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

15 de julho de 2026 atualizado por: VA Office of Research and Development

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

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

585

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Paul L Hess, MD MS
  • Número de telefone: (720) 857-6889
  • E-mail: paul.hess@va.gov

Estude backup de contato

Locais de estudo

    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contato:
        • Investigador principal:
          • Paul L Hess, MD MS

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Pharmacist/Cardiologist Virtual Team (Intervention)
VA medical centers randomized to the active intervention period receive digital consultation from a centralized pharmacist and cardiologist virtual team regarding guideline-directed medical therapy for hospitalized Veterans with heart failure and during the post-discharge period. The intervention includes identification of eligible Veterans, placement of digital consultation notes in the EHR, facilitation of outpatient follow-up, and Veteran education.
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) and are tailored to individual clinical presentations. The pharmacist arranges outpatient follow-up and delivers medication adherence education.
Outros nomes:
  • PATRIOT-HF intervention; pharmacist-assisted GDMT optimization
Sem intervenção: Usual Care (Control Period)
VA medical centers during their pre-implementation (control) period provide usual care for Veterans hospitalized with heart failure without input from the pharmacist/cardiologist virtual team. In the stepped-wedge design, all sites eventually cross over to the intervention arm.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score
Prazo: From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)
The GDMT Optimization Score reflects the proportion of eligible guideline-recommended heart failure medications prescribed relative to the total for which the Veteran is eligible. Points are assigned as follows - Numerator: ACEI/ARB=1, ARNI=2, evidence-based beta blocker=2, MRA=2, SGLT2i=2, Vericiguat=1, Ivabradine=1, Hydralazine/Nitrates=1. Denominator reflects eligibility for each class. A higher score indicates greater concordance with guidelines.
From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in NIH Heart Failure Collaboratory Score
Prazo: From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)
A composite GDMT metric assessing the breadth and completeness of guideline-recommended heart failure pharmacotherapy.
From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)
All-cause mortality
Prazo: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
Death from any cause, ascertained from the VA Death Ascertainment File.
30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
Heart Failure Readmission
Prazo: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
A claim for inpatient admission with any HF diagnosis on the claim, ascertained from the VA Corporate Data Warehouse and Consolidated Data Set.
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
Prazo: 90 days after hospital discharge or Veteran eligibility identification
Acute kidney injury identified by creatinine levels and ICD diagnostic codes in the VA Corporate Data Warehouse.
90 days after hospital discharge or Veteran eligibility identification
Medication-related adverse outcomes - bradycardia
Prazo: 90 after hospital discharge or Veteran eligibility identification
Bradycardia identified by vital sign readings and ICD diagnostic codes in the VA Corporate Data Warehouse.
90 after hospital discharge or Veteran eligibility identification
Medication-related adverse outcomes - hyperkalemia
Prazo: 90 days after hospital discharge or Veteran eligibility identification
Hyperkalemia identified by potassium laboratory values and ICD diagnostic codes in the VA Corporate Data Warehouse.
90 days after hospital discharge or Veteran eligibility identification

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Paul L Hess, MD MS, Rocky Mountain Regional VA Medical Center, Aurora, CO

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

24 de julho de 2026

Conclusão Primária (Estimado)

30 de setembro de 2030

Conclusão do estudo (Estimado)

30 de setembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

15 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de julho de 2026

Primeira postagem (Real)

20 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))
  • QUE 25-018 (Número de outro subsídio/financiamento: VA Quality Enhancement Research Initiative (QUERI))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared publicly due to VA data governance and privacy requirements governing VA Corporate Data Warehouse data. Aggregate study results will be published in peer-reviewed journals.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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