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

15 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

585

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Paul L Hess, MD MS
  • Numero di telefono: (720) 857-6889
  • Email: paul.hess@va.gov

Backup dei contatti dello studio

Luoghi di studio

    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contatto:
        • Investigatore principale:
          • Paul L Hess, MD MS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • PATRIOT-HF intervention; pharmacist-assisted GDMT optimization
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in NIH Heart Failure Collaboratory Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

24 luglio 2026

Completamento primario (Stimato)

30 settembre 2030

Completamento dello studio (Stimato)

30 settembre 2030

Date di iscrizione allo studio

Primo inviato

15 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))
  • QUE 25-018 (Altro numero di sovvenzione/finanziamento: VA Quality Enhancement Research Initiative (QUERI))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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