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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Heart Failure, Systolic
• Intervention / Treatment: Behavioral: Pharmacist/Cardiologist Virtual Team Digital Consultation

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.

• Study Type: Interventional
• Enrollment (Estimated): 585
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul L Hess, MD MS; Phone Number: (720) 857-6889; Email: paul.hess@va.gov
• Study Contact Backup: Name: Lexus L Ujano-De Motta, BS; Phone Number: (808) 990-3993; Email: lexus.ujano-demotta@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Paul L Hess, MD MS; Phone Number: 720-857-6889; Email: paul.hess@va.gov
      • Principal Investigator: Paul L Hess, MD MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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) and are tailored to individual clinical presentations. The pharmacist arranges outpatient follow-up and delivers medication adherence education.; Other Names: PATRIOT-HF intervention; pharmacist-assisted GDMT optimization
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NIH Heart Failure Collaboratory Score	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Paul L Hess, MD MS, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Estimated): July 24, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Medication Therapy Management; Veterans Health; Implementation Science; Quality Improvement; Pharmacists; Guideline-Directed Medical Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Heart Failure, Systolic; Health Care Facilities Workforce and Services; Health Personnel; Pharmacists
• Other Study ID Numbers: QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI)); QUE 25-018 (Other Grant/Funding Number: VA Quality Enhancement Research Initiative (QUERI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No