Heart FailurePATRIOT-HFNCT07714239
Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure
A study testing Pharmacist/Cardiologist Virtual Team Digital Consultation in people with Heart Failure and Heart Failure, Systolic, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure, Systolic
- What is being tested?
- Pharmacist/Cardiologist Virtual Team Digital Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemodynamic instability
- Receiving comfort care measures alone or enrolled in hospice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Paul L Hess, MD MS, (720) 857-6889, paul.hess@va.gov
Paul L Hess, MD MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Heart Failure, Systolic
- Being tested
- Pharmacist/Cardiologist Virtual Team Digital Consultation
- Keywords
- Guideline-Directed Medical Therapy, Pharmacists, Medication Therapy Management, Quality Improvement, Veterans Health, Telemedicine, Implementation Science
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist/Cardiologist Virtual Team Digital ConsultationBehavioural
Also called PATRIOT-HF intervention; pharmacist-assisted GDMT optimization
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A composite GDMT metric assessing the breadth and completeness of guideline-recommended heart failure pharmacotherapy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days after hospital discharge or Veteran eligibility identification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 585 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul L Hess, MD MS, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714239
- Sponsor's protocol ID
- QUX 26-006
- Other IDs
- QUE 25-018
- Acronym
- PATRIOT-HF
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF) (QUE 25-018)
- ClinicalTrials.gov ID
- NCT07714239
- Acronym / sponsor ID
- PATRIOT-HF / QUX 26-006
- Conditions
- Heart Failure, Heart Failure, Systolic
- Keywords
- Guideline-Directed Medical Therapy, Pharmacists, Medication Therapy Management, Quality Improvement, Veterans Health, Telemedicine, Implementation Science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 585 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pharmacist/Cardiologist Virtual Team (Intervention) | Experimental | Behavioral: Pharmacist/Cardiologist Virtual Team Digital ConsultationVA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission to a VA medical center or VA-paid community hospital within the preceding 3 months with a primary diagnosis of heart failure
- 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
Key exclusion criteria (2 listed)
- Hemodynamic instability
- Receiving comfort care measures alone or enrolled in hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist/Cardiologist Virtual Team Digital ConsultationAlso: PATRIOT-HF intervention; pharmacist-assisted GDMT optimizationA 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. | Behavioural | Pharmacist/Cardiologist Virtual Team (Intervention) |
Primary outcome
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score
Time frame: 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.
6 secondary outcomes
Change in NIH Heart Failure Collaboratory Score
Time frame: From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)
All-cause mortality
Time frame: 30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)
Heart Failure Readmission
Time frame: 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
Time frame: 90 days after hospital discharge or Veteran eligibility identification
Medication-related adverse outcomes - bradycardia
Time frame: 90 after hospital discharge or Veteran eligibility identification
Medication-related adverse outcomes - hyperkalemia
Time frame: 90 days after hospital discharge or Veteran eligibility identification
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul L Hess, MD MS principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist/Cardiologist Virtual Team Digital Consultation in people with Heart Failure and Heart Failure, Systolic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul L Hess, MD MS ((720) 857-6889, paul.hess@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score (time frame: From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.