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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07714239
Acronym
PATRIOT-HF
Enrollment
585
Registered
2026-07-20
Start date
2026-11-01
Completion date
2030-09-30
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Failure, Systolic

Keywords

Guideline-Directed Medical Therapy, Pharmacists, Medication Therapy Management, Quality Improvement, Veterans Health, Telemedicine, Implementation Science

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPharmacist/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) and are tailored to individual clinical presentations. The pharmacist arranges outpatient follow-up and delivers medication adherence education.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

This is an open-label pragmatic implementation trial. Blinding of participants or care providers is not feasible given the nature of the intervention.

Intervention model description

Cluster-randomized stepped-wedge design with 6 VA medical centers randomized to 3 implementation waves. Implementation occurs every 6 months at 2 sites per wave. Sites serve as their own controls during the control period prior to receiving the intervention. Covariate-constrained randomization is used to balance site-level characteristics across waves.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Guideline-Directed Medical Therapy (GDMT) Optimization ScoreFrom 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.

Secondary

MeasureTime frameDescription
Change in NIH Heart Failure Collaboratory ScoreFrom 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.
All-cause mortality30 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.
Heart Failure Readmission30 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.
Medication-related adverse outcomes - acute kidney injury90 days after hospital discharge or Veteran eligibility identificationAcute kidney injury identified by creatinine levels and ICD diagnostic codes in the VA Corporate Data Warehouse.
Medication-related adverse outcomes - bradycardia90 after hospital discharge or Veteran eligibility identificationBradycardia identified by vital sign readings and ICD diagnostic codes in the VA Corporate Data Warehouse.
Medication-related adverse outcomes - hyperkalemia90 days after hospital discharge or Veteran eligibility identificationHyperkalemia identified by potassium laboratory values and ICD diagnostic codes in the VA Corporate Data Warehouse.

Countries

United States

Contacts

CONTACTPaul L Hess, MD MS
paul.hess@va.gov(720) 857-6889
CONTACTLexus L Ujano-De Motta, BS
lexus.ujano-demotta@va.gov(808) 990-3993
PRINCIPAL_INVESTIGATORPaul L Hess, MD MS

Rocky Mountain Regional VA Medical Center, Aurora, CO

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026