Quality ImprovementPHARM-HF-2NCT07460219
Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2
A study testing Education Only, Education and Feedback (E+F) and Primary Care Referral Nudges in people with Quality Improvement and Pharmacotherapy, run by Stanford University at 1 site in United States.
Trial summary
Nurse or pharmacist led GDMT management programs have been shown to effectively increase GDMT rates. The Veterans Healthcare Administration (VHA) has a pharmacist-based HF remote management program that uses an online, real-time, patient dashboard to optimize HF therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality Improvement, Pharmacotherapy, Heart Failure
- What is being tested?
- Education Only, Education and Feedback (E+F) and Primary Care Referral Nudges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 15 Dec 2026
- 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
- Primary care pharmacist within one of three VA regions (6, 10, and 19)
Who cannot join
- Site declined
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
Palo Alto Veterans Affairs Healthcare System
Palo Alto, California, 94304
About this study
Nurse or pharmacist led GDMT management programs have been shown to effectively increase GDMT rates. The Veterans Healthcare Administration (VHA) has a pharmacist-based HF remote management program that uses an online, real-time, patient dashboard to optimize HF therapy. However, only a minority of VHA patients with recent-onset HF received HF care from pharmacists, with many of the encounters being limited to monitoring and education. Expanding the pharmacist program is a goal, but how to successfully implement this is unclear.
The PHARM-HF-2 Project is a multi-site pragmatic randomized quality improvement project that evaluates two different interventions. First, the project evaluates if education and feedback messages increase the frequency of pharmacist HF medication management compared with education alone. Second, the project evaluates if primary care nudges to refer patients with heart failure to pharmacy care increase the frequency of pharmacist HF medication management compared with usual care.
Read more
PHARM-HF-2 is a cluster randomized project at the level of the clinical site in a stepped wedge design. A total of 22 VHA sites will be randomized to different time points at which they begin receiving the intervention. In the initial phase, all sites will receive education only. At intervals of 2 months, 4 sites will transition from education only to audit and feedback with education in a randomized order. By the end of the project, all sites will be receiving the monthly audit and feedback intervention.
The second implementation strategy is nested within the primary strategy among sites randomized to education and feedback. Primary care referral nudges will studied with a two-arm parallel design with randomization at the level of the primary care team (PACT team) with 1:1 allocation stratified by site. This nested evaluation will start four months into the study.
- Conditions
- Quality Improvement, Pharmacotherapy, Heart Failure
- Being tested
- Education Only, Education and Feedback (E+F), Primary Care Referral Nudges
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education OnlyOther
Pharmacists will be informed regarding the educational material on a VHA Sharepoint site. The educational information will include suggested titration protocols, education about heart failure medications, a frequently asked questions document, guideline documents, patient educational material, and recordings of Teams webinars on heart failure management. The pharmacists will be invited to a regular webinar regarding heart failure medication management.
Education and Feedback (E+F)Other
Primary care pharmacists with a heart failure action within the last year will receive a monthly Teams message. The monthly Teams message will contain information including their heart failure medication actions over the prior 3 month period. This data will be obtained from VHA pharmacy data. The message will also include reminders regarding the monthly educational sessions and access to the educational sharepoint. They will also receive a Teams calendar hold for the monthly educational meeting.
Primary Care Referral NudgesOther
Primary care clinicians will receive a weekly email that lists potential patients with HF with reduced ejection fraction with upcoming clinic visits that are not on optimal medication therapy. The message will suggest referral to PACT pharmacists for medication optimization.
| Study group | Role | What they receive |
|---|---|---|
| Education Only | Active comparator | Pharmacists practicing at sites randomized to Education Only Receives: Other: Education Only |
| Education and Feedback (E+F) without Primary Care Referral Nudges | Experimental | Pharmacists practicing at sites randomized to education and feedback but not primary care referral nudges in the nested implementation strategy. Receives: Other: Education and Feedback (E+F) |
| Education and Feedback (E+F) with Primary Care Referral Nudges | Experimental | Pharmacists practicing at sites randomized to education and feedback and the primary care referral nudges in the nested implementation strategy. Receives: Other: Education and Feedback (E+F); Other: Primary Care Referral Nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly heart failure medication adjustment encounters
Number of encounters in which pharmacist adjusted heart failure medications
Measured: Up to 12 months
Secondary outcomes (7)
Pharmacist Heart Failure Encounters
Number of encounters in which pharmacist documented heart failure care
Measured: Up to 12 months
Guideline medical therapy score
Composite score of heart failure medical therapy among patients with heart failure for patients within each pharmacists panel (Score range 0-18 with higher scores indicating higher amounts of medical therapy)
Measured: At 12 months follow-up
Beta-blocker therapy
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy
Measured: At 12 months follow-up
Renin-angiotensin system inhibitor (RASI) therapy
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy
Measured: At 12 months follow-up
Angiotensin receptor neprilysin inhibitor (ARNI) therapy
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy
Measured: At 12 months follow-up
Mineralocorticoid receptor antagonist (MRA) therapy
Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Measured: At 12 months follow-up
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy
Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy
Measured: At 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start16 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Crossover
- Model description
- This is a multisite randomized quality improvement project. The project evaluates two separate interventions to increase pharmacist HF medication adjustment. In a stepped wedge randomized design, the study will compare education and feedback versus education alone. The education and feedback intervention will be randomized at the level of the clinical site. A total of 22 VHA sites will be randomized to different time points at which they begin receiving the intervention. In the initial phase, all sites will receive education only. At intervals of 2 months, 4 sites will transition from education only to education and feedback in a randomized order. By the end of the project, all sites will be receiving the monthly education and feedback intervention. The second component of the project will be a parallel randomized project comparing primary care pharmacist referral nudges with usual care. This second project will be nested within sites randomized to education an
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Sandhu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460219
- Sponsor's protocol ID
- 67031
- Acronym
- PHARM-HF-2
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2
- ClinicalTrials.gov ID
- NCT07460219
- Acronym / sponsor ID
- PHARM-HF-2 / 67031
- Conditions
- Quality Improvement, Pharmacotherapy, Heart Failure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 10 Mar 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.
Nurse or pharmacist led GDMT management programs have been shown to effectively increase GDMT rates. The Veterans Healthcare Administration (VHA) has a pharmacist-based HF remote management program that uses an online, real-time, patient dashboard to optimize HF therapy. However, only a minority of VHA patients with recent-onset HF received HF care from pharmacists, with many of the encounters being limited to monitoring and education. Expanding the pharmacist program is a goal, but how to successfully implement this is unclear.
The PHARM-HF-2 Project is a multi-site pragmatic randomized quality improvement project that evaluates two different interventions. First, the project evaluates if education and feedback messages increase the frequency of pharmacist HF medication management compared with education alone. Second, the project evaluates if primary care nudges to refer patients with heart failure to pharmacy care increase the frequency of pharmacist HF medication management compared with usual care.
PHARM-HF-2 is a cluster randomized project at the level of the clinical site in a stepped wedge design. A total of 22 VHA sites will be randomized to different time points at which they begin receiving the intervention. In the initial phase, all sites will receive education only. At intervals of 2 months, 4 sites will transition from education only to audit and feedback with education in a randomized order. By the end of the project, all sites will be receiving the monthly audit and feedback intervention.
The second implementation strategy is nested within the primary strategy among sites randomized to education and feedback. Primary care referral nudges will studied with a two-arm parallel design with randomization at the level of the primary care team (PACT team) with 1:1 allocation stratified by site. This nested evaluation will start four months into the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a multisite randomized quality improvement project. The project evaluates two separate interventions to increase pharmacist HF medication adjustment. In a stepped wedge randomized design, the study will compare education and feedback versus education alone. The education and feedback intervention will be randomized at the level of the clinical site. A total of 22 VHA sites will be randomized to different time points at which they begin receiving the intervention. In the initial phase, all sites will receive education only. At intervals of 2 months, 4 sites will transition from education only to education and feedback in a randomized order. By the end of the project, all sites will be receiving the monthly education and feedback intervention. The second component of the project will be a parallel randomized project comparing primary care pharmacist referral nudges with usual care. This second project will be nested within sites randomized to education an
| Arm | Type | Receives |
|---|---|---|
| Education Only | Active comparator | Other: Education OnlyPharmacists practicing at sites randomized to Education Only |
| Education and Feedback (E+F) without Primary Care Referral Nudges | Experimental | Other: Education and Feedback (E+F)Pharmacists practicing at sites randomized to education and feedback but not primary care referral nudges in the nested implementation strategy. |
| Education and Feedback (E+F) with Primary Care Referral Nudges | Experimental | Other: Education and Feedback (E+F), Other: Primary Care Referral NudgesPharmacists practicing at sites randomized to education and feedback and the primary care referral nudges in the nested implementation strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care pharmacist within one of three VA regions (6, 10, and 19)
Key exclusion criteria (1 listed)
- Site declined
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 |
|---|---|---|
| Education OnlyPharmacists will be informed regarding the educational material on a VHA Sharepoint site. The educational information will include suggested titration protocols, education about heart failure medications, a frequently asked questions document, guideline documents, patient educational material, and recordings of Teams webinars on heart failure management. The pharmacists will be invited to a regular webinar regarding heart failure medication management. | Other | Education Only |
| Education and Feedback (E+F)Primary care pharmacists with a heart failure action within the last year will receive a monthly Teams message. The monthly Teams message will contain information including their heart failure medication actions over the prior 3 month period. This data will be obtained from VHA pharmacy data. The message will also include reminders regarding the monthly educational sessions and access to the educational sharepoint. They will also receive a Teams calendar hold for the monthly educational meeting. | Other | Education and Feedback (E+F) with Primary Care Referral Nudges, Education and Feedback (E+F) without Primary Care Referral Nudges |
| Primary Care Referral NudgesPrimary care clinicians will receive a weekly email that lists potential patients with HF with reduced ejection fraction with upcoming clinic visits that are not on optimal medication therapy. The message will suggest referral to PACT pharmacists for medication optimization. | Other | Education and Feedback (E+F) with Primary Care Referral Nudges |
Primary outcome
Monthly heart failure medication adjustment encounters
Time frame: Up to 12 months
Number of encounters in which pharmacist adjusted heart failure medications
7 secondary outcomes
Pharmacist Heart Failure Encounters
Time frame: Up to 12 months
Guideline medical therapy score
Time frame: At 12 months follow-up
Beta-blocker therapy
Time frame: At 12 months follow-up
Renin-angiotensin system inhibitor (RASI) therapy
Time frame: At 12 months follow-up
Angiotensin receptor neprilysin inhibitor (ARNI) therapy
Time frame: At 12 months follow-up
Mineralocorticoid receptor antagonist (MRA) therapy
Time frame: At 12 months follow-up
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy
Time frame: At 12 months follow-up
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Only, Education and Feedback (E+F) and Primary Care Referral Nudges in people with Quality Improvement and Pharmacotherapy, run by Stanford University 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly heart failure medication adjustment encounters (time frame: Up to 12 months). 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 10 Mar 2026.