory Score [Срок оценки: From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)]
  • All-cause mortality [Срок оценки: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)]
  • Heart Failure Readmission [Срок оценки: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)]
  • Medication-related adverse outcomes - acute kidney injury [Срок оценки: 90 days after hospital discharge or Veteran eligibility identification]
  • Medication-related adverse outcomes - bradycardia [Срок оценки: 90 after hospital discharge or Veteran eligibility identification]
  • Medication-related adverse outcomes - hyperkalemia [Срок оценки: 90 days after hospital discharge or Veteran eligibility identification]

Критерии участия

Критерии включения

  • Admission to a VA medical center or VA-paid community hospital within the preceding 3 months with a primary diagnosis of heart failure
  • The primary study cohort will consist of those admitted to a VA medical center, while the secondary study cohort will consist of patients admitted to VA-paid community hospitals
  • Left ventricular ejection fraction ≤ 40%
  • Not on optimal guideline-directed heart failure medication classes or doses, as assessed in the electronic health record
  • Receiving care within one of the 6 participating VA medical centers

Критерии исключения

  • Hemodynamic instability
  • Receiving comfort care measures alone or enrolled in hospice

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora

Идентификаторы

NCT: NCT07714239 · QUX 26-006 · QUE 25-018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗