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

NCT07714239 | Not Yet Recruiting

• 2 other identifiers: QUX 26-006QUE 25-018
• Study Type: interventional
• Target: 585
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Heart Failure, Systolic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in NIH Heart Failure Collaboratory Score

  From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)

• All-cause mortality

  30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)

• Heart Failure Readmission

  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

  90 days after hospital discharge or Veteran eligibility identification

• Medication-related adverse outcomes - bradycardia

  90 after hospital discharge or Veteran eligibility identification

Study Arms (2)

Pharmacist/Cardiologist Virtual Team (Intervention)

EXPERIMENTAL

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

Usual Care (Control Period)

NO INTERVENTION

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.

Interventions

Pharmacist/Cardiologist Virtual Team Digital Consultation BEHAVIORAL

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.

Also known as: PATRIOT-HF intervention; pharmacist-assisted GDMT optimization

Pharmacist/Cardiologist Virtual Team (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Paul L Hess, MD MS

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul L Hess, MD MS

CONTACT

(720) 857-6889; paul.hess@va.gov

Lexus L Ujano-De Motta, BS

CONTACT

(808) 990-3993; lexus.ujano-demotta@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label pragmatic implementation trial. Blinding of participants or care providers is not feasible given the nature of the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)